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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5001–5025 of 27364

  • HighFDA (Devices)·Z-2345-2024·2024-07-17

    Hemodialysis Blood Pump Rotor Spare Part Recalled for Loose Sheaves

    Fresenius Medical Care is recalling hemodialysis blood pump rotor spare parts due to reports of loose or dislodged guide sheaves. The affected model is distributed nationwide in the U.S. and Canada.

    Product
    RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2333-2024·2024-07-17

    Ophthalmic Injection Kit Recall Due to Unconfirmed Sterilization

    MICROspecialties is recalling the Synergetics I Pack Injection Kit because sterilization cannot be confirmed, potentially causing post-operative wound or injection site infections. Affected units are lot P62764979R distributed in Missouri.

    Product
    Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections Model/Catalog Number: 18060
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2279-2024·2024-07-17

    TOTAL KNEE Procedure Tray Recalled for Ethylene Oxide Sterilization Residuals

    American Contract Systems is recalling TOTAL KNEE procedure trays (Catalog BFTK01Z, lot 983241) due to ethylene oxide and ethylene chlorohydrin residuals exceeding regulatory limits for permanent-use medical devices.

    Product
    TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01Z
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2323-2024·2024-07-17

    Welch Allyn CP150 Electrocardiograph recalled for missing electromagnetic interference absorber

    Baxter Healthcare is recalling the Welch Allyn CP150 Electrocardiograph because a critical manufacturing step—installation of an electromagnetic interference absorber—was omitted. This could cause device malfunction or interference with nearby medical equipment.

    Product
    Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2290-2024·2024-07-17

    Total knee prosthesis recalled for excess ethylene oxide residuals

    American Contract Systems Inc is recalling 272 units of its TOTAL KNEE prosthesis nationwide due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component that exceed safe limits for permanent implants.

    Product
    TOTAL KNEE, ST LUKES Catalog Number: LMTK17AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2324-2024·2024-07-17

    ZOLL Powerheart G5 AED shipping film may prevent shock delivery

    ZOLL Powerheart G5 AED devices are shipped with a protective film on the front panel. If not removed before use, the film may prevent the shock button from being pressed, delaying or preventing defibrillation therapy.

    Product
    ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). Model/Catalog Number: G5S-00A G5S-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2317-2024·2024-07-17

    GE Vivid Ultrasound Scanner Displays Incorrect Patient Data

    GE Vivid ultrasound systems may display incorrect patient names and demographics due to slow DICOM response times, risking patient misidentification during imaging.

    Product
    GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2336-2024·2024-07-17

    Ophthalmic injection kit recalled due to sterilization process verification failure

    MICROspecialties is recalling 804 units of the Synergetics I Pack Injection Kit due to inability to confirm proper sterilization, which could lead to post-operative wound infections or injection site infections.

    Product
    Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection Model/Catalog Number: 18069W
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2338-2024·2024-07-17

    Endoscopic Vessel Harvesting System Recalled for C-Ring Wire Straightening

    Maquet Cardiovascular recalled 2,463 VASOVIEW HEMOPRO 2 surgical systems due to C-Ring wire straightening and component misalignment affecting tool positioning. No injuries have been reported.

    Product
    The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2312-2024·2024-07-17

    Knee Arthroscopy Kit Recalled for Elevated Sterilization Chemical Residues

    American Contract Systems Inc is recalling 60 units of the KNEE ARTHROSCOPY PACK-Procedure Kit nationwide due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component exceeding established safety limits.

    Product
    KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: WEKA15B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2335-2024·2024-07-17

    Ophthalmic injection kit recalled over sterilization confirmation failure

    MICROspecialties recalls 780 units of the Synergetics I Pack Injection Kit (Model 18069) because the company could not confirm proper sterilization, creating risk of post-operative or injection-site infections.

    Product
    Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069 Product Description:
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2277-2024·2024-07-17

    Procedure Tray Recalled for Excess Ethylene Oxide Residue

    American Contract Systems is recalling a lower extremity procedure tray (48 units) due to ethylene oxide residuals that exceed FDA safety limits for permanent exposure medical devices.

    Product
    LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2346-2024·2024-07-17

    Hemodialysis System Blood Pump Rotor Recall Due to Loose Sheaves

    Fresenius is recalling blood pump rotors in home hemodialysis systems due to loose or dislodged guide sheaves reported during clinical use. The defect could affect proper pump operation during dialysis treatment.

    Product
    RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2342-2024·2024-07-17

    Blood Pump Rotor Spare Part Recalled for Loose Guide Sheaves

    Fresenius Medical Care recalls a blood pump rotor spare part used in dialysis systems in Canada due to reports of loose or dislodged guide sheaves after use. No injuries have been reported.

    Product
    191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2305-2024·2024-07-17

    Hip Procedure Kit Recalled for Excessive Ethylene Oxide Sterilization Residuals

    American Contract Systems Inc is recalling 393 units of the TPK Anterior Hip Pack nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for permanent exposure medical devices.

    Product
    TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2331-2024·2024-07-17

    AURORA Surgiscope System Recalled for Potential Sheath Damage

    Integra LifeSciences is recalling 14 units of the AURORA Surgiscope System due to potential sheath damage that could cause tissue damage or internal bleeding.

    Product
    AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2325-2024·2024-07-17

    Kosmos iOS Ultrasound Software Update Due to Measurement Accuracy Bug

    Echonous Inc is recalling Kosmos ultrasound software for iOS due to a bug causing inaccurate measurements in DICOM exports, potentially leading to incorrect diagnoses.

    Product
    Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-2299-2024·2024-07-17

    TOTAL KNEE-Procedure Kit Recalled Due to Ethylene Oxide Residuals

    American Contract Systems is recalling 976 units of TOTAL KNEE-Procedure Kits nationwide due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component that exceed safe exposure limits for medical devices.

    Product
    TOTAL KNEE-Procedure Kit Catalog Number: SFTK54B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2330-2024·2024-07-17

    Presource Neurological Surgical Kits Recalled for Syringe Design Defect

    Cardinal Health is recalling Presource neurological surgical kits containing defectively designed syringes that may cause inaccurate dosing or device leakage. The recall affects 13,487 kits distributed nationwide.

    Product
    Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1; 3) Neurological Tray, Catalog Number SAN29NRCC2; 4) Neurological Tray, Catalog Number SAN29NRCC3; 5) Neurological Tray, Catalog Number SAN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2248-2024·2024-07-10

    Megadyne MEGA 2000 Patient Return Electrode recalled for burn risk

    Megadyne is recalling the MEGA 2000 Patient Return Electrode due to identified potential risk of patient burns. Use is now restricted to patients aged 12 or older.

    Product
    Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode Model/Catalog Number: 0800 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega 2000, Adult, For Patients Weighing over 25lbs. (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2249-2024·2024-07-10

    MEGADYNE MEGA SOFT Reusable Patient Return Electrode Recalled for Burn Risk

    Megadyne Medical recalls MEGA SOFT reusable patient return electrodes (Model 0830) due to identified burn risk. Use is restricted to patients aged 12 and older.

    Product
    Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catalog Number: 0830 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Single Cord, Adult, For
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2250-2024·2024-07-10

    Reusable Patient Return Electrode Recalled Due to Burn Risk

    MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrodes are recalled due to an identified risk of patient burns. Use should be restricted to patients aged 12 or older.

    Product
    Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Model/Catalog Number: 0835 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Dual Cord, Adu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2246-2024·2024-07-10

    Portable X-Ray Cart Positioning Arm Bolt May Come Loose and Fall

    First Source Inc is recalling the First Source Vision M portable X-ray cart because the bolt securing the positioning arm to the gas spring may come loose and fall onto a patient.

    Product
    First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2244-2024·2024-07-10

    MicroPort Knee Implant Recall: Wrong Size Component in Packaging

    MicroPort's EVOLUTION MP knee implants recalled due to one confirmed case where a Size 3 left-side component was packaged in a Size 4 right-side box. No injuries reported; distribution is limited to China with no U.S. inventory.

    Product
    EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2239-2024·2024-07-10

    Avalon Ultrasound Transducers Recalled for Inaccurate Fetal Heart Rate Monitoring

    Philips is recalling Avalon ultrasound transducers used for monitoring fetal heart rate. The device may produce inaccurate measurements when monitoring multiple fetuses, potentially delaying detection of fetal distress.

    Product
    Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
    Category
    Medical Device
    Distribution
    Distributed nationwide