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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22026–22050 of 40299

  • ModerateFDA (Devices)·Z-0221-2019·2018-10-31

    Nakanishi SGA-E Surgical Handpieces Recalled for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 18 SGA-E surgical handpieces because reprocessing instructions were updated to include manual cleaning and specific autoclave sterilization parameters.

    Product
    Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0196-2019·2018-10-31

    Medacta MiniMAX Cementless Hip Stem Recalled for Packaging Breach

    Medacta USA Inc. is recalling 837 units of MiniMAX Cementless Anatomical Stems because complaint monitoring identified a trend of packaging breaches.

    Product
    Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0224-2019·2018-10-31

    Nakanishi SGS Surgical Handpieces Recalled for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 1,662 SGS-E2S surgical handpieces because reprocessing instructions were updated to include manual cleaning and specific autoclave parameters.

    Product
    Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible..
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0238-2019·2018-10-31

    Synthes 3.0mm Headless Compression Screws Recalled for Labeling Mismatch

    Synthes (USA) Products LLC is recalling 20 units of 3.0mm Headless Compression Screws because the product inside the package does not match the label.

    Product
    3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0235-2019·2018-10-31

    Stryker Altrix Temperature Management System Recalled for Alarm Faults

    Stryker is recalling 389 Altrix Precision Temperature Management Systems due to frequent alarms and mechanical interference faults.

    Product
    Altrix¿ Precision Temperature Management System Model: 8001Product Usage: The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0229-2019·2018-10-31

    bioMerieux Recalls BACT/ALERT VIRTUO Systems Due to Firmware Calibration Issue

    bioMerieux is recalling 151 BACT/ALERT VIRTUO systems with R2.0 firmware because a software feature may allow calibration standards to be left in incorrect positions, potentially causing anomalies.

    Product
    BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0275-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, communication, and imaging functions.

    Product
    O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number Bl70000027120 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D…
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-0227-2019·2018-10-31

    Terumo Recalls VirtuoSaph Plus Endoscopic Vessel Harvesting System

    Terumo is recalling 135 units of the VirtuoSaph Plus Endoscopic Vessel Harvesting System because one energy platform is not compatible with the device.

    Product
    VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus Endoscopic Vessel Harvesting System VSP550EX is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0228-2019·2018-10-31

    bioMerieux Recalls BACT/ALERT VIRTUO Systems Due to Firmware Calibration Issue

    bioMerieux is recalling 516 BACT/ALERT VIRTUO systems with R2.0 firmware because a service feature may leave calibration standards in incorrect locations, potentially causing anomalies.

    Product
    BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0219-2019·2018-10-31

    Nakanishi Surgical Handpiece Recall for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 12 SGS-E surgical handpieces to replace operation manuals with updated reprocessing instructions for manual cleaning and autoclave sterilization.

    Product
    Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0231-2019·2018-10-31

    Ecolab recalls sterile instrument arm drapes due to potential seal defects

    Ecolab is recalling specific lots of sterile instrument arm drapes for the Da Vinci Si system because seal wrinkles may compromise sterility.

    Product
    Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system Distribute by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0270-2019·2018-10-31

    Ameditech Recalls Accutest Drug Test Cups Missing Adulteration Strip

    Ameditech Inc is recalling Accutest Drug Test Cup 5+3 units because they were released without the required adulteration strip.

    Product
    Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detection of multiple drugs in human urine. The test is intended as the first step in a two-step process to provide consumers with information concerning the…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0103-2019·2018-10-24

    Thoratec CentriMag Motor Recall Due to Electrical Cable Failure

    Thoratec is recalling CentriMag Motors because a wire break or short circuit in the cable can cause the motor to stop.

    Product
    Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.
    Category
    Medical Device
    Distribution
    43 states
  • SevereFDA (Devices)·Z-0181-2019·2018-10-24

    OriGen Biomedical Recalls Reinforced Dual Lumen Cannulas Due to Deficiencies

    OriGen Biomedical is recalling 435 Reinforced Dual Lumen Cannulas because they may lack barium sulfate and have tips shorter than labeled.

    Product
    Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0178-2019·2018-10-24

    Siemens Biograph mCT PET/CT Scanners Recalled for Plug Overheating Risk

    Siemens Medical Solutions is recalling 890 Biograph mCT PET/CT scanners because plug terminals may become loose and overheat.

    Product
    Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material Number 10507786 c) Flow 20-4R, Material Number 10528958 d) m Flow 64-4R, Material Number 10529161 e) mCT S(40)-4R, Material Number 10248671 f) mCT S(64)-4R, Material Number 0248672 g) mCT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0147-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 14 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.

    Product
    Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number 814409320 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0177-2019·2018-10-24

    Siemens Biograph Horizon PET/CT Scanners Recalled for Plug Overheating Risk

    Siemens Medical Solutions is recalling 78 Biograph Horizon PET/CT scanners because loose plug terminals may overheat.

    Product
    Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon and Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0173-2019·2018-10-24

    Life Technologies Recalls Gibco Sodium Pyruvate Due to Leaky Bottle Caps

    Life Technologies is recalling 41 units of Gibco Sodium Pyruvate (100 mM) because defective bottle caps may compromise product sterility.

    Product
    Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0148-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 29 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The devices were distributed in the US and abroad.

    Product
    Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0139-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 24 units of Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers US and foreign distribution.

    Product
    Affixus Hip Fracture Nail Right 125 13 mm x 260 mm, Item Number 814313260 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0170-2019·2018-10-24

    Mindray BeneVision Distributed Monitoring System Recalled for ECG Display Anomalies

    Mindray is recalling five BeneVision Distributed Monitoring Systems due to a software issue that can cause ECG waveforms to display as a flat line when more than 64 telemetry transmitters are connected.

    Product
    Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0131-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 153 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.

    Product
    Affixus Hip Fracture Nail 125 11mm x 180mm, Item Number 814311180 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0183-2019·2018-10-24

    OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Manufacturing Deficiencies

    OriGen Biomedical is recalling 241 units of ECMO Reinforced Dual Lumen Cannulas due to missing barium sulfate and inaccurate tip length labeling.

    Product
    ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0111-2019·2018-10-24

    GE Healthcare MRI Systems Software Recall - On-Site Software Not Reinstalled

    GE Medical Systems is recalling MRI systems because the latest software version was not properly reinstalled after service, potentially causing image flipping and patient data mismatch.

    Product
    GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH 400-AP, MR GOLDSEAL 1.5T HD 8CH USED, UPGRADE 1.5 EXC-II TO EXC-III HD, SIGNA MR/I HISPD W/ EXCITE, 1.5 ECHOSPEED HD 16-CH 800-AP, 1.5…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0164-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 19 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.

    Product
    Affixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number 814609360 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide