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

1526–1550 of 13414

HighFDA (Devices)·Z-0583-2026·2025-12-03
DermaSensor skin cancer detection device may produce incorrect diagnostic results
The FDA is recalling DermaSensor Model 10101 because it may not meet performance specifications, potentially causing incorrect diagnostic results or delayed referrals for patients with suspected skin cancer.
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-0682-2026·2025-12-03
IV Administration Sets Recalled Due to Medication Backflow Risk
B Braun Medical is recalling IV Administration Sets due to potential medication backflow from secondary containers into primary containers and inability to prime the line. Approximately 187,464 units are affected worldwide.
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-0627-2026·2025-12-03
B Braun Extension Sets for IV Pumps: Medication Backflow and Occlusion Risk
B Braun Medical is recalling Extension Sets used in IV administration systems due to potential backflow of medication from secondary IV containers into primary containers, which could also cause inability to prime the line.
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-0623-2026·2025-12-03
B Braun CARESAFE IV Administration Sets Recalled for Medication Backflow Risk
B Braun Medical is recalling CARESAFE IV administration sets due to potential medication backflow from secondary to primary containers and inability to prime. Approximately 4,438 units are affected worldwide.
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-0619-2026·2025-12-03
Blood Administration Set Recall Due to Backflow and Priming Issues
B Braun Medical Inc is recalling 164,568 Blood Administration Sets due to potential backflow of medication from secondary IV containers into primary containers and inability to prime. The affected sets are used in gravity and pump-based IV administration systems.
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-0685-2026·2025-12-03
IV Administration Sets with Potential Medication Backflow and Priming Issues
B Braun IV administration sets used with gravity and pump infusion systems may allow medication to flow backward from secondary containers into primary containers and prevent proper priming. Discontinue use and contact the manufacturer.
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 ADMN SET W/15 DROP, ULTR
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0622-2026·2025-12-03
IV Burette Sets Recalled Due to Potential Medication Backflow Risk
B Braun Medical Inc is recalling 7,240 Burette Sets used in IV administration due to potential medication backflow from secondary containers and inability to prime. The affected catalog number 490159 was distributed worldwide.
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-0625-2026·2025-12-03
IV Administration Sets: Potential Medication Backflow and Occlusion Risk
B Braun Medical's Caresite injection sites in IV administration sets may allow medication to flow backward from secondary containers into primary containers and prevent proper line priming. Approximately 2.8 million units affected worldwide.
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-0587-2026·2025-12-03
Quantum Intersegmental Table Model Q400 heating malfunction fire risk
Pivotal Health Solutions is recalling the Quantum Intersegmental Table Model Q400 because the heat function may become damaged when patients press on component areas, potentially causing overheating and smoldering of the vinyl cushion.
Product
Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0714-2026·2025-12-03
B Braun IV Administration Sets Recalled for Medication Backflow Risk
B Braun Medical recalls 41,400 ULTRASITE IV administration sets worldwide due to potential backflow of medication from secondary IV containers and 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-0628-2026·2025-12-03
B Braun IV Extension Sets Recalled for Potential Medication Backflow
B Braun Medical Inc is recalling 30,250 Extension Sets used with infusion pumps due to potential medication backflow from secondary IV containers into primary containers and inability to prime the line.
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-0615-2026·2025-12-03
B.Braun IV Administration Sets Recalled for Medication Backflow Risk
B.Braun IV administration sets used with certain infusion pumps are recalled due to potential medication backflow from secondary containers into primary containers and inability to prime. No illnesses reported.
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-0600-2026·2025-12-03
Medical Device Illumination Pack Recalled for Undisclosed Latex in Packaging
Stryker Corporation is recalling the NICO Myriad Illumination Pack because tape used in packaging contains latex despite the product being labeled as latex-free. Latex may cause allergic reactions in sensitive individuals.
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-0708-2026·2025-12-03
B Braun Medical IV Administration Sets: Medication Backflow and Occlusion Risk
B Braun Medical Inc is recalling approximately 2,352 Outlook IV administration sets due to potential backflow of medication into primary containers and inability to prime. No injuries have been reported.
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-0691-2026·2025-12-03
B. Braun IV Administration Sets Recalled for Medication Backflow Risk
B. Braun Medical Inc is recalling 24,072 IV administration sets used with multiple pump models due to potential backflow of medication from secondary containers into primary containers and 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-0645-2026·2025-12-03
IV Administration Sets Recalled for Potential Medication Backflow and Occlusion Risk
B Braun Medical Inc recalls 407,800 IV administration sets for potential backflow of medication and occlusion. The defect may prevent proper medication delivery in gravity and pump administration systems.
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-0649-2026·2025-12-03
B. Braun IV Administration Sets recalled due to medication backflow risk
B. Braun IV Administration Sets used with multiple infusion pumps are being recalled due to potential for medication backflow from secondary into primary IV containers and inability to prime properly.
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-0702-2026·2025-12-03
IV Administration Sets Recalled Due to Backflow and Occlusion Risk
B Braun Medical is recalling IV Administration Sets due to a risk of medication backflow from secondary to primary IV containers and inability to prime. Affected catalog numbers 477002 and 477017 were distributed worldwide.
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-0697-2026·2025-12-03
IV Administration Sets Risk Medication Backflow and Priming Failure
B Braun Medical IV administration sets used with certain infusion pumps may allow medication to flow backward from secondary containers into primary containers and fail to prime. This could result in incorrect medication delivery.
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-0638-2026·2025-12-03
Extension Set Recall: Risk of Backflow in IV Administration Sets
B. Braun Medical Inc is recalling 32,500 Extension Sets used in IV administration due to potential backflow of medication and inability to prime the infusion lines.
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-0711-2026·2025-12-03
IV Administration Set with SafeDAY Recalled Due to Backflow Risk
B Braun Medical Inc is recalling approximately 200,917 IV administration sets with SafeDAY components due to potential medication backflow between IV containers and blockage that may prevent line preparation.
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-0580-2026·2025-12-03
Medtronic Catalyft Spinal Implant Cages May Collapse, Risk Neurological Injury
Medtronic's Catalyft spinal interbody cages may lose height or collapse during use, which could lead to implant migration, subsidence, and neurological injury. Updated surgical techniques and instructions are being provided to mitigate this risk.
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-0617-2026·2025-12-03
Blood Administration Sets Recalled Due to Medication Backflow and Occlusion Risk
B Braun Medical Inc recalls 24,624 blood administration sets due to potential medication backflow and priming failures. The defect may allow secondary IV medications to flow backward into primary lines, affecting IV therapy delivery.
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-0637-2026·2025-12-03
Extension Set Recall: Risk of Medication Backflow in IV Administration
B Braun Medical is recalling 61,423 extension sets used with IV pumps due to potential backflow of medication and inability to prime. The recalled sets are distributed worldwide.
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-0676-2026·2025-12-03
IV Administration Set Recalled for Medication Backflow and Priming Issues
B Braun Medical Inc is recalling IV Administration Sets due to potential backflow of medication from secondary IV containers into primary containers and inability to prime properly.
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

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1526–1550 of 13414