Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

1701–1725 of 27375

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-0617-2026·2025-12-03
Blood set 490355 recalled over backflow into the primary container
B. Braun Medical is recalling 24,624 units 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 W/ 170
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-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-0641-2026·2025-12-03
IV set 490357 recalled over backflow from secondary piggyback containers
B. Braun Medical is recalling 98,688 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/ML
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-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-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-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-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-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-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-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-0616-2026·2025-12-03
Blood set 490196 recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 7,344 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 124 IN.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0645-2026·2025-12-03
IV set 490067 recalled over medication backflow between IV containers
B. Braun Medical is recalling 407,800 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 5CARESITE 1 ULR
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-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-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-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-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-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-0642-2026·2025-12-03
IV set 490385 recalled over medication backflow between IV containers
B. Braun Medical is recalling 168,816 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 numbers: 1. IV ADMIN SET, 10 DROPS/ML,
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-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-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

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1701–1725 of 27375