December 2025 recalls

744 recalls were announced in December 2025.

What the numbers show

Critical: 102
Severe: 54
High: 363
Moderate: 217
Low: 8

Of the 744 recalls this month scored against our rubric, 14% are Critical, 7% are Severe.

Which agencies issued them

601–700 of 744

HighFDA (Devices)·Z-0610-2026·2025-12-03
Extension set 490358 recalled over backflow into the primary container
B. Braun Medical is recalling 1,200 units extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15D, 144 IN.; Cat
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0703-2026·2025-12-03
IV set 490301 recalled over backflow from secondary piggyback containers
B. Braun Medical is recalling 31,392 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV AD.SET W/15 DR 128 IN, E
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0671-2026·2025-12-03
Vented pump sets recalled over medication backflow and occlusion risk
B. Braun Medical is recalling 12,168 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 15 DROPS/ML
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0696-2026·2025-12-03
IV set 490437 recalled over piggyback backflow and occlusion risk
B. Braun Medical is recalling 4,536 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 15 DROPS/ML
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0681-2026·2025-12-03
IV set 490426 recalled over piggyback backflow and occlusion risk
B. Braun Medical is recalling 63,192 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/10 DROPS, 13
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0687-2026·2025-12-03
IV set 490407 recalled over medication backflow between IV containers
B. Braun Medical is recalling 10,896 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/CARESITE EXT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0677-2026·2025-12-03
IV set 490612 recalled over medication backflow between IV containers
B. Braun Medical is recalling 5,952 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. 15DR 2SAFELINE 1CARESITE 1S
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0658-2026·2025-12-03
IV set 470005 recalled over medication backflow and priming failure
B. Braun Medical is recalling 29,900 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET 15DR 3 CARESITE, 124
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0650-2026·2025-12-03
IV set 490317 recalled over backflow and occlusion risk
B. Braun Medical is recalling 6,650 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV AD SET CARESITE 127 IN.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0580-2026·2025-12-03
Expandable spinal cages recalled because they may lose height or collapse
Medtronic Sofamor Danek is recalling 275,260 Catalyft PL and PL40 expandable interbody spacers because the cage may lose height or collapse, risking migration or neurological injury.
Product
Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2. SPACER 6068076 CATALYFT PL LONG 7MM, Model Number: 6068076. 3. SPACER 6068093 CATALYFT PL SHORT 9MM, Mo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0631-2026·2025-12-03
Extension set 490629 recalled over backflow and priming occlusion
B. Braun Medical is recalling 13,128 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXTENSION SET, 25 IN.; Catalog Numb
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0667-2026·2025-12-03
Infusion pump sets recalled over medication backflow and occlusion
B. Braun Medical is recalling 37,656 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS, 16
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0634-2026·2025-12-03
Extension sets recalled over piggyback backflow into primary containers
B. Braun Medical is recalling 23,650 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXTENSION SET W/ ULTRAPORT, 48 IN.;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0612-2026·2025-12-03
Anesthesia set 490444 recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 88,200 anesthesia IV sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15D 2 CARESITE LA
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0625-2026·2025-12-03
Caresite set 354202 recalled over backflow and inability to prime
B. Braun Medical is recalling 2,871,707 units caresite sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. Primary Gravity IV Set with 2 CARESITE¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0622-2026·2025-12-03
Burette set 490159 recalled over backflow into the primary container
B. Braun Medical is recalling 7,240 burette sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Burette Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. BURETTE SET W/ 2 CARESITE, 134 IN.; C
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0717-2026·2025-12-03
IV set 490508 recalled over backflow into the primary container
B. Braun Medical is recalling IV administration set catalog number 490508 over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 15DROPS/ML;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0655-2026·2025-12-03
IV set 457504 recalled over medication backflow and priming failure
B. Braun Medical is recalling 80,650 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET W/2 CARESITE & 2 ULT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0649-2026·2025-12-03
IV set 490208 recalled over medication backflow between IV containers
B. Braun Medical is recalling 40,008 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DR / mL W
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0691-2026·2025-12-03
IV set 490408 recalled over backflow between primary and secondary containers
B. Braun Medical is recalling 24,072 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 2 CARESITES,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0628-2026·2025-12-03
Smallbore extension sets recalled over backflow and inability to prime
B. Braun Medical is recalling 30,250 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. ET08US EXTENSION SET W/ULTRA Y SITE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0723-2026·2025-12-03
Imaging software recalled over a bug that can lose clinical information
Intelerad Medical Systems is recalling 19 IntelePACS InteleConnect and TechPortal installations because a bug can cause data loss in the Relevant Clinical Info field.
Product
IntelePACS - InteleConnect / TechPortal
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·25V835000·2025-12-03
2026 Volkswagen ID.4 and Atlas vehicles recalled for incorrect wheel bolts
Volkswagen is recalling 27 vehicles with potentially incorrect wheel bolts that could detach during driving. Owners should not drive their vehicles until bolts are inspected and replaced by a dealer at no cost.
Product
VOLKSWAGEN — VOLKSWAGEN ID.4, ATLAS CROSS SPORT, ATLAS
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0680-2026·2025-12-03
Gravity IV sets recalled over medication backflow and inability to prime
B. Braun Medical is recalling 12,200 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. NF1503 15 DR UNIV SPIKE, IN
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0720-2026·2025-12-03
Anesthesia vaporizers recalled over the potential for anesthesia leakage
Mindray is recalling 148 Sevoflurane V90 Electronic Vaporizers used with the A9 Anesthesia System over the potential for anesthesia leakage.
Product
Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00. 2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00. Product Description: Th
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0714-2026·2025-12-03
ULTRASITE set 352049-C recalled over backflow and inability to prime
B. Braun Medical is recalling 41,400 ULTRASITE sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
ULTRASITE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 2 ULTRASITE VLV, 10
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0695-2026·2025-12-03
IV set 490193 recalled over backflow and inability to prime
B. Braun Medical is recalling 111,312 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15DR HF 4-WAY
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0602-2026·2025-12-03
Respiratory test panels recalled over elevated risk of false negative results
BioFire Diagnostics is recalling 23 kits of the BioFire Respiratory Panel 2.1 because unintended movement of pouch chemistry may cause false negative results and control failures.
Product
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0584-2026·2025-12-03
Blood lead test kits recalled over mislabeled calibration buttons
Magellan Diagnostics is recalling 1,774 LeadCare II Blood Lead Test Kits because calibration buttons used in kitting were labelled with the wrong lot number.
Product
The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare¿ II Test Kit is provided with the following materials: " Sensors (2 Containers of 24 sensors each; 48 tests) " Treatment Reagent Tubes (2 packag
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0702-2026·2025-12-03
IV set 354208 recalled over medication backflow and priming failure
B. Braun Medical is recalling 126,050 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15DR, CARESIT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0682-2026·2025-12-03
IV set 490488 recalled over backflow between primary and secondary containers
B. Braun Medical is recalling 187,464 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0698-2026·2025-12-03
IV set 490274 recalled over backflow into the primary container
B. Braun Medical is recalling 98,568 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 3 CARESITE LAD
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0711-2026·2025-12-03
SafeDAY set 352635 recalled over piggyback backflow and inability to prime
B. Braun Medical is recalling 200,917 SafeDAY sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 60 DROP W/2 SAFEDAY; Cat
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0721-2026·2025-12-03
Isoflurane vaporizers recalled over the potential for anesthesia leakage
Mindray is recalling 54 Isoflurane V90 Electronic Vaporizers used with the A9 Anesthesia System over the potential for anesthesia leakage.
Product
Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00. 2. Exchange Iso E_Vap. (Safety Filling adapter), Part Number E115-066758-00. Product Description: The
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0674-2026·2025-12-03
IV set 490507 recalled over backflow and inability to prime
B. Braun Medical is recalling 48,672 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMINISTRATION SET WITH
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0707-2026·2025-12-03
Outlook set 354213 recalled over backflow into the primary container
B. Braun Medical is recalling 18,072 units outlook sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK IV SET 15DROP W/3 CARESITE; C
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0578-2026·2025-12-03
IV set 490487 recalled over piggyback backflow and occlusion risk
B. Braun Medical is recalling 23,160 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0596-2026·2025-12-03
Laboratory automation recalled over sample tubes with mismatched labels
Inpeco is recalling 14 FlexLab systems because the aliquoter module may produce secondary sample tubes without labels or with mismatched labels.
Product
FlexLab (FLX); Version: FLX-217-40;
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0595-2026·2025-12-03
Laboratory automation recalled over unlabelled or mismatched secondary sample tubes
Inpeco is recalling a FlexLab system because the aliquoter module may produce secondary sample tubes without labels or with mismatched labels, risking delayed or erroneous results.
Product
FlexLab (FLX); Version: FLX-217-10;
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0632-2026·2025-12-03
Short extension sets recalled over piggyback backflow and occlusion
B. Braun Medical is recalling 13,600 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXT SET W/ B/C VLV, ULTRAPORT, 57 I
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0684-2026·2025-12-03
Anesthesia set 490472 recalled over piggyback backflow and occlusion risk
B. Braun Medical is recalling 10,536 units anesthesia iv sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADM 15D 2 CARESITE, SAFE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0588-2026·2025-12-03
Heated massage tables recalled over heat components that can smolder
Pivotal Health Solutions is recalling 464 Quantum Intersegmental Tables because damage to the heat function components can lead to overheating, smoldering and melting of the vinyl cushion.
Product
Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0630-2026·2025-12-03
IV extension sets recalled over backflow between piggyback and primary containers
B. Braun Medical is recalling 43,452 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. EXTENSION SET, 18 IN; Catalog Numb
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0604-2026·2025-12-03
ADDitIV sets recalled over backflow between primary and secondary containers
B. Braun Medical is recalling 100 ADDitIV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. V1782F UNIV IV SET W/0.2 MICRON FILTER; C
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0665-2026·2025-12-03
IV set 490489 recalled over piggyback backflow and inability to prime
B. Braun Medical is recalling 3,120 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15DR, 92 IN W/
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0582-2026·2025-12-03
Demonstration only gel recalled because it may be placed in patients
Straumann USA is recalling 61 units of Emdogain because product intended for demonstration purposes only could be placed in patients.
Product
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0614-2026·2025-12-03
Anesthesia set 490468 recalled over backflow and inability to prime
B. Braun Medical is recalling 58,752 anesthesia IV sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 117 IN.; Catalog N
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0668-2026·2025-12-03
IV set 490504 recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 36,936 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0606-2026·2025-12-03
Anesthesia set 490189 recalled over piggyback backflow and occlusion risk
B. Braun Medical is recalling 32,436 anesthesia IV sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 108
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0710-2026·2025-12-03
Rate flow sets recalled over backflow and inability to prime
B. Braun Medical is recalling 150,664 RATE FLOW sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
RATE FLOW set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. RATEFLOW ADMIN 15 DROP W/2 CARESITE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0669-2026·2025-12-03
High volume IV sets recalled over piggyback backflow and occlusion
B. Braun Medical is recalling 190,625 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15 DROP W/ CAR
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0647-2026·2025-12-03
Single lot IV sets recalled over backflow and priming occlusion
B. Braun Medical is recalling 48 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN 15D, 2 B/C VLV, 3
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0626-2026·2025-12-03
Caresite set 354207 recalled over backflow and priming occlusion
B. Braun Medical is recalling 381,850 Caresite primary gravity sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Primary Gravity Filtered Set with 2 CARE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0603-2026·2025-12-03
Primary gravity sets recalled over backflow from secondary containers
B. Braun Medical is recalling 43,900 ADDitIV primary gravity sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. Primary Gravity IV Set, 2 Non-Needle-Fre
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0587-2026·2025-12-03
Q400 massage tables recalled over heat components that can overheat
Pivotal Health Solutions is recalling 34 Quantum Intersegmental Tables, model Q400, because damage to the heat function components can lead to overheating and smoldering.
Product
Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0599-2026·2025-12-03
Myriad handpieces recalled because packaging tape contains undisclosed latex
Stryker is recalling 39,148 NICO Myriad Handpieces because tape used to secure components in the packaging contains latex despite the products being labelled latex-free.
Product
NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP - MINOP; NN-8003 13x10 MHP; NN-8004 13x13 MHP; NN-8005 15x25 MHP GAAB; NN-8006 11X10 MHP; NN-8007 11x13 MHP; NN-8008 19x28 MHP OI; NN-8010 17x31.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0646-2026·2025-12-03
IV set 457506 recalled over piggyback backflow and occlusion risk
B. Braun Medical is recalling 1,019 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET W/2 CARESITE & 1 ULT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0694-2026·2025-12-03
IV administration sets recalled over backflow from piggyback containers
B. Braun Medical is recalling 2,544 IV administration sets over the potential for medication to flow back from secondary piggyback containers into primary containers, and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 124 IN.; Catal
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0601-2026·2025-12-03
Brain access devices recalled because packaging tape contains latex
Stryker is recalling 39,148 NICO BrainPath devices because tape used to secure components in the packaging contains latex despite the products being labelled latex-free.
Product
NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026 BrainPath Shephard's Hook - Budde; NN-8042 BrainPath Shephard's Hook - Greenberg LK;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0692-2026·2025-12-03
Large volume IV sets recalled over piggyback backflow and occlusion risk
B. Braun Medical is recalling 45,288 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. 130 IN. IV ADMIN SET W/ 9 I
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0619-2026·2025-12-03
Blood administration sets recalled over backflow and priming failure
B. Braun Medical is recalling 164,568 blood administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Y-TYPE BLOOD SET, HAND P
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0704-2026·2025-12-03
Infusion sets recalled over backflow from secondary bags into primary
B. Braun Medical is recalling 122,232 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 129 IN, 3 CAR
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0689-2026·2025-12-03
Secondary IV sets recalled over backflow into the primary container
B. Braun Medical is recalling 25,728 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, QUAD MANIFOLD
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0722-2026·2025-12-03
Hot and cold wraps recalled over microwave instructions causing burns
DJO is recalling 1,594 Cold Form Wraps because the instructions tell users to microwave the wrap for three minutes, which may cause leaks or second degree burns.
Product
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0705-2026·2025-12-03
Small volume IV sets recalled over backflow and priming failure
B. Braun Medical is recalling 4,488 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. AESTHESIA IV SET, 127 in.;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0638-2026·2025-12-03
Caresite extension sets recalled over piggyback backflow and occlusion
B. Braun Medical is recalling 32,500 Caresite extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Caresite Extension Set_Export; Cata
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0708-2026·2025-12-03
Outlook pump sets recalled over backflow into the primary container
B. Braun Medical is recalling 2,352 Outlook pump sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK PUMP SET 3 CARESITE LADS 133
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0608-2026·2025-12-03
Anesthesia IV sets recalled over backflow and inability to prime
B. Braun Medical is recalling 14,712 anesthesia IV sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV AD. SET,15 DROPS/ML, W/EXT S
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0594-2026·2025-12-03
Diabetes clinic software recalled over incorrect sensor glucose graph data
Medtronic MiniMed is recalling 12,126 CareLink Clinic installations because a software error displays incorrect data on the 24-hour sensor glucose overview graph.
Product
CareLink Clinic, REF: MMT-7350
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0706-2026·2025-12-03
Outlook infusion sets recalled over backflow and inability to prime
B. Braun Medical is recalling 6,672 Outlook sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK PUMP SET,3 CARESITE LADS,115
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0693-2026·2025-12-03
Standard IV sets recalled over medication backflow from piggyback containers
B. Braun Medical is recalling 41,976 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0611-2026·2025-12-03
Anesthesia infusion sets recalled over backflow into the primary bag
B. Braun Medical is recalling 19,392 anesthesia IV sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15 DROPS/ML 125 I
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0600-2026·2025-12-03
Illumination packs recalled because packaging tape contains undisclosed latex
Stryker is recalling 39,148 NICO Myriad Illumination Packs because tape used to secure components in the packaging contains latex despite the products being labelled latex-free.
Product
NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0605-2026·2025-12-03
ADDitIV set 352062 recalled over backflow and inability to prime
B. Braun Medical is recalling 12,700 ADDitIV sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. PB602VSL NON-VENT SET 103-IN-DR; Catalog
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0648-2026·2025-12-03
Administration set 354209 recalled over backflow and inability to prime
B. Braun Medical is recalling 89,552 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ANES 15DROP W/2 CARESITE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0643-2026·2025-12-03
IV set NF1270A recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 13,870 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. NF1270A SAFELINE ANESTHESIA
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0713-2026·2025-12-03
SAFELINE set 352604 recalled over backflow from secondary containers
B. Braun Medical is recalling 46,250 SAFELINE sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
SAFELINE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. UNIVERSAL IV ADMIN SET; Catalog Numb
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0627-2026·2025-12-03
Extension set 473309 recalled over backflow and inability to prime
B. Braun Medical is recalling 11,650 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. AS152V2DLL; Catalog Number: 473309.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0699-2026·2025-12-03
IV set 490239 recalled over medication backflow between IV containers
B. Braun Medical is recalling 5,100 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 103 IN.; Catal
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0635-2026·2025-12-03
Extension set 490234 recalled over piggyback backflow and occlusion risk
B. Braun Medical is recalling 27,480 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXT SET ULTRAPORT STOPCOCK, 37IN.;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0623-2026·2025-12-03
CARESAFE set 354302 recalled over backflow and inability to prime
B. Braun Medical is recalling 4,438 CARESAFE sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
CARESAFE utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. CARESAFE IV ADMIN SET w/AIRSTOP, 104 IN
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0615-2026·2025-12-03
IV set 490349 recalled over backflow from secondary piggyback containers
B. Braun Medical is recalling 24,648 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
B.BRAUN utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 60 DROPS/ML,141 in.; Cata
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0652-2026·2025-12-03
IV set 490241 recalled over backflow and inability to prime
B. Braun Medical is recalling 66,792 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET HF STOPCOCK,10
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0662-2026·2025-12-03
IV set 490367 recalled over medication backflow and priming failure
B. Braun Medical is recalling 6,768 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/60 DR/ML, CA
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0659-2026·2025-12-03
IV set 490242 recalled over backflow into the primary bag
B. Braun Medical is recalling 129,480 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 60 DROP/ML, 10
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0690-2026·2025-12-03
IV set 490303 recalled over piggyback backflow and occlusion risk
B. Braun Medical is recalling 32,304 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET,3 CARESITE LAD
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0618-2026·2025-12-03
Blood set 490530 recalled over backflow and inability to prime
B. Braun Medical is recalling 33,528 blood administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Y-TYPE BLOOD SET, 3 CARS
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0670-2026·2025-12-03
IV set 352636 recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 20,694,734 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15 DR W/2 SAFE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0679-2026·2025-12-03
IV set 490025 recalled over backflow into the primary container
B. Braun Medical is recalling 15,250 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. PB1500 15 DROP IV SET W/2 S
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0637-2026·2025-12-03
Extension set 456521 recalled over backflow and priming occlusion
B. Braun Medical is recalling 61,423 units extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. ANESTHESIA SET W/ SAFEPORT MANIFOL
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0636-2026·2025-12-03
Extension set 490238 recalled over piggyback backflow and occlusion risk
B. Braun Medical is recalling 11,800 units extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXT SET W/ 6 B/C VALVES, 17 IN; Cat
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0639-2026·2025-12-03
Extension set V5405 recalled over backflow and inability to prime
B. Braun Medical is recalling 300 units extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXT/2INJ/FLBL/FML LRLK/CV 34; Catal
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0654-2026·2025-12-03
IV set 354210 recalled over backflow and inability to prime
B. Braun Medical is recalling 1,861,111 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ANES 15DROP W/2 CARESITE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0607-2026·2025-12-03
IV set 477002 recalled over backflow from secondary piggyback containers
B. Braun Medical is recalling 22,928 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 132
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0657-2026·2025-12-03
IV set 490427 recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 224,856 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 15 DROPS/ML
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0629-2026·2025-12-03
Extension set 456520 recalled over backflow and priming occlusion
B. Braun Medical is recalling 2,100 units extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. ANES SET W/DUAL FEM.LL SAFEPORT MAN
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0613-2026·2025-12-03
Anesthesia set 490476 recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 19,320 units anesthesia iv sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 2-HIGH FLOW STPCK
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0609-2026·2025-12-03
Anesthesia set 490477 recalled over backflow and inability to prime
B. Braun Medical is recalling 36,552 units anesthesia iv sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 134
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0660-2026·2025-12-03
IV set 490343 recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 1,272 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET,2 CARESITE, TR
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0661-2026·2025-12-03
IV set 490309 recalled over backflow into the primary bag
B. Braun Medical is recalling 259,392 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 2 CARESITE,
Category
Medical Device
Distribution
0 states

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