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

5926–5950 of 13666

HighFDA (Devices)·Z-2395-2024·2024-07-24
Infusomat SPACE Pump IV Set Recalled Due to Backcheck Valve Malfunction
B. Braun Medical is recalling the Infusomat SPACE IV pump set (Model 480255) due to potential backcheck valve malfunction that could allow medication to flow backward between IV containers, potentially causing adverse drug reactions or loss of medication.
Product
Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 480255
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2361-2024·2024-07-24
Abbott Proclaim 7 Implantable Pulse Generator May Reach End-of-Service Sooner Than Labeled
Abbott is recalling 569 units of the Proclaim 7 implantable pulse generator because the device may reach end-of-service sooner than indicated in labeling. All affected units were distributed worldwide.
Product
Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2349-2024·2024-07-24
Cascade IOMAX Cortical Module recalled for defective circuit board
Cascade IOMAX Cortical Module devices are recalled due to a defective printed circuit board that may cause unintended electrical stimulation. Affected units were distributed in the U.S. and internationally.
Product
Cascade IOMAX Cortical Module, REF: 190296-200
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2390-2024·2024-07-24
Infusion Pump Set Recalled Due to Valve Malfunction Risk
B. Braun's Infusomat UNIV. 60 infusion pump sets are recalled due to backcheck valve malfunction that may cause medication backflow from secondary to primary IV bags, risking adverse drug reactions or medication loss.
Product
Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363423
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2356-2024·2024-07-24
Cochlear implant devices recalled for potential internal electronics substrate defect
MED-EL Mi1250 SYNCHRONY 2 cochlear implants may have cracks in their internal electronics substrate that could cause device failure. Seven devices distributed to Durham, North Carolina are affected.
Product
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2351-2024·2024-07-24
BD Multitest 6-Color TBNK Reagent Contamination May Cause Erroneous Results
BD Multitest 6-Color TBNK flow cytometry reagent contains contaminated antibodies that may produce erroneous or delayed test results, potentially impacting clinical decisions.
Product
BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166; BD Multitest 6-Color TBNK, IVD, REF: 662967; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes IVD, REF: 662995. BD Multitest" 6-Color TBNK reagent wit
Category
Medical Device
Distribution
34 states
HighFDA (Devices)·Z-2348-2024·2024-07-24
Agilis NxT Steerable Introducer Recalled for Dilators Too Short
St. Jude Medical is recalling 129 units of the Agilis NxT Steerable Introducer due to dilators that are too short and will not extend outside the introducer sheath. The defect may prevent proper device function.
Product
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2367-2024·2024-07-24
Abbott Proclaim DRG implantable pulse generator service life shorter than labeled
Abbott is recalling 21,843 Proclaim DRG implantable pulse generators because the duration between the device's elective replacement indicator and end of service may be shorter than stated in product labeling.
Product
Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2406-2024·2024-07-24
Surgical Hemostatic Device Recalled for Compromised Sterile Barrier
Ethicon is recalling SURGICEL FIBRILLAR hemostatic pads due to torn foil pouches that compromise the sterile barrier, traced to a specific packaging machine defect.
Product
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2405-2024·2024-07-24
Zimmer Tourniquet Cuff Recalled Due to Incorrect Port Configuration Labeling
Stryker is recalling 90 units of Zimmer Tourniquet Cuff 30" because packaging labels them as dual port single bladder, but they actually contain a single port single bladder configuration.
Product
REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2363-2024·2024-07-24
Abbott Proclaim 7 Pulse Generator Battery Life Shorter Than Labeled
Abbott is recalling approximately 457 Proclaim 7 Implantable Pulse Generators because the battery may reach end of service sooner than indicated in labeling. Patients may require unexpected device replacement.
Product
Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2381-2024·2024-07-24
Infusion pump set backcheck valve malfunction may prevent medication delivery
B. Braun Medical is recalling an infusion pump set due to potential backcheck valve malfunction that could cause medication to flow backward into IV containers and prevent proper medication administration. The recall affects 3,624 units distributed worldwide.
Product
Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362050
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2252-2024·2024-07-17
Medical Device Recall: Bausch+Lomb Intravitreal Injection Kit Unvalidated Sterilization
Synergetics Inc is recalling Bausch+Lomb I-PACK Intravitreal Injection Kits because sterilization certificates could not be validated by the supplier. The FDA classified this as Class I.
Product
BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2254-2024·2024-07-17
Intravitreal Injection Kit Recalled for Unvalidated Sterilization Certificates
Synergetics Inc is recalling 35 units of the BAUSCH+LOMB I-PACK Intravitreal Injection Kit because sterilization certificates could not be validated, creating an infection risk.
Product
BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2251-2024·2024-07-17
Bausch+Lomb I-PACK Injection Kit Recalled for Unvalidated Sterilization
Synergetics Inc is recalling the Bausch+Lomb I-PACK Injection Kit nationwide because sterilization certificates could not be validated by the supplier. The unvalidated sterilization of this eye injection device poses a potential infection risk.
Product
BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2313-2024·2024-07-17
Baxter VidiaPort and Trulight surgical lights recalled for thermal burn risk
Baxter Healthcare Corporation is recalling VidiaPort and Trulight surgical light systems due to customer reports of thermal skin injuries. Approximately 275 units were distributed worldwide.
Product
VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling Duo Surgical Lights); c) 4028310 (Ceiling Trio Surgical Lights)
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2314-2024·2024-07-17
Baxter Trulight Surgical Lights Recalled for Thermal Skin Injuries
Baxter Healthcare Corporation recalled Trulight 5000/3000 Surgical Light systems due to customer reports of thermal skin injuries. The urgent medical device correction affects models 4038210 and 4038310 distributed worldwide.
Product
Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2315-2024·2024-07-17
Baxter iLED 7 surgical lights recalled due to thermal burn risk
Baxter Healthcare is recalling iLED 7 surgical lights due to customer reports of thermal skin injuries. The recall affects approximately 6,243 units distributed worldwide.
Product
iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Light); c) 4068140 (Pendant Surgical Light); d) 4068210 (Ceiling Duo Surgical Lights); e) 4068310 (Ceiling Trio Surgical Lights); f) 4068410 (Ceiling Quad
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2253-2024·2024-07-17
BAUSCH+LOMB I-PACK Injection Kit Recalled Due to Sterilization Validation Failure
FDA has recalled 116 units of BAUSCH+LOMB I-PACK Injection Kits because sterilization certificates could not be validated by the supplier, creating potential infection risk for patients receiving intravitreal eye injections.
Product
BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injection (eye)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2294-2024·2024-07-17
Knee Procedure Kit Recalled for Elevated Chemical Residuals
American Contract Systems Inc is recalling 26 TOTAL KNEE Procedure Kits due to excess ethylene oxide and ethylene chlorohydrin residues on the cast padding component that exceed safe exposure limits.
Product
TOTAL KNEE -Procedure Kit Catalog Number: QPTK95B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2318-2024·2024-07-17
Dental abutment recall due to incorrect product packaging and labeling
Preat Corp recalled 7 units of 9006767 Astra EV 4.8mm Milled Titanium Abutments due to incorrect products being packaged and labeled. Affected units were distributed in California, Missouri, and Nevada.
Product
9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2328-2024·2024-07-17
Cardinal Health Cardiac Catheterization Kits Recalled for Potential Syringe Design Defect
Cardinal Health is recalling Presource Cardiac Catheterization Kits because the included syringes may have design defects that could cause inaccurate dosing or leakage, creating a risk of patient harm.
Product
Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB; 2) Cardiac Catheterization Kit, Catalog Number SAN73CCV10; 3) Cardiac Catheterization Kit, Catalog Number SAN73CCV11; 4) Cardiac Catheterization Kit, Catalog Number SAN73CCV1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2279-2024·2024-07-17
TOTAL KNEE Procedure Tray Recalled for Ethylene Oxide Sterilization Residuals
American Contract Systems is recalling TOTAL KNEE procedure trays (Catalog BFTK01Z, lot 983241) due to ethylene oxide and ethylene chlorohydrin residuals exceeding regulatory limits for permanent-use medical devices.
Product
TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01Z
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2278-2024·2024-07-17
Knee surgery procedure tray recalled for chemical contamination
American Contract Systems is recalling TOTAL KNEE procedure trays (Catalog Number BFTK01AA) due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component that exceed acceptable regulatory limits.
Product
TOTAL KNEE - 247546 - Procedure tray Catalog Number: BFTK01AA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2306-2024·2024-07-17
Surgical Procedure Kit Recalled for Ethylene Oxide Residual Contamination
American Contract Systems Inc is recalling the ACL PACK Surgical Procedure Kit due to elevated ethylene oxide and ethylene chlorohydrin residuals that exceed regulatory limits for permanent-contact medical devices.
Product
ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA
Category
Medical Device
Distribution
Distributed nationwide

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5926–5950 of 13666