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.

Filters

Agency

Category

Minimum severity

Clear filters

6001–6025 of 13666

  • 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-2344-2024·2024-07-17

    Blood Pump Rotor Spare Part Recall Due to Loose Guide Sheaves

    Fresenius is recalling 17 Blood Pump Rotor spare parts nationwide due to loose or dislodged guide sheaves that develop after use. The affected rotor components are used in K@HOME dialysis machines.

    Product
    RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    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-2297-2024·2024-07-17

    Total Knee Procedure Kit Recalled for Excess Ethylene Oxide Residue

    American Contract Systems Inc is recalling a knee surgery procedure kit (24 units, Lot 939241) due to ethylene oxide sterilization residues in the cast padding exceeding safety exposure limits for permanent-implant devices.

    Product
    TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2291-2024·2024-07-17

    Knee Arthroscopy Pack Recalled for Excess Sterilization Residues

    American Contract Systems Inc. is recalling 84 knee arthroscopy packs (Catalog Number MEKA12R) distributed nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for permanent exposure medical devices.

    Product
    KNEE ARTHROSCOPY PACK Catalog Number: MEKA12R
    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
  • 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-2311-2024·2024-07-17

    Hand Pack Procedure Kit recalled for excess ethylene oxide residuals

    American Contract Systems Inc is recalling the HAND PACK-Procedure Kit (catalog WEHD16C) due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits.

    Product
    HAND PACK-Procedure Kit Catalog Number: WEHD16C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2343-2024·2024-07-17

    Blood Pump Rotor Spare Part Recalled for Loose Guide Sheaves

    Fresenius Medical Care is recalling approximately 1,156 blood pump rotor spare parts (Model F40015481 Rev A) distributed in the U.S. and Canada due to reports of loose or dislodged guide sheaves after clinical use.

    Product
    190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - 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
  • ModerateFDA (Devices)·Z-2293-2024·2024-07-17

    Total Knee Procedure Kit Recalled for Excess Sterilization Residuals

    American Contract Systems Inc recalls the TOTAL KNEE Procedure Kit due to Ethylene Oxide and Ethylene Chlorohydrin residuals exceeding regulatory limits. No illnesses reported.

    Product
    TOTAL KNEE -Procedure Kit Catalog Number: QPTK95A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2275-2024·2024-07-17

    Knee Procedure Tray Recalled for Excess Sterilization Gas Residue

    American Contract Systems is recalling TOTAL KNEE procedure trays because sterilization gas residuals on the cast padding component exceed regulatory safety limits. No injuries have been reported.

    Product
    TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2296-2024·2024-07-17

    Knee Surgery Procedure Kit Recalled for Ethylene Oxide Residue

    American Contract Systems Inc recalled a knee surgery procedure kit (Catalog RGTK10K) due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits on the cast padding component.

    Product
    TOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2269-2024·2024-07-17

    Breast transilluminator recalled due to lack of FDA premarket approval

    Silkprousa LLC is recalling the Pink Luminous Breast transilluminator because the device was marketed and distributed without FDA premarket approval. All 2,000 units distributed nationwide are subject to recall.

    Product
    Pink Luminous Breast, Breast transilluminator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2339-2024·2024-07-17

    Braun Thermoscan PRO 6000 Recall: Outdated Instructions on Included CD

    Braun Thermoscan PRO 6000 ear thermometers may have been shipped with outdated Instructions for Use on an included CD. Approximately 265,647 units were distributed globally.

    Product
    Braun Thermoscan¿ PRO 6000 Ear Thermometer
    Category
    Medical Device
    Distribution
    0 states
  • 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-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
  • 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
  • HighFDA (Devices)·Z-2226-2024·2024-07-10

    Medline Neuro IR Surgical Kit Recalled Due to Weak Seals

    Medline is recalling Neuro IR surgical convenience kits due to weak seals in the Pure Pouch component that may compromise sterility. The recall affects 12,588 kits distributed nationwide.

    Product
    Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2256-2024·2024-07-10

    BD Pyxis automated dispensing cabinets with noncertified power strips

    BD Pyxis automated dispensing cabinets were shipped with socket-outlet power strips that lack IEC electrical certification, potentially exposing users to leakage currents and electric shock.

    Product
    BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 169-157, BD PYXIS MB TWR MN 1FM-10HH-1FH MP/ 169-143, BD PYXIS MB TWR MN 2FH-1FM-4HH-2FM MP/ 169-145, BD PYXIS MB TWR MN 2FM-8HH-1FH MP/ 169-144, BD PYXIS MB TWR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2268-2024·2024-07-10

    Stryker Diagnostic Electrophysiology Catheters Recalled for Testing Failure

    Stryker Sustainability Solutions is recalling 6 units of BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters because they do not meet FDA testing requirements. The devices were distributed to Japan.

    Product
    Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2264-2024·2024-07-10

    Immunoassay Analyzer Software Defect May Cause Incorrect Test Calibration

    Beckman Coulter is recalling 116 DxI 9000 Immunoassay Analyzers due to a software defect that fails to properly validate calibrator barcodes, potentially resulting in incorrect calibration curves and erroneous patient test results.

    Product
    DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
    Category
    Medical Device
    Distribution
    0 states
  • 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