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

4101–4125 of 89480

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
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-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-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-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-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-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-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-0709-2026·2025-12-03
Outlook set 354212 recalled over piggyback backflow and occlusion risk
B. Braun Medical is recalling 162,648 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/2 CARESITE; C
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0697-2026·2025-12-03
IV set 480231 recalled over backflow from secondary piggyback containers
B. Braun Medical is recalling 85,176 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-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-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-0583-2026·2025-12-03
Skin cancer aid recalled because it may not meet specifications
DermaSensor is recalling nine affected units of its software-aided diagnostic device because it may not meet specifications, risking incorrect results or a delayed referral.
Product
DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer
Category
Medical Device
Distribution
8 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-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
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-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-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 (Food)·H-0206-2026·2025-12-03
Cinnamon whiskey pecans recalled over undeclared cashews in the product
Nat's Nuts is recalling 50 cases, 600 units, of Cinnamon Whiskey Pecans 4 oz because the product contains undeclared cashews.
Product
Nat's Nuts Cinnamon Whiskey Pecans, 4 oz.
Category
Food
Distribution
9 states
HighFDA (Food)·H-0207-2026·2025-12-03
Ice cream bars recalled over undeclared wheat and soy allergens
Jeni's Splendid Ice Creams is recalling 3,767 cases of Passion Fruit Dreamsicle Ice Cream Bars over undeclared wheat and soy.
Product
Jeni's Passion Fruit Dreamsicle Ice Cream Bars, 3 FL OZ (89 ML)/9 FL OZ (266 ML), packaged 3 bars per retail carton with Item UPC: 850060644122, packed 8 retail cartons per case with Case UPC: 10850060644129
Category
Food
Distribution
10 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-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-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-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

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4101–4125 of 89480