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

2376–2400 of 39948

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-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-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-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-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-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-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-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
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-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-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-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-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-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-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-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-0663-2026·2025-12-03
IV set 490400 recalled over backflow and inability to prime
B. Braun Medical is recalling 19,104 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-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-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-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

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2376–2400 of 39948