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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13176–13200 of 40151

  • HighFDA (Devices)·Z-0444-2022·2022-01-05

    Catalys Precision Laser System recalled for remote code execution vulnerability

    AMO Manufacturing is recalling Catalys Precision Laser Systems due to a Windows Print Spooler vulnerability that could allow unauthorized remote code execution with system privileges.

    Product
    Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and Catalys Precision Laser System No Bed, Models: 0160-6020 (United States), 0160-6010 (International)
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0420-2022·2022-01-05

    Ultimum Hemostasis Introducer devices recalled due to manufacturing error

    Abbott is recalling one lot of Ultimum Hemostasis Introducer devices due to a manufacturing error that resulted in incorrect hub and length. Affected devices are 12 cm long instead of the intended 5 cm.

    Product
    Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0437-2022·2022-01-05

    VIDAS Lyme diagnostic test device recalled due to substrate error

    bioMerieux recalled VIDAS Lyme IgG II test devices (two lots) due to a substrate error that prevents tests from running. Users must retest patients, potentially delaying Lyme disease diagnosis.

    Product
    VIDAS Lyme IgG II (LYM), REF 417401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0423-2022·2022-01-05

    Speech Generation Device Charging Components Recalled for Fire and Electric Shock Hazard

    Forbes Rehab Services is recalling Monoprice charging cables and iClever charging bricks for ProSlate Speech Generation Devices due to fire and electric shock risks if cables are damaged or charging occurs near moisture.

    Product
    Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for the SoundPOD Bluetooth Speaker accessory to the ProSlate Speech Generation Devices (including Proslate 13: B398PS130; Proslate 10: B398PS100…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0429-2022·2022-01-05

    VIDAS Mumps IgG diagnostic test kit recalled due to substrate error

    bioMerieux is recalling one lot of VIDAS Mumps IgG diagnostic tests because a substrate error prevents the tests from running, causing delays.

    Product
    VIDAS Mumps IgG (MPG), REF 30218
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0428-2022·2022-01-05

    VIDAS procalcitonin diagnostic test substrate error causes testing delays

    Nationwide recall of VIDAS procalcitonin test kits for substrate defects that prevent testing and require retesting, potentially delaying diagnostic results.

    Product
    VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0435-2022·2022-01-05

    VIDAS Estradiol II Test Device Recalled Due to Substrate Error

    bioMerieux is recalling one lot of VIDAS Estradiol II diagnostic test devices due to a substrate error that prevents tests from running, causing delayed results and requiring repeat testing.

    Product
    VIDAS Estradiol II, REF 30431-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0439-2022·2022-01-05

    VIDAS SARS-COV-2 Diagnostic Test Recalled for Substrate Error

    bioMerieux is recalling two lots of VIDAS SARS-COV-2 IgG diagnostic tests due to substrate errors that prevent test execution, requiring users to repeat testing and potentially delaying results.

    Product
    VIDAS SARS-COV-2 IgG, Ref 423834-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0430-2022·2022-01-05

    VIDAS Measles IgG Test Kit Recalled Due to Substrate Error

    bioMerieux is recalling VIDAS Measles IgG test kits due to a substrate error that prevents the test from running, requiring users to repeat testing and potentially delaying results.

    Product
    VIDAS Measles IgG (MSG), REF 30219
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0433-2022·2022-01-05

    VIDAS LH diagnostic test substrate error causes delayed results

    bioMerieux VIDAS LH test kits (lot 1008848600) are affected by a substrate error that prevents test execution, requiring users to repeat testing and potentially delaying results.

    Product
    VIDAS LH, REF 30406-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0431-2022·2022-01-05

    Diagnostic test kit recalled due to substrate error preventing test execution

    A diagnostic test kit manufactured by bioMerieux has been recalled because a substrate error prevents the test from running, which delays test results for patients.

    Product
    VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0427-2022·2022-01-05

    Diagnostic substrate error in medical testing device causes test failures

    bioMerieux is recalling 1,579 VIDAS DEX@ diagnostic devices due to substrate errors that prevent test execution, requiring users to rerun tests and potentially delaying results.

    Product
    VIDAS DEX@, Dimer Exclusion II, REF 30455-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0422-2022·2022-01-05

    Diagnostic device recall: incorrect color in package insert reading table

    Biomerieux is recalling RAPID 20 E diagnostic systems because the package insert contains an incorrect color for interpreting negative CIT test results.

    Product
    RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • ModerateFDA (Devices)·Z-0436-2022·2022-01-05

    VIDAS Lyme IgM II Diagnostic Test Kits Recalled for Substrate Error

    bioMerieux is recalling three lots of VIDAS Lyme IgM II diagnostic test kits due to a substrate error that prevents the test from running, requiring users to conduct another test to obtain results.

    Product
    VIDAS Lyme IgM II (LYM), REF 416436
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0432-2022·2022-01-05

    VIDAS RUB IgG Diagnostic Test Kit Recalled for Substrate Defect

    bioMerieux is recalling three lots of VIDAS RUB IgG test kits due to substrate errors that prevent the test from running, potentially delaying diagnostic results.

    Product
    VIDAS RUB IgG (RBG), REF 30226
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0424-2022·2022-01-05

    FDA Recalls VIDAS PRG Progesterone Test Kits for Substrate Error

    bioMerieux is recalling 1,818 units of VIDAS PRG Progesterone test kits due to a substrate error that prevents the tests from running properly, causing delayed results when patients need repeat testing.

    Product
    VIDAS PRG Progesterone, REF 30409-01
    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-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-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-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-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-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