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.

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2526–2550 of 13381

  • ModerateFDA (Devices)·Z-2345-2025·2025-08-27

    Dynex Agility Sample Tips Misidentified Due to Incorrect Internal Labeling

    Dynex Agility Sample Tips (Model 67910) have incorrect internal labeling that causes the instrument to misidentify them as a different tip type. This incompatibility prevents use and delays patient test results.

    Product
    Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2337-2025·2025-08-27

    Clearview Strep A Exact II Diagnostic Kit Distributed to Unlicensed Facilities

    Due to an inventory system error, Clearview Strep A Exact II diagnostic kits were shipped to facilities without the required license to purchase them.

    Product
    Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2290-2025·2025-08-20

    HeartMate Mobile Power Unit AC Power Cord misalignment recall

    Thoratec is recalling HeartMate 3 Mobile Power Unit AC Power Cords (Model 107760) with a misaligned V-Lock feature that may prevent proper engagement and cause unintended power disconnection.

    Product
    Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device desi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2173-2025·2025-08-20

    Baxter Novum IQ Pump Underinfusion and Overinfusion Risk

    Baxter Novum IQ Large Volume Pumps may infuse medication at incorrect rates during flow-rate transitions or due to improper tubing loading. The 36,705 affected units worldwide should be checked per safety instructions.

    Product
    Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2181-2025·2025-08-20

    Ambu SPUR II Resuscitators Recalled for Blocked Manometer Port

    Ambu Inc. is recalling 87,156 SPUR II Resuscitator units because the manometer port may become blocked, rendering the manometer non-functional. The recall affects models distributed nationwide and in Canada.

    Product
    Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 523611051 3 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611057 4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2228-2025·2025-08-20

    DreamStation Auto BiPAP Ventilators Recalled Due to Programming Error

    Philips is recalling 8 DreamStation Auto BiPAP ventilators due to a programming error that may result in incorrect device configuration. Affected units are distributed nationwide and in France.

    Product
    DreamStation Auto BiPAP. Non-Continuous Ventilator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2229-2025·2025-08-20

    DreamStation Auto Non-Continuous Ventilator Recalled for Programming Error

    Philips Respironics is recalling the DreamStation Auto Non-Continuous Ventilator due to a programming error that may result in incorrect device configuration affecting 28 units.

    Product
    DreamStation Auto. Non-Continuous Ventilator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2280-2025·2025-08-20

    Cannulated Fenestrated Polyaxial Screws Recalled for Incorrect Labeling

    SPINEART SA is recalling certain Cannulated Fenestrated Polyaxial Screws (PERLA TL MIS) due to incorrect labeling. The affected devices were distributed in Florida, Kentucky, and California.

    Product
    Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2285-2025·2025-08-20

    Knee implants recalled for incorrect size and side labeling

    Encore Medical is recalling 18 EMPOWR 3D knee implants due to incorrect labeling showing wrong size and/or side. Mislabeled implants could result in the wrong device being used during surgery.

    Product
    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2287-2025·2025-08-20

    Sparrow Ascent Patient Controller Recalled for Cable Disconnect

    Spark Biomedical is recalling the Sparrow Ascent Patient Controller neurostimulator due to a manufacturing defect that causes cable disconnect errors and interrupts stimulation output. The recall affects 78 units distributed nationwide.

    Product
    Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2300-2025·2025-08-20

    GE Medical MRI Systems Caster Lock Maintenance Check Recall

    GE HealthCare is recalling certain MRI systems because planned maintenance checks on caster lock functionality may not have been performed on some units. Approximately 280 systems are affected, with worldwide distribution.

    Product
    GE Signa Voyager, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2288-2025·2025-08-20

    Hip Prosthesis Labeling Has Inconsistent Size Terminology and Color Coding

    Waldemar Link is recalling 46 units of Prosthesis Head B due to inconsistent size terminology and color coding on labeling, which could lead to confusion during product selection.

    Product
    Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2311-2025·2025-08-20

    GE SIGNA Voyager AIR MRI systems may have unverified caster locks

    GE HealthCare is recalling SIGNA Voyager AIR MRI systems in China where planned maintenance checks on patient table caster locks may not have been performed. Faulty locks could allow the patient table to move unexpectedly during imaging.

    Product
    GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2320-2025·2025-08-20

    GE SIGNA PET/MR AIR Plus: Caster lock maintenance check may not have been performed

    GE HealthCare recalled certain MR imaging systems because the planned maintenance steps to check caster lock functionality on the patient table may not have been performed. Affected systems include SIGNA PET/MR AIR Plus (China Only).

    Product
    GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2299-2025·2025-08-20

    GE Recalls MR Imaging Systems Due to Unverified Caster Locks

    GE HealthCare is recalling certain MR imaging systems because planned maintenance steps to verify caster lock functionality may not have been performed. Worldwide distribution includes 760 units.

    Product
    GE Signa Artist, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2314-2025·2025-08-20

    GE MR Systems Patient Table Caster Lock Maintenance Recall

    GE HealthCare is recalling certain MR imaging systems because planned maintenance steps to verify caster lock functionality on the patient table may not have been completed.

    Product
    GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2298-2025·2025-08-20

    Ultra IABP Catheter Kit recalled for unapproved indications and inconsistent instructions

    Insightra Medical is recalling the Ultra IABP Catheter Kit because the device contains indications for use and compatibility claims that were not reviewed and approved by the FDA, and the instructions for use do not match product training.

    Product
    Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20 Software Version: Not applicable Product Description: The Insightra Ultra IABP Catheter Kit is a 7 French catheter available wi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2313-2025·2025-08-20

    GE HealthCare MRI Systems Caster Lock Maintenance Verification Recall

    GE HealthCare recalled certain MRI systems after discovering that planned maintenance checks to verify caster lock functionality on patient tables may not have been performed on some units.

    Product
    GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2282-2025·2025-08-20

    Carefree Robotic/Laparoscopy Kittner Rolls Gauze recalled for contamination and incorrect quantity

    Carefree Surgical Specialties is recalling Robotic/Laparoscopy Kittner Rolls Gauze (Lot 1645) due to biological foreign matter contamination and incorrect quantity in sterile packaging, affecting 500 units distributed nationwide.

    Product
    Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2286-2025·2025-08-20

    EMPOWR 3D Knee Implants Recalled for Incorrect Size and Side Labeling

    Encore Medical recalled 40 EMPOWR 3D knee implants because labels incorrectly specified implant size and/or side. The affected implants were distributed nationwide and patients should contact their healthcare provider if concerned.

    Product
    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2273-2025·2025-08-20

    [pending] Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery

    Pending LLM rewrite. Source: FDA_DEVICE Z-2273-2025.

    Product
    Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers: H7493915010240 CAROTID WALLSTENT MONORAIL 10.0-24; H7493915010310 CAROTID WALLSTENT MONORAIL 10.0-31; H749391506220 CAROTID WALLSTENT MONORAIL
    Category
    Medical Device
    Distribution
    Distributed nationwide