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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15901–15925 of 40287

  • 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
  • ModerateFDA (Devices)·Z-0451-2021·2020-11-25

    Ortho Recalls VITROS Anti-SARS-CoV-2 IgG Control Due to Signal Issues

    Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 IgG Control and Calibrator lots due to elevated signal/cutoff values and decreased signal.

    Product
    VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodiagnostic and Integrated Systems when used for the determination of IgG antibodies to SARS-CoV-2. Product Code (Unique Identifier)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0462-2021·2020-11-25

    LivaNova VNS Therapy AspireSR Generator Recall for Serial Number Error

    LivaNova is recalling 134 VNS Therapy AspireSR Generators because an extra digit in the serial number makes them incompatible with specific therapy programmers.

    Product
    VNS Therapy¿ AspireSR¿ Generator
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0469-2021·2020-11-25

    Siemens Artis X-Ray Systems Recalled for Overvoltage Protection Defect

    Siemens is recalling 26 Artis X-ray systems worldwide because incorrect diodes may fail to protect against overvoltage, potentially causing system malfunction.

    Product
    Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0468-2021·2020-11-25

    Strauss 25 Carbide Dental Burs Recalled for Incorrect Packaging

    Coltene Whaledent Inc is recalling Strauss 25 Carbide Dental Burs because they were incorrectly packaged as a different model, posing a risk of excessive material removal.

    Product
    Strauss 25 Carbide Dental Burs (100057XXV)
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0459-2021·2020-11-25

    Exactech Equinoxe Cage Glenoid Posterior Augment Recalled for Mislabeling

    Exactech, Inc. is recalling 69 Equinoxe Cage Glenoid, Posterior Augment, Left, Medium devices because they may be mislabeled.

    Product
    Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-0474-2021·2020-11-25

    Siemens Atellica IM 1600 Analyzer Recalled for Custom Settings Reset

    Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzers because scanning a new kit lot may reset custom settings to defaults.

    Product
    Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0450-2021·2020-11-25

    Ortho Recalls VITROS SARS-CoV-2 IgG Calibrators Due to Elevated Signal Values

    Ortho Clinical Diagnostics is recalling specific lots of VITROS SARS-CoV-2 IgG Calibrators because they produced elevated signal values. The recall also includes one lot of IgG Controls with decreased signal.

    Product
    VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0440-2021·2020-11-25

    Inova Lasers Recalls Class IV New Era Medical Laser Devices

    Inova Lasers LLC is recalling eight Class IV New Era medical laser devices because they failed to comply with Electronic Product Radiation Control regulations.

    Product
    Class IV New Era medical laser device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0460-2021·2020-11-25

    Exactech Equinoxe Cage Glenoid Posterior Augment Recalled for Mislabeling

    Exactech is recalling 40 Equinoxe Cage Glenoid, Posterior Augment, Right, Medium devices due to potential mislabeling. The devices were distributed to US and international consignees.

    Product
    Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
    Category
    Medical Device
    Distribution
    21 states
  • LowFDA (Devices)·Z-0458-2021·2020-11-25

    Steris Olympus Leak Test Adapter Recalled for Cleaning Solution Intrusion Risk

    Steris Corporation is recalling Olympus Leak Test Adapters used with Acu-sInQ systems due to a potential for cleaning solution to intrude into endoscopes.

    Product
    Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0471-2021·2020-11-25

    Ortho VITROS Chemistry Performance Verifier II Recalled for Product Instability

    Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Performance Verifier II due to product instability that causes biased ALKP values.

    Product
    VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0401-2021·2020-11-25

    Merz Recalls COAPTITE Injectable Implant Due to Documentation Mismatch

    Merz North America is recalling 2,051 units of COAPTITE Injectable Implant because the Instructions for Use do not match post-approval study data.

    Product
    COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel carrier. Gel carrier is composed of sodium carboxymethylcellulose, sterile water…
    Category
    Medical Device
    Distribution
    48 states
  • LowFDA (Devices)·Z-0470-2021·2020-11-25

    Micro-Tech Elastic Traction Device Recalled for Regulatory Classification Issues

    Micro-Tech USA is recalling Elastic Traction Devices because they are not appropriately classified as Class I and require 510(k) clearance.

    Product
    Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the gastrointestinal tract.
    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