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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Any3+ (High and above)4+ (High and above)5+ (High and above)

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16051–16075 of 40287

  • LowFDA (Devices)·Z-0405-2021·2020-11-11

    Synthes SYN MESH Vertebral Body Replacement Recalled for Labeling Error

    Synthes (USA) Products LLC is recalling 17 units of SYN MESH vertebral body replacement devices because the statutory label incorrectly identifies them as 'general medical devices' instead of 'specially controlled medical devices.'

    Product
    SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0413-2021·2020-11-11

    Synthes SynMesh Cage System Recalled for Incorrect Statutory Labeling

    Synthes (USA) Products LLC is recalling 6 units of the SynMesh Cage System because the statutory label incorrectly identifies the device as a general medical device.

    Product
    END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0411-2021·2020-11-11

    Synthes SynMesh Cage System Recalled for Incorrect Statutory Labeling

    Synthes (USA) Products LLC is recalling 9 units of the SynMesh Cage System because the statutory label incorrectly identifies the device as a 'general medical device' rather than a 'specially controlled medical device.'

    Product
    END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0415-2021·2020-11-11

    Synthes Vertebral Body Replacement Device Recalled for Labeling Error

    Synthes (USA) Products LLC is recalling 7 units of the Standard Ring 17mm x 22mm (Ti) vertebral body replacement device due to an incorrect statutory label.

    Product
    STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0290-2021·2020-11-04

    GORE TAG CONFORMABLE Thoracic Stent Graft Recall for Deployment Issue

    W L Gore is recalling GORE TAG CONFORMABLE Thoracic Stent Grafts because a secondary deployment fiber attachment prevented completion of deployment via the access hatch.

    Product
    GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0286-2021·2020-11-04

    Boston Scientific Recalls Hurricane RX Biliary Balloon Catheters Due to Detachment Risk

    Boston Scientific is recalling Hurricane RX Biliary Balloon Dilatation Catheters because the black sheath may detach from the shaft. The recall covers 15,062 units in the US and 12,930 internationally.

    Product
    Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930; M00545940; M00545950; M00545960 The device is a double lumen catheter with a balloon mounted at the distal tip. Dilatation balloon catheters are used to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0285-2021·2020-11-04

    Philips Recalls Sterilizable Defibrillator Paddles Due to Undetected Failure Mode

    Philips is recalling 2,202 sterilizable defibrillator paddles because standard periodic checks may fail to detect a specific failure mode in switchless internal models.

    Product
    Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Model Numbers M1741A, M1742A, M1743A, M1744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0309-2021·2020-11-04

    Battelle Recalls Critical Care Decontamination System N95 Respirators

    Battelle Memorial Institute is recalling 898 N95 respirators decontaminated by its Critical Care Decontamination System. The recall is due to a failure to maintain required condensation levels during the decontamination cycle.

    Product
    Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for multiple-user3 reuse by healthcare personnel (HCP)4 to prevent exposure to pathogenic biological airborne particulates when there are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0292-2021·2020-11-04

    Pentax 9372HD Digital Capture Software Recall for Patient Data Error

    Pentax of America Inc. is recalling 39 units of the 9372HD Digital Capture system due to a software issue that may copy exam videos to the wrong patient.

    Product
    9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0293-2021·2020-11-04

    Pentax 9310HD Digital Video Capture Module Recalled for Software Error

    Pentax of America Inc is recalling 39 units of the 9310HD Digital Video Capture Module due to a software issue that may copy patient exam videos to the wrong record.

    Product
    9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0305-2021·2020-11-04

    CMEAmerica BodyGuard Wall Charger Recalled for Charging Defect

    CME America LLC is recalling 27 BodyGuard Wall Chargers because they may not properly charge the infusion pump battery.

    Product
    CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ 16D20191101/* Lot Number Label: BODYGUARD LOT 2019-0364 Manufacturing Date: 2019 - 11-01 , LABEL I.D. SM-0642 REV. 01, CMEAmerica Wall Charger Kit, REF…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0299-2021·2020-11-04

    RTI Surgical Recalls Streamline MIS Navigation System Taps Due to Binding

    RTI Surgical is recalling 420 units of Streamline MIS Navigation System Taps because they have experienced binding with other devices.

    Product
    Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCREWINS-CL-MDN 05-SIMPDRIVER-MDN Product Usage…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0301-2021·2020-11-04

    Smith & Nephew Recalls 5.5MM Arthrogarde Hip Access Cannula

    Smith & Nephew is recalling 143 units of 5.5MM Arthrogarde Hip Access Cannulas because the J Lock feature was manufactured incorrectly, preventing proper locking into irrigation extenders or arthroscopes.

    Product
    5.5MM Arthrogarde Hip Access Cannula
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0291-2021·2020-11-04

    GORE TAG Stent Graft Recalled Due to Delivery Catheter Removal Issue

    W.L. Gore is recalling GORE TAG stent grafts because the delivery catheter could not be withdrawn after implantation.

    Product
    GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0306-2021·2020-11-04

    GE Healthcare Recalls CT Scanners Due to Potential Image Artifacts

    GE Healthcare is recalling 64 CT scanners worldwide because incorrect settings may cause smudge artifacts that could be mistaken for pathology.

    Product
    Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0283-2021·2020-11-04

    Intuitive Surgical Recalls da Vinci Xi Endoscope Controller for Calibration Error

    Intuitive Surgical is recalling one da Vinci Xi Endoscope Controller because improper calibration may cause the endoscope tip to reach higher temperatures, potentially leading to thermal tissue injury.

    Product
    da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an endoscope, surgical instruments, and accessories to perform…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0284-2021·2020-11-04

    Philips Recalls Sterilizable Defibrillator Paddles Due to Undetected Failure Mode

    Philips is recalling 8,942 sterilizable defibrillator paddles because standard checks may miss a specific failure mode. An updated test procedure is available to detect the issue.

    Product
    Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0297-2021·2020-11-04

    Quidel Triage BNP Calibrators Recalled Due to Shipment Compromise

    Medline Industries is recalling 26 Quidel Triage BNP Calibrators because the product was compromised during shipment. The recall affects domestic distribution in CA, NY, TX, and VA.

    Product
    The Quidel Triage BNP Calibrators
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0294-2021·2020-11-04

    Bard 3F SL PowerMidline Kit Recalled for Missing Stylet Assembly

    Becton Dickinson is recalling 45 Bard 3F SL PowerMidline kits in Italy, Spain, and the UK because they lack the stylet/T-lock assembly listed on the label.

    Product
    Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media Ref: P6153118
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0307-2021·2020-11-04

    Exactech Recalls Equinoxe Platform Fracture Stem Due to Incorrect Laser Marking

    Exactech is recalling 25 Equinoxe Platform Fracture Stems because they may be incorrectly laser marked as right stems instead of left stems.

    Product
    Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0303-2021·2020-11-04

    Microbiologics Recalls KWIK-STIK Klebsiella Pneumoniae Due to Incorrect Strain

    Microbiologics Inc is recalling KWIK-STIK Klebsiella pneumoniae units because the product was confirmed to be NDM-1 negative instead of the required NDM-1 positive strain.

    Product
    Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0298-2021·2020-11-04

    Siemens Artis one Fluoroscopic X-Ray Systems Recalled for Monitor Malfunction

    Siemens Medical Solutions is recalling 22 Artis one systems because the examination room monitor may become intermittently dysfunctional, causing display issues.

    Product
    Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0304-2021·2020-11-04

    Microbiologics Recalls KWIK-STIK 2 Pack Due to Incorrect NDM-1 Strain

    Microbiologics Inc is recalling KWIK-STIK 2 Pack units where the NDM-1 positive strain was confirmed to be negative.

    Product
    Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0287-2021·2020-11-04

    Boston Scientific Recalls Visual-ICE MRI Cryoablation System Mobile Connection Panel

    Boston Scientific is recalling one unit of the Visual-ICE MRI Cryoablation System Mobile Connection Panel due to an incorrectly installed base.

    Product
    Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide