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

4426–4450 of 39968

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-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-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-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-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-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-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-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-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-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-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-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
ModerateFDA (Devices)·Z-1301-2025·2025-03-19
GE Healthcare Revolution CT systems recalled for potential coolant leaks
GE Healthcare is recalling Revolution CT and Revolution Apex series systems due to potential coolant fluid leaks from the gantry base, which could create a slip and fall hazard.
Product
GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed
Category
Medical Device
Distribution
0 states
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
SevereFDA (Devices)·Z-1205-2025·2025-03-12
FDA Recalls VARIPULSE Bi-Directional Ablation Catheter Due to Neurovascular Events
Biosense Webster is recalling VARIPULSE Bi-Directional Ablation Catheters (REF D141201) due to an observed trend of neurovascular events. The FDA issued a Class I recall affecting approximately 497 units distributed worldwide.
Product
VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used for TRUPULSE Generator, for the treatment of drug refractory recurrent symptomat
Category
Medical Device
Distribution
10 states
SevereFDA (Devices)·Z-1254-2025·2025-03-12
Baxter Spectrum IQ Infusion System may have missing motor mounting screws
Baxter Spectrum IQ Infusion Systems may lack motor mounting screws due to a servicing defect. The FDA Class I recall affects 323 units distributed nationwide.
Product
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1245-2025·2025-03-12
Medtronic Pipeline Vantage Embolization Device Recall for Structural Deformation Risk
Medtronic is recalling approximately 18,245 unused Pipeline Vantage embolization devices due to incomplete wall apposition and braid deformation that may lead to thrombosis and serious adverse events.
Product
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1260-2025·2025-03-12
Medtronic MiniMed Insulin Pumps Recalled for Abnormal Delivery During Air Pressure Changes
Medtronic is recalling MiniMed insulin pumps that malfunction during airplane takeoff and landing due to air pressure changes. The defect can cause abnormal insulin delivery, leading to severe hypoglycemia, hyperglycemia, seizure, coma, or death.
Product
MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1294-2025·2025-03-12
Tissue Approximation System zip-ties at risk of breaking during implantation
TAS Medical is recalling Tissue Approximation System models because tissue approximation straps (zip-ties) may break before or during surgery. Undetected breaks could lead to hernia recurrence requiring additional corrective surgery.
Product
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1295-2025·2025-03-12
AURORA Surgiscope System Obturator May Break or Separate
Integra LifeSciences Corp. is recalling AURORA Surgiscope Systems (models ASX15/60 and ASX15/80) because the obturator component may break or separate during surgical use. Healthcare facilities should discontinue use and contact the manufacturer for instructions.
Product
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1258-2025·2025-03-12
MiniMed Insulin Pumps Recalled for Abnormal Delivery During Air Travel
Medtronic recalled MiniMed insulin pumps due to abnormal delivery caused by air pressure changes during airplane flights. The defect can cause severe hypoglycemia or hyperglycemia, potentially leading to seizure, coma, or death.
Product
MiniMed insulin pump, REF: 620G (MMT-1750)
Category
Medical Device
Distribution
Distributed nationwide

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4426–4450 of 39968