The Recall Desk

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.

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3676–3700 of 13543

  • 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-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-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-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-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-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-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
  • 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-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-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-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-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-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-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-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-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-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
  • 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-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
  • 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
  • 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-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-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
  • 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