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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20176–20200 of 27647

  • HighFDA (Devices)·Z-1234-2017·2017-03-01

    Custom Medical Specialties Recalls Biopsy Trays with Syringes Due to Sterility Concerns

    Custom Medical Specialties is recalling 80 biopsy trays containing syringes because the sterility of the syringes could not be assured. The affected products were distributed to Idaho and Oregon.

    Product
    CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1163-2017·2017-03-01

    Biomet Recalls Oxford Knee Instruments Due to Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Left Medial Tibial Trial Tray Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Devices)·Z-1188-2017·2017-02-22

    GE Healthcare Recalls Discovery MR450 MRI Scanners Due to Burn Risk

    GE Healthcare is recalling 60 Discovery MR450 MRI scanners because a component failure can cause the patient bore to heat up, potentially leading to serious burns.

    Product
    Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1192-2017·2017-02-22

    Integra Cadence Total Ankle System Recalled Due to Tibial Fractures

    Integra LifeSciences Corp. is recalling 944 units of the Cadence Total Ankle System because posterior tibial fractures have been reported.

    Product
    Integra Cadence Total Ankle System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1123-2017·2017-02-22

    Physio-Control Recalls LIFEPAK 15 Defibrillators Due to Relay Failure

    Physio-Control is recalling 338 LIFEPAK 15 defibrillators because an internal relay may fail, preventing the device from delivering defibrillation energy.

    Product
    LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1215-2017·2017-02-22

    Siemens PRIMUS Radiation Therapy Systems Recalled for Collimator and Weld Defects

    Siemens is recalling 194 PRIMUS radiation therapy systems due to incorrect collimator position displays and improper weld seams at the overhead suspension.

    Product
    PRIMUS Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1193-2017·2017-02-22

    Stryker Restoris RIO Reamer Handle Recalled for Engagement Failure

    Mako Surgical Corporation is recalling 595 Stryker Restoris RIO Reamer Handles because they may fail to engage mating components during surgery.

    Product
    Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1103-2017·2017-02-22

    Zimmer Biomet Recalls Reverse Shoulder Humeral Trays Due to Fracture Risk

    Zimmer Biomet is recalling 4,388 Comprehensive Reverse Shoulder System Humeral Trays because they are fracturing at higher-than-anticipated rates, posing a risk of revision surgery.

    Product
    Comprehensive Reverse Shoulder System Humeral Tray Model 115340
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1194-2017·2017-02-22

    Argon Medical Devices Recalls Bone Marrow Aspiration Needles Due to Sterility Risk

    Argon Medical Devices is recalling specific bone marrow aspiration needles because a potential defect in the blister packaging may compromise the sterility of the product.

    Product
    BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of harvesting bone and/or bone marrow specimens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1201-2017·2017-02-22

    Terumo Recalls Hercules 360 Universal Stabilizing Arms Due to Pin Separation

    Terumo CVS is recalling Hercules 360 Universal Stabilizing Arms because pins may come loose and fall into the surgical site.

    Product
    Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1218-2017·2017-02-22

    Aesculap GN200 Caiman HF Generators Recalled for Faulty Component

    Aesculap Implant Systems LLC is recalling 24 GN200 Caiman HF generators due to a faulty component that may impact proper device functioning.

    Product
    GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1219-2017·2017-02-22

    Zimmer Biomet Recalls Vanguard Total Knee Plates Due to Material Inclusions

    Zimmer Biomet is recalling Vanguard Total Knee punch-through trial plates due to potential alumina inclusions in the raw material that could cause the instruments to crack or separate.

    Product
    Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM Item No: 32-487265
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1206-2017·2017-02-22

    Atrium Medical Recalls Maquet Ocean Water Seal Chest Drains

    Atrium Medical Corporation is recalling Maquet Ocean Water Seal Chest Drains because the manual vent valve may fail to re-seal after use.

    Product
    Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1210-2017·2017-02-22

    Atrium Medical Recalls Maquet Express Dry Seal Suction OCEAN DRAIN Chest Drains

    Atrium Medical Corporation is recalling Maquet Express Dry Seal Suction OCEAN DRAIN chest drains because the manual vent valve may fail to re-seal after use.

    Product
    Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1214-2017·2017-02-22

    Siemens Recalls ONCOR Radiation Therapy Systems Due to Collimator and Weld Defects

    Siemens is recalling 194 ONCOR radiation therapy systems in the US due to incorrect collimator position displays and improper weld seams.

    Product
    ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1191-2017·2017-02-22

    Encore Medical Recalls LIMA Modular Revision Hip Stems Due to Sterilization Error

    Encore Medical is recalling 13 LIMA Modular Revision Hip Stems because they were inadvertently re-sterilized, which may compromise the integrity of the safety screw.

    Product
    LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of a modular stem coupled with a proper neck by means of a Morse taper stabilized during the implantation phase by a safety screw. This system is particularly…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1195-2017·2017-02-22

    Argon Medical Devices Recalls T-LOK Bone Marrow Biopsy Needles

    Argon Medical Devices is recalling T-LOK bone marrow biopsy needles due to a potential defect in the blister packaging that may compromise sterility.

    Product
    T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN Intended for the purpose of harvesting bone and/or bone marrow specimens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1202-2017·2017-02-22

    Abbott StarClose SE Vascular Closure System Recall for Deployment Failure

    Abbott Vascular is recalling the StarClose SE Vascular Closure System because the device may fail to deploy the clip.

    Product
    StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1197-2017·2017-02-22

    Advanced Sterilization Products Recalls STERRAD NX Sterilization Systems

    Advanced Sterilization Products is recalling STERRAD NX Sterilization Systems because the door interlock may disengage for 20 seconds after a power outage.

    Product
    STERRAD NX Sterilization System, Product Code: 10033, 10033-002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1209-2017·2017-02-22

    Atrium Medical Recalls Maquet Express Dry Seal Suction Chest Drains

    Atrium Medical Corporation is recalling Maquet Express Dry Seal Suction chest drains because the manual vent valve may fail to re-seal after being depressed.

    Product
    Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1203-2017·2017-02-22

    Merge Healthcare Recalls Schiller PB 1000 Blood Pressure Pumps

    Merge Healthcare is recalling Schiller PB 1000 blood pressure pumps because insufficient voltage causes them to fail before reaching adequate pressure.

    Product
    The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1205-2017·2017-02-22

    Atrium Medical Recalls Maquet Ocean Water Seal Chest Drains

    Atrium Medical is recalling Maquet Ocean Water Seal Chest Drains because the manual vent valve may fail to re-seal after being depressed.

    Product
    Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1207-2017·2017-02-22

    Atrium Medical Recalls Maquet Oasis Chest Drains Due to Valve Defect

    Atrium Medical is recalling Maquet Oasis chest drains because the manual vent valve may fail to re-seal after use.

    Product
    Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1211-2017·2017-02-22

    Atrium Medical Recalls Maquet Express Dry Seal Suction OASIS Drain

    Atrium Medical Corporation is recalling 18 units of Maquet Express Dry Seal Suction OASIS Drain because the manual vent valve may fail to re-seal.

    Product
    Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and…
    Category
    Medical Device
    Distribution
    Distributed nationwide