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 deaths or serious injuries are reported, 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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12451–12475 of 13802

  • ModerateFDA (Devices)·Z-0438-2022·2022-01-05

    VIDAS SARS-CoV-2 IgM Diagnostic Test Recalled for Substrate Error

    bioMerieux is recalling one lot of VIDAS SARS-CoV-2 IgM tests nationwide due to a substrate defect that prevents the test from running. The defect causes delayed results as users must repeat testing.

    Product
    VIDAS SARS-COV-2 IgM, Ref 423833-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0383-2022·2021-12-29

    Stealthstation and Synergy Cranial surgical navigation system software synchronization error

    Stealthstation and Synergy Cranial surgical navigation systems may display an incorrect biopsy needle position due to software synchronization failure. This could result in prolonged surgery, additional procedures, or tissue injury.

    Product
    Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585
    Category
    Medical Device
    Distribution
    51 states
  • SevereFDA (Devices)·Z-0394-2022·2021-12-29

    WIRION Embolic Protection System Filter Withdrawal Difficulties

    Cardiovascular Systems Inc recalls WIRION Embolic Protection System devices (6Fr) because the filter assembly may become difficult to withdraw, and the device may tear or separate, creating a risk of blood clot embolization.

    Product
    WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0415-2022·2021-12-29

    Surgical Suction Instruments Recalled for Calibration Defect Risk

    Acclarent's TruDi NAV Suction Instruments may be incorrectly calibrated, affecting surgical navigation accuracy. If undetected, the error could cause tissue damage, arterial injury, or nerve damage.

    Product
    TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-0395-2022·2021-12-29

    VirtuTRAX Instrument Navigator Sensor May Fail to Tighten

    Civco Medical recalls VirtuTRAX Instrument Navigator sensors that may fail to tighten onto instruments during use. No injuries reported.

    Product
    VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0402-2022·2021-12-29

    Nurse Call Communication System Components May Fail to Reboot

    Hill-Rom's NaviCare and Voalte nurse call communication systems may experience an unrecoverable software error causing components to fail reboot cycles and become non-functional, requiring replacement.

    Product
    These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0 *Product was rebranded from NaviCare to Voalte in 2020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0417-2022·2021-12-29

    Surgical Navigation Tracker Subject to Weld Failure and Navigation Inaccuracy

    A surgical navigation tracker used in neurosurgery may experience weld failure, leading to navigation inaccuracy, prolonged procedure time, and potential tissue injury. 98 affected units were distributed across US and international healthcare facilities.

    Product
    Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit.
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-0403-2022·2021-12-29

    Hemashield Gold Knitted Bifurcated Vascular Graft Mislabeling Recall

    Maquet Cardiovascular is recalling Hemashield Gold vascular grafts due to probable mislabeling. A different graft product may have been packaged in the carton.

    Product
    Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0406-2022·2021-12-29

    Surgical Corneal Kit Packaging May Compromise Product Sterility

    Beaver Visitec is recalling the Malosa Core Surface Treatment Pack surgical kit because packaging may have holes that compromise sterility during eye procedures.

    Product
    Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK110/3
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0411-2022·2021-12-29

    Newborn Kit Needles Recalled Due to Sterility Defect

    ROi CPS LLC is recalling regard Clinical Packaging Solutions Newborn Kits (Item 830096005) containing non-sterile needles. The kits were distributed to Missouri.

    Product
    regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0397-2022·2021-12-29

    VirtuTRAX Instrument Navigator Sensor May Fail to Tighten Properly

    Civco Medical Instruments is recalling VirtuTRAX Instrument Navigator sensors because they may fail to tighten properly onto surgical instruments. This functional defect could affect safe use during medical procedures.

    Product
    VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0412-2022·2021-12-29

    Leica M220 F12 Surgical Microscope Optics Carrier May Drop Into Surgical Field

    Leica Microsystems is recalling 2,800 M220 F12 surgical microscopes because the optics carrier may unintentionally drop into the surgical field, risking patient contact. No injuries have been reported.

    Product
    Leica Microsystems M220 F12 Microscope Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0416-2022·2021-12-29

    Philips Allura Xper FD Ceiling Monitors Risk Falling Due to Loose Screws

    Set screws on ceiling-mounted extra monitors can loosen, causing monitors to fall and potentially injure patients, staff, or service technicians.

    Product
    Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012, 722013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0401-2022·2021-12-29

    Wright Medical CHARLOTTE MTP Hex Screw Recall: Incorrect Product in Packaging

    Wright Medical recalled 22 units of CHARLOTTE MTP Hex Screws with incorrect product in packaging. Affected lots 02010697711582590 and 02010697711582591 were distributed to surgical facilities in the US, Canada, Australia, Spain, UK, and Chile.

    Product
    Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0399-2022·2021-12-29

    Cholesterol Reagent Recalled for Calibration Failures and Erroneous Results

    Beckman Coulter is recalling 1,433 units of a cholesterol reagent that may fail calibration and produce erroneous low test results. Affected units were distributed nationwide and internationally.

    Product
    SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0405-2022·2021-12-29

    Malosa Core LASIK Pack Recalled for Sterility-Compromising Packaging Defects

    Beaver Visitec International recalls 920 units of Malosa Core LASIK Pack due to packaging holes that may compromise product sterility. Compromised sterility creates infection risk in surgical use.

    Product
    Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK100/2
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0393-2022·2021-12-29

    Stryker DARCO Screw Recall: Incorrect Product in Packaging

    Wright Medical Technology Inc is recalling 250 units of Stryker DARCO Screws (Lot #1643355) because the incorrect product was found in the packaging. Affected units were distributed across multiple U.S. states and countries worldwide.

    Product
    Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0409-2022·2021-12-29

    Malosa Core SMILE Pack Medical Refractive Kit Recalled for Packaging Defect

    Beaver Visitec International is recalling the Malosa Core SMILE Pack 1-Medical Refractive Kit because packaging may contain small holes that compromise sterility. The recall affects 680 units distributed in nine states.

    Product
    Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0410-2022·2021-12-29

    Medical Refractive Surgery Kit Recalled for Sterility-Compromising Packaging Defects

    Beaver Visitec is recalling 1,170 units of its Malosa Core SMILE Pack 2 surgical refractive kit because packaging may contain small holes that could compromise sterility. Affected units were distributed across nine states.

    Product
    Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK967
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0398-2022·2021-12-29

    VirtuTRAX Instrument Navigator devices may not tighten properly

    Civco Medical Instruments is recalling VirtuTRAX Instrument Navigator devices due to a potential mechanical failure that could prevent proper securing of instruments. The device may not tighten onto the instrument as intended.

    Product
    VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0414-2022·2021-12-29

    Skinny Needle with Chiba Tip recalled for debris contamination

    Cook Inc. is recalling Skinny Needles with Chiba Tip due to black debris on internal components that may cause local inflammatory reactions if the product is used.

    Product
    Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0407-2022·2021-12-29

    Cataract Surgery Kits Recalled for Compromised Sterile Packaging

    Beaver Visitec is recalling Malosa Core Phaco Pack 1 cataract surgery kits (Part Number: MMK833/2) because packaging may have small holes that compromise product sterility. The recall affects 120 units distributed across nine states.

    Product
    Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK833/2
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0413-2022·2021-12-29

    Testicular Prosthesis Recalled Due to Incorrect Size Labeling

    Coloplast Manufacturing is recalling Torosa Saline-Filled Testicular Prosthesis (Size Small) due to incorrect size labeling. Nineteen units were distributed in the US and Canada.

    Product
    Torosa Saline-Filled Testicular Prosthesis (Size Small)
    Category
    Medical Device
    Distribution
    Distributed nationwide