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

4901–4925 of 27375

HighFDA (Devices)·Z-2394-2024·2024-07-24
Infusomat SPACE Pump IV Sets Recalled for Backcheck Valve Malfunction
B. Braun's Infusomat SPACE Pump IV sets are recalled due to a potential backcheck valve malfunction that could cause medication backflow and inability to prime. The defect affects approximately 109,464 units distributed in the US and Canada.
Product
Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 480254
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2391-2024·2024-07-24
Infusomat UNIV. 15 IV Pump Set Recalled for Backflow Hazard
B. Braun Medical is recalling 32,752 units of the Infusomat UNIV. 15 DR pump tubing set due to potential backcheck valve malfunction that could cause medication backflow between IV containers and medication loss.
Product
Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363424
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2389-2024·2024-07-24
Infusion Pump Component Valve Malfunction May Cause Medication Backflow
B. Braun's Infusomat infusion pump component can malfunction, causing medication to flow backward from secondary IV lines into primary lines, potentially resulting in improper medication delivery and patient harm.
Product
Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363422
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2397-2024·2024-07-24
IV Infusion Pump Set Valve May Cause Dangerous Medication Backflow
B. Braun's Infusomat pump sets may have faulty backcheck valves causing medication to backflow between IV bags, risking reduced medication delivery and adverse reactions. All units distributed worldwide after August 2023 are affected.
Product
Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2399-2024·2024-07-24
IV Infusion Pump Sets Recalled for Backcheck Valve Malfunction
B. Braun is recalling Infusomat IV infusion pump sets due to potential backcheck valve malfunction that can cause medication to flow backward between IV containers and prevent proper medication delivery.
Product
Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number 490102
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2364-2024·2024-07-24
Abbott Proclaim Plus 5 Pulse Generator Battery Life Shorter Than Labeled
Abbott is recalling 8,401 units of the Proclaim Plus 5 Implantable Pulse Generator because the battery may reach end-of-service sooner than the product labeling indicates.
Product
Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2358-2024·2024-07-24
Abbott Proclaim XR 5 Implantable Pulse Generator Battery Labeling Error
Abbott Proclaim XR 5 implantable pulse generators may reach end of service sooner than product labeling indicates, affecting approximately 83,511 units worldwide. Patients should contact their healthcare provider for guidance on device monitoring and replacement planning.
Product
Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2384-2024·2024-07-24
IV Pump Sets Recalled for Potential Backcheck Valve Malfunction
B. Braun Infusomat SPACE IV pump sets may experience backcheck valve malfunction, causing medication backflow between containers and preventing proper IV line priming. This could result in adverse drug reactions, incorrect medication doses, or medication loss.
Product
Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362432
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2365-2024·2024-07-24
Abbott Proclaim Plus 5 Pulse Generator May Have Shorter Service Life Than Labeled
Abbott is recalling 38 Proclaim Plus 5 Implantable Pulse Generators because they may reach end of service sooner than product labeling indicates, potentially affecting pain management therapy for affected patients.
Product
Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2368-2024·2024-07-24
Abbott Recalls Proclaim 7 Elite Pulse Generator for Battery Life Discrepancy
Abbott Medical is recalling Proclaim 7 Elite Implantable Pulse Generators because the device may reach end of service sooner than indicated in the product labeling. Patients should consult their healthcare provider.
Product
Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
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-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-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-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-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-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
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
HighFDA (Devices)·Z-2281-2024·2024-07-17
Arthroscopy Procedure Tray Recalled for Sterilant Residual Contamination
American Contract Systems Inc is recalling 272 units of the ARTHROSCOPY SUP JOI PACK Procedure Tray because sterilant residuals in the cast padding exceeded safe limits for permanent implant use.
Product
ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17C
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-2295-2024·2024-07-17
Procedure Kit Recalled for Excess Ethylene Oxide Residue in Cast Padding
American Contract Systems Inc is recalling 36 units of Hand Pack procedure kits due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component exceeding regulatory limits.
Product
HAND PACK 297829--Procedure Kit Catalog Number: RGHN04I
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2341-2024·2024-07-17
Blood Pump Rotor Guide Sheaves May Loosen in Home Hemodialysis System
Fresenius is recalling Blood Pump Rotor components in 2008K@HOME hemodialysis systems due to reports of loose or dislodged guide sheaves that could affect pump function. Affected patients should contact their clinic to verify involvement.
Product
190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2289-2024·2024-07-17
Cast Padding Component Recalled for Excess Ethylene Oxide Residuals
American Contract Systems Inc is recalling ACL cast padding components due to ethylene oxide/ethylene chlorohydrin residuals exceeding safe limits for permanent skin contact devices. Affected product distributed nationwide.
Product
ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2285-2024·2024-07-17
Foot-Ankle Procedure Tray Recalled for Excessive Sterilization Residue
American Contract Systems Inc is recalling 107 units of FOOT ANKLE-LF Procedure tray distributed nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits for permanent-implant devices.
Product
FOOT ANKLE-LF Procedure tray Catalog Number:CCFA51B
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-2276-2024·2024-07-17
American Contract Systems Surgical Trays Recalled for Ethylene Oxide Residuals
American Contract Systems is recalling MAJOR KNEE surgical procedure trays due to excessive ethylene oxide and ethylene chlorohydrin residuals from sterilization that exceed safety limits for permanent exposure devices.
Product
MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23B
Category
Medical Device
Distribution
Distributed nationwide

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4901–4925 of 27375