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 the agency’s own highest classification or reported deaths or serious injuries, 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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34201–34225 of 40449

  • LowFDA (Devices)·Z-0557-2015·2014-12-17

    Instrumed Recalls Cloward Spanner Gauges Due to Regulatory Non-Compliance

    Instrumed International is withdrawing Cloward Spanner gauges because the company did not market them before 1976, failing to meet FDA requirements for pre-amendment devices.

    Product
    Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0549-2015·2014-12-17

    Instrumed Recalls Galt Trephines for Regulatory Compliance Issues

    Instrumed International is withdrawing Galt trephines because the company did not market them prior to September 26, 1976, failing to meet FDA pre-amendment requirements.

    Product
    Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion brand name.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0550-2015·2014-12-17

    Instrumed Recalls Gardner-Wells Traction Tongs for Regulatory Compliance

    Instrumed International is withdrawing 190 Gardner-Wells traction tongs because the company did not market them before September 26, 1976, failing to meet FDA pre-amendment requirements.

    Product
    Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0534-2015·2014-12-17

    Instrumed Recalls Zipser Meatus Clamps Due to Regulatory Non-Compliance

    Instrumed International is withdrawing 81 Zipser Meatus Clamps because the company did not market the devices prior to 1976, failing to meet FDA requirements for pre-amendment devices.

    Product
    A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0548-2015·2014-12-17

    Instrumed Recalls Hudson Cranial Drill Sets for Regulatory Non-Compliance

    Instrumed International is withdrawing five Hudson cranial drill sets because the company failed to meet FDA requirements for marketing pre-amendment devices.

    Product
    Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, Stealth Surgical, and Boss Instruments brand names.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0458-2015·2014-12-10

    ConMed Adult Radiotransparent Electrode Recall Due to Connection Failure Risk

    ConMed is recalling Adult Radiotransparent Electrodes because design changes to Philips AEDs may prevent connection, delaying therapy and risking patient death or serious injury.

    Product
    ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0462-2015·2014-12-10

    ConMed Multifunction Electrodes Recalled for Connection Design Failure

    ConMed is recalling multifunction electrodes due to a design change that may prevent connection to Philips AEDs, potentially delaying therapy.

    Product
    CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0460-2015·2014-12-10

    ConMed Pediatric Electrodes Recalled Due to Connection Design Changes

    ConMed is recalling 174,610 pediatric electrodes because design changes to Philips AEDs may prevent connection, delaying therapy and risking death or serious injury.

    Product
    MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR--Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0296-2015·2014-12-10

    Customed Laparotomy Packs Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 892 Laparotomy Packs (Catalog 900-149) because compromised sterility and inadequate storage conditions may result in patient infection.

    Product
    Laparotomy Pack, Catalog number 900-149. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-0456-2015·2014-12-10

    ConMed Adult Radiotransparent Electrodes Recalled for Connection Design Changes

    ConMed is recalling 174,610 Adult Radiotransparent Electrodes because design changes to Philips AED connections may cause therapy delays, risking patient death or serious injury.

    Product
    ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0457-2015·2014-12-10

    ConMed Adult Radiotransparent Electrode Recall Due to Connection Design Changes

    ConMed is recalling 174,610 Adult Radiotransparent Electrodes because design changes to Philips AED connections may cause therapy delays, risking patient death or serious injury.

    Product
    ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0311-2015·2014-12-10

    Customed Minor Laparotomy Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 625 Minor Laparotomy Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Minor Laparotomy Pack, Catalog number 900-1735. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-0455-2015·2014-12-10

    ConMed Adult Radiotransparent Electrode Recall Due to Connection Design Changes

    ConMed is recalling Adult Radiotransparent Electrodes because design changes to Philips AED connections may cause connection failures, potentially delaying therapy and resulting in patient death or serious injury.

    Product
    ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0461-2015·2014-12-10

    ConMed Pediatric Multifunction Electrodes Recalled for Connection Design Flaws

    ConMed is recalling Pediatric R2 Multifunction Electrodes because design changes to the connection with Philips Heartstart devices may cause connection failures, potentially delaying therapy and leading to patient death or serious injury.

    Product
    CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0459-2015·2014-12-10

    ConMed Pediatric Radiotransparent Electrode Recall Due to Connection Design Changes

    ConMed is recalling 174,610 pediatric radiotransparent electrodes because design changes to Philips AED connections may cause therapy delays, risking patient death or serious injury.

    Product
    PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0383-2015·2014-12-10

    Customed Minor Laparotomy Packs Recalled for Sterility Compromise

    Customed, Inc. is recalling 250 Minor Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Minor Laparotomy Pack, Catalog number 900-450. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-0454-2015·2014-12-10

    ConMed Adult Radiotransparent Electrodes Recalled for Connection Design Failure

    ConMed is recalling Adult Radiotransparent Electrodes because a design change in Philips AEDs may prevent connection, delaying therapy and risking patient death or serious injury.

    Product
    ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0358-2015·2014-12-10

    Customed Tummy Tuck and Liposuction Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling six Tummy Tuck & Liposuction Packs due to compromised sterility and manufacturing deficiencies that pose a risk of patient infection.

    Product
    Tummy Tuck & Liposuction Pack, catalog #900-2661 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0408-2015·2014-12-10

    Customed Plastic Surgery Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 105 Plastic Surgery Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Plastic Surgery Pack, Catalog # 900-920 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0348-2015·2014-12-10

    Customed Minor Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 944 Minor Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Minor Pack, catalog #900-2511 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0255-2015·2014-12-10

    Customed Medical Leggings Recalled Due to Compromised Sterility

    Customed, Inc. is recalling medical leggings used for patient care procedures because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.

    Product
    Leggings W/7'' Cuff, Catalog number 900-1574. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0382-2015·2014-12-10

    Customed Cysto Tur Pack Recalled Due to Sterility Compromise

    Customed, Inc. is recalling 75 units of Cysto Tur Pack (Catalog 900-430) due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Cysto Tur Pack, Catalog number 900-430 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0372-2015·2014-12-10

    Customed Face Lift Recall Due to Sterility and Contamination Risks

    Customed, Inc. is recalling 20 units of Face Lift products (Catalog 900-3083) due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Face Lift, Catalog number 900-3083. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0407-2015·2014-12-10

    Customed Medical Kits Recalled for Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 100 units of medical kits (Catalog # 900-913) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    , Catalog # 900-913 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0375-2015·2014-12-10

    Customed Breat Pack-TPSC Recalled for Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 63 Breat Pack-TPSC units due to compromised sterility and manufacturing deficiencies that may lead to patient infection.

    Product
    Breat Pack-TPSC, Catalog number 900-3431. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states