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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5851–5875 of 13543

  • HighFDA (Devices)·Z-2334-2024·2024-07-17

    Medical Injection Kit Recall Due to Unconfirmed Sterilization

    MICROspecialties is recalling Synergetics I-Pack Injection Kits because some units may not have been properly sterilized, potentially causing post-operative wound or injection site infections.

    Product
    Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061
    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-2287-2024·2024-07-17

    Knee Scope Procedure Tray Recalled for Excess Sterilization Residue Levels

    American Contract Systems Inc. is recalling KNEE SCOPE Procedure Tray kits because ethylene oxide sterilization residues in the cast padding component exceed safe exposure limits per FDA and ISO standards.

    Product
    KNEE SCOPE Procedure tray Catalog Number: COKN48L
    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-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
    0 states
  • 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-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-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-2286-2024·2024-07-17

    Procedure Tray Recalled Due to Excess Sterilization Residue

    American Contract Systems Inc is recalling HAND WRIST FOREARM-LF Procedure trays due to ethylene oxide sterilization residues exceeding safe limits for permanent exposure devices.

    Product
    HAND WRIST FOREARM-LF Procedure tray Catalog Number: CCHD17B
    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-2328-2024·2024-07-17

    Cardinal Health Cardiac Catheterization Kits Recalled for Potential Syringe Design Defect

    Cardinal Health is recalling Presource Cardiac Catheterization Kits because the included syringes may have design defects that could cause inaccurate dosing or leakage, creating a risk of patient harm.

    Product
    Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB; 2) Cardiac Catheterization Kit, Catalog Number SAN73CCV10; 3) Cardiac Catheterization Kit, Catalog Number SAN73CCV11; 4) Cardiac Catheterization Kit, Catalog Number SAN73CCV1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2327-2024·2024-07-17

    Presource surgical kits recalled for syringe design defect risk

    Cardinal Health is recalling 136,753 Presource surgical kits nationwide because included Shenli syringes contain design modifications that could cause inaccurate dosing and device leakage, risking patient harm.

    Product
    Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog Number SAN13BS606; 3) ANGIOGRAPHY PACK, Catalog Number SAN13BS607; 4) ANGIOGRAPHY PACK, Catalog Number SAN13BS608; 5) ANGIOGRAPHY PACK, Catalog Number SAN13BS6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2320-2024·2024-07-17

    Medical examination gloves recalled for skin irritation and disintegration

    SVS LLC is recalling 155,540 boxes of non-sterile nitrile examination gloves due to reported skin irritation, glove disintegration with certain cleaning solutions, and size mislabeling. Gloves were distributed nationwide across eight U.S. states.

    Product
    Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The range of sizes inc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2309-2024·2024-07-17

    Orthopedic ORIF Hip Rod Procedure Kit Recalled for Sterilization Residuals

    American Contract Systems Inc is recalling its ORIF HIP IM RODDING FEMUR-Procedure Kit (28 units) because ethylene oxide and ethylene chlorohydrin residuals in the cast padding exceeded safe limits for permanent implants.

    Product
    ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-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-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-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
  • 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
  • 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