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

3026–3050 of 27346

HighFDA (Devices)·Z-1308-2025·2025-03-19
Hemostatic Forceps Recalled Due to Clamp Breakage in Surgical Use
Aesculap Inc is recalling 19,979 hemostatic forceps across 18 models because clamps can break when instruments are used outside of design specifications.
Product
Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJ501R, Phaneuf Hysterectomy Forceps ANG 205MM; (3) REF BJ511R, Holzbach Hyst Forceps CVD245MM; (4) REF BJ520R, Heaney Hyst Forceps Grooved 205MM; (5) REF BJ52
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1313-2025·2025-03-19
TruScan Body dental scanner recalled due to scanning malfunction
TruAbutment Inc. recalls 61 units of the TruScan Body dental scanner (CN38-SB) due to defects that may prevent proper or accurate scanning.
Product
Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software Version: N/A
Category
Medical Device
Distribution
16 states
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-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-1318-2025·2025-03-19
ZOLL Powerheart G5 AED may fail self-test in extreme environments
ZOLL is recalling certain Powerheart G5 automated external defibrillators (AED) due to the potential for devices to fail their self-test when exposed to extreme temperatures or humidity.
Product
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80C, (2) G5A-80C-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as
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-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-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
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-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-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-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-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-1317-2025·2025-03-19
ZOLL Powerheart G5 AED May Fail Self-Test After Environmental Exposure
ZOLL Powerheart G5 AED devices may fail their self-test if exposed to extreme temperatures or humidity. Approximately 56,981 units are being recalled nationwide and internationally.
Product
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-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-1316-2025·2025-03-19
ZOLL Powerheart G5 AED May Fail Self-Test in Extreme Conditions
The ZOLL Powerheart G5 automated external defibrillator may fail its self-test after prolonged exposure to extreme temperatures or humidity levels. This could prevent proper device functioning in an emergency.
Product
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6) G5A-80A, (7) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1244-2025·2025-03-12
Rotarex Atherectomy Catheter Recalled for Helix Fracture Risk
Bard is recalling Rotarex Atherectomy System catheters due to potential helix fracture or breakage that could cause vessel injury and severe bleeding. Updated instructions are being distributed to clarify procedural steps to reduce this risk.
Product
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1257-2025·2025-03-12
Insulin pump recall: Medtronic Paradigm models malfunction during airplane flight
Medtronic MiniMed's Paradigm insulin pumps can malfunction during airplane flight due to air pressure changes, potentially causing dangerously high or low blood sugar levels that could be fatal.
Product
Paradigm insulin pump, REF: MMT-754
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1263-2025·2025-03-12
Insulin Pump Recalled for Abnormal Delivery During Flight Pressure Changes
Medtronic MiniMed 720G insulin pumps may malfunction during airplane travel due to air pressure changes, causing abnormal insulin doses that can lead to severe low or high blood sugar emergencies.
Product
MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1246-2025·2025-03-12
Medtronic Pipeline Vantage device recall: deformation may cause blood clots
The Pipeline Vantage Embolization Device may malfunction, with the braid deforming or not positioning correctly, potentially causing blood clots. Approximately 7,820 units are affected worldwide.
Product
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1253-2025·2025-03-12
Baxter Sigma Spectrum Infusion System Recalled for Missing Mounting Screws
Baxter Healthcare is recalling 66 units of Sigma Spectrum Infusion System (V6) due to potential missing motor mounting screws that may have occurred during servicing. Missing screws could affect the device's operation.
Product
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
Category
Medical Device
Distribution
Distributed nationwide

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3026–3050 of 27346