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

2326–2350 of 39824

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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-0620-2026·2025-12-03
Blood set 480233 recalled over backflow from piggyback containers
B. Braun Medical is recalling 5,448 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-0633-2026·2025-12-03
IV set 490283 recalled over backflow between primary and secondary containers
B. Braun Medical is recalling 65,904 units iv administration 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/ B/C VALVE 53 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-0640-2026·2025-12-03
Universal infusion sets recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 49,330,370 Infusomat administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Infusomat 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. UNIV.15DROP PUMP SET W/3 SAFELINE LL;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0672-2026·2025-12-03
IV set 490519 recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 1,080 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, 132 I
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0664-2026·2025-12-03
IV set 490315 recalled over backflow between primary and secondary containers
B. Braun Medical is recalling 11,832 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/ML,2 CA
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

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2326–2350 of 39824