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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12601–12625 of 27470

  • HighFDA (Devices)·Z-0463-2021·2020-11-25

    Medicrea Ligapass Tension Pulley Handle Recalled for Band Breakage Risk

    Medicrea International is recalling Ligapass Tension Pulley Handles because the instrument can crush the band, causing it to break during surgery and leading to infection risk.

    Product
    MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0473-2021·2020-11-25

    Siemens Atellica IM 1300 Analyzer Recalled for Test Definition Scanning Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers because scanning specific test definitions may reset custom settings, causing inaccurate test results.

    Product
    Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0425-2021·2020-11-18

    Puritan Bennett 980 Ventilator Recalled for Battery Overheating Risk

    Covidien is recalling Puritan Bennett 980 ventilators due to battery overheating and thermal damage risks that could cause burns or smoke exposure.

    Product
    Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation SKU: 980X1ENDIUU 980X1ENDIUU 980X3FRAIQC 980X3DEDRAC 980X3ENNISB 980X3NLDRAC…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0430-2021·2020-11-18

    Stereotaxis Niobe ES System Recalled for Potential Fire Hazard

    Stereotaxis Inc is recalling 121 Niobe ES Systems due to a potential fire risk in the internal computer cabinet.

    Product
    Niobe ES System, Models 001-006000-1 and 001-006100-1
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0431-2021·2020-11-18

    Stryker Recalls Cranial Perforators Due to Potential Metal Fragment Risk

    Stryker is recalling Zyphr Disposable Cranial Perforators because a crack in the inner bit could release metal fragments into the surgical site or cause delayed disengagement.

    Product
    Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. Catalog Number: 5100-060-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0439-2021·2020-11-18

    Fresenius Liberty Select Cycler Software Recall for Inadequate Dialysis Risk

    Fresenius Medical Care is recalling Liberty Select Cycler devices with software version 2.9.0 because a software error may cause the device to fail to recognize extra fluid, potentially leading to inadequate dialysis.

    Product
    Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0446-2021·2020-11-18

    United Imaging uCT 550 CT Scanners Recalled for Timer Display Error

    Shanghai United Imaging Healthcare is recalling five uCT 550 CT scanners because an incorrect delay timer display may expose operators to unnecessary radiation.

    Product
    Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0445-2021·2020-11-18

    United Imaging uCT 530 CT Scanner Recalled for Incorrect Timer Display

    Shanghai United Imaging Healthcare Co., Ltd. is recalling four uCT 530 CT scanners because an incorrect delay timer may display, potentially exposing operators to unnecessary radiation.

    Product
    Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0427-2021·2020-11-18

    Boston Scientific AMS 700 MS Pump Recall for Activation Difficulties

    Boston Scientific is recalling AMS 700 MS Pumps due to reports of difficulty activating the device to inflate cylinders.

    Product
    AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0447-2021·2020-11-18

    United Imaging uCT 760 CT Scanner Recalled for Timer Display Error

    Shanghai United Imaging Healthcare is recalling five uCT 760 CT scanners because a display error may cause operators to receive unnecessary radiation exposure.

    Product
    Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0428-2021·2020-11-18

    Quidel SARS Antigen Test Kits Recalled for False Positive Results

    Quidel is recalling 8,628 SARS Antigen FIA test kits due to false positive results. The affected units were distributed to 24 U.S. states.

    Product
    QUIDEL Sofia SARS Antigen FIA IVD REF 20374
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0448-2021·2020-11-18

    United Imaging uMI 550 PET/CT System Recalled for Incorrect CT Scan Delay Timer

    Shanghai United Imaging Healthcare is recalling nine uMI 550 PET/CT systems because an incorrect CT scan delay timer may display, potentially exposing operators to unnecessary radiation.

    Product
    Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0432-2021·2020-11-18

    Inpeco FlexLab Automation System Recalled for Potential Sample Dilution

    Inpeco S.A. is recalling 93 FlexLab Automation Systems with Aliquoter Modules because a software error may cause samples to be diluted with water, leading to erroneous test results.

    Product
    FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0443-2021·2020-11-18

    Maquet BMU 40 Blood Monitoring Units Recalled for Electrical Safety Non-Compliance

    Maquet Cardiovascular is recalling 51 Blood Monitoring Units (BMU 40) because the printed circuit boards do not meet IEC electrical safety standards for creepage distance.

    Product
    Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0434-2021·2020-11-18

    Inpeco Aptio Automation System Recall for Potential Sample Dilution

    Inpeco S.A. is recalling 104 Aptio Automation Systems with Aliquoter Modules because a software error may cause samples to be diluted with water, leading to erroneous test results.

    Product
    Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0433-2021·2020-11-18

    Inpeco Accelerator a3600 Aliquoter Module Recall for Sample Dilution Risk

    Inpeco S.A. is recalling 136 Accelerator a3600 Automation Systems with Aliquoter Modules due to a software error that may dilute samples with water, leading to erroneous test results.

    Product
    Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0344-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Prosthesis Cups Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 acetabular hip prosthesis cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 55 mm Item Number: 00-8065-552-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0338-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 acetabular hip cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0373-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cup Components Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 acetabular hip cup components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Number: 00-8065-650-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0399-2021·2020-11-11

    Cook Inc. Recalls Fixed Core Wire Guides Due to Manufacturing Defects

    Cook Inc. is recalling 61 Fixed Core Wire Guides that may be bent or contain loose foreign matter due to being dropped during manufacturing.

    Product
    Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devices in vascular applications.
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0335-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Cup Hip Prosthesis Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 51 mm Item Number: 00-8065-548-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0346-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 57 mm Number: 00-8065-554-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0333-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cup Components Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 acetabular hip cup components because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22mm, Neutral, O.D. Cup with Spacers, 51 mm Item Number: 00-8065-548-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0345-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 57 mm Item Number: 00-8065-554-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0326-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 acetabular hip cup components because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 47 mm Item Number: 00-8065-544-22
    Category
    Medical Device
    Distribution
    Distributed nationwide