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

3601–3625 of 13449

HighFDA (Devices)·Z-1320-2025·2025-03-19
ZOLL Powerheart G5 AED may fail self-test in extreme temperatures or humidity
ZOLL is recalling 73 Powerheart G5 AED units that may fail their internal self-test when exposed to extreme temperatures or humidity. Affected devices could be unreliable in emergencies.
Product
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat i
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1325-2025·2025-03-19
Da Vinci 5 surgical console foot pedals recalled for spring failure
Intuitive Surgical has recalled 439 Da Vinci 5 surgical console foot tray pedals due to spring failures that can cause pedals to remain pressed and interfere with normal surgical robot operation.
Product
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional details. Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1300-2025·2025-03-19
GE Healthcare Revolution CT systems coolant leak creates slipping hazard
Certain GE Healthcare Revolution CT and Apex series systems may leak coolant fluid near the gantry base, creating a potential slip-fall hazard if left unnoticed.
Product
GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1309-2025·2025-03-19
Aesculap Hemostatic Forceps Recalled Due to Clamp Breakage
Aesculap Inc is recalling 917,965 units of nonsterile hemostatic forceps across multiple models because the clamps can break when used beyond design specifications. No injuries have been reported.
Product
Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps 85MM; (2) REF BH104R, Hartmann Mosquito FCSDEL STR 100MM; (3) REF BH105R, Hartmann Mosquito FCPSDELCVD100MM; (4) REF BH108R, Micro-Halsted Forceps DEL STR125MM; (5) REF BH109R, Micro-Hals
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1324-2025·2025-03-19
Philips Spectral CT on Rails software recall due to scanning and movement issues
Philips is recalling one unit of Spectral CT on Rails software version 5.1.0 due to multiple software problems causing scanning issues, image errors, and unintended device movement.
Product
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1330-2025·2025-03-19
Vista Brite Tip Guiding Catheter Manufactured at Incorrect Length
Cordis US Corp is recalling Vista Brite Tip guiding catheters manufactured at incorrect length. The defect may affect proper catheter placement during interventional or diagnostic vascular procedures.
Product
Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1319-2025·2025-03-19
ZOLL Powerheart G5 AED May Fail Self-Test in Extreme Environmental Conditions
ZOLL is recalling certain Powerheart G5 AED models that may fail their self-test function when exposed to extreme temperature or humidity. Affected devices might not function properly in emergencies.
Product
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C, (9) G5A-41C, (10) G5A-85C, (11) G5A-90C (12) G5A-80-L; Software Version: NA Product Description: The
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1303-2025·2025-03-19
GE Healthcare CT Scanner Systems Recalled Due to Coolant Leak Risk
GE Healthcare is recalling 21 Revolution CT and Revolution Apex series CT systems due to potential coolant fluid leaks near the gantry base. The leaking fluid poses a slip-and-fall hazard if not cleaned up promptly.
Product
GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1299-2025·2025-03-19
GE Healthcare CT Systems May Leak Coolant Fluid on Floor
GE Healthcare Revolution CT and Apex series systems can leak coolant fluid onto the floor near the gantry, creating a slip and fall hazard. The blue-colored fluid is non-corrosive and not hot, but poses injury risk if not noticed.
Product
GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1326-2025·2025-03-19
Beckman Coulter DxI 9000 Analyzer wash wheel mixer defect may prevent operation
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to a mechanical defect in the wash wheel mixer that may prevent the device from operating properly. The defect can cause test delays or cancellation.
Product
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1312-2025·2025-03-19
Aesculap hemostatic forceps recalled due to clamp breakage
Aesculap is recalling 47,078 surgical forceps designed to control bleeding. The devices' clamps break when used outside design parameters, potentially compromising their effectiveness.
Product
Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952R, Negus Tonsil Forceps X-HVY-CVD190MM; (3) REF BH957R, Schnidt Tonsil Forceps SLT-CVD185MM; (4) REF BH959R, Schnidt Tonsil Forceps CVD 185MM; (5) REF BH961R,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1315-2025·2025-03-19
Cartilage Transplant System Disposable Kits Recalled for Missing Component
DePuy Mitek is recalling COR Disposable Kit cartilage transplant systems because some units lack the pin in the graft loader component. The manufacturing defect may prevent proper device function during surgical use.
Product
COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1329-2025·2025-03-19
Z1 Femoral Hip System Recalled Over Stem Inserter Design Issue
Zimmer, Inc. is recalling 35 units of the Z1 Femoral Hip System due to a potential design issue with the Z1 Offset Stem Inserter that could cause fracturing of the distal tip.
Product
Z1 Femoral Hip System, Product Number 611777612
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1321-2025·2025-03-19
ZOLL Powerheart G5 AED devices may fail self-test in extreme environments
ZOLL is recalling Powerheart G5 AED devices that may fail their self-test when exposed to extreme temperature or humidity, potentially affecting proper device operation.
Product
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrilla
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1322-2025·2025-03-19
ZOLL Powerheart G5 AED Self-Test May Fail Under Extreme Environmental Conditions
ZOLL is recalling certain Powerheart G5 AED units that may fail their self-test when exposed to extreme temperatures or humidity. The affected devices could fail to function properly in emergencies.
Product
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9) G5S-80-L (10) G5S-90A; Software Version: NA Product Description: The Powerheart G5 automa
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1310-2025·2025-03-19
Multiple Aesculap Surgical Forceps Models Recalled for Clamp Breakage
Aesculap Inc is recalling 93,714 hemostatic forceps across 83 models due to clamp breakage that occurs when forceps are used in ways not covered by the design.
Product
Numerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig Artery Forceps CVD.190MM; (2) REF BH304R, Pean Artery Forceps Straight 140MM; (3) REF BH813R, Artery Forceps Curved 250MM; (4) REF BJ016R, Diss.A.Ligat.Forceps S-Shaped CVD.210MM; (5) REF BJ020R, Ove
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1307-2025·2025-03-19
CardiFocus Heartlight X3 Cardiac Catheter Sterile Barrier Damage Recall
CardioFocus is recalling 833 units of CardiFocus Heartlight X3 cardiac catheters due to potential damage to the sterile barrier pouch that could compromise product sterility. Affected units were distributed worldwide.
Product
CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an Electrophysiology or Catheterization Laboratory Model: 18-5000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1327-2025·2025-03-19
Blood Pump Recalled for Potential Fluid Leakage During Clinical Use
Spectrum Medical is recalling Quantum Perfusion blood pumps due to potential fluid leakage during priming or clinical use. The issue affects approximately 1,487 units distributed nationwide.
Product
Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-VT Software Version: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1311-2025·2025-03-19
Multiple hemostatic forceps models recalled due to clamp breakage risk
Aesculap is recalling 1,147 hemostatic forceps due to clamp breakage risk when used beyond design specifications. Units were distributed nationwide and internationally to healthcare providers.
Product
Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD 215MM; (2) REF FB459R, Glover ATR.CLAMP CVD 245MM; (3) REF FB461R, Glover ATR.CLAMP 195MM; (4) REF FB462R, Glover ATR.CLAMP 210MM; (5) REF FB469R, Leland-Jones Peripheral CLMPSTR 195MM;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1302-2025·2025-03-19
GE Revolution CT Systems Potential Coolant Leak Slip-and-Fall Risk
GE Healthcare Revolution CT systems may leak glycol coolant near the gantry base. While the non-toxic fluid poses no chemical hazard, it creates a slip-and-fall risk if not noticed and cleaned.
Product
GE Healthcare Revolution CT, System, X-ray, Tomography, Computed
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1314-2025·2025-03-19
COR Disposable Cartilage Transplant Kit recalled for missing graft loader pin
DePuy Mitek's COR Disposable Cartilage Transplant System is being recalled because some units are missing a pin in the graft loader component, which could affect surgical function.
Product
COR Disposable Kit, 8 mm. Cartilage Transplant System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1328-2025·2025-03-19
Stryker CinchLock anchor recalled due to pullwire breakage
Stryker is recalling its CinchLock Flex Knotless Anchor due to an increase in pullwire breakage complaints. The broken pullwire may remain in the implant body after deployment.
Product
Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1323-2025·2025-03-19
ZOLL Powerheart G5 AED Devices Recalled for Self-Test Failure Risk
ZOLL is recalling 8,744 Powerheart G5 AED units that may fail their self-test if exposed to extreme temperatures or humidity, potentially masking device malfunctions.
Product
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrilla
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1298-2025·2025-03-19
GE Revolution CT and Apex systems coolant fluid leak hazard
GE Healthcare Revolution CT and Apex series imaging systems may leak blue coolant fluid near the gantry base, creating a potential slip and fall hazard. Approximately 250 units have been distributed worldwide.
Product
GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1297-2025·2025-03-19
GE Healthcare Revolution CT Systems: Coolant Fluid Leak Creates Slip Hazard
GE Healthcare Revolution Apex and Revolution CT series systems may leak coolant fluid onto the floor near the gantry. The blue-colored, non-toxic fluid poses a slip and fall hazard if not noticed.
Product
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
Category
Medical Device
Distribution
0 states

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3601–3625 of 13449