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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

12451–12475 of 13816

  • HighFDA (Devices)·Z-0419-2022·2022-01-05

    da Vinci SP Surgical System Software Energy Delivery Defect

    Intuitive Surgical recalls 46 da Vinci SP Surgical systems due to software defect causing potential failure or inadvertent delivery of surgical energy. Issue may require surgeon intervention during procedures.

    Product
    da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735 ASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742 SOFTWARE, SYSTEM EMBEDDED RLS, SP1098, B70_P4_B327 (OS4 v4.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0440-2022·2022-01-05

    Siemens Atellica CH β2-Microglobulin Assay Lot 211446 Recalled for Measurement Bias

    Siemens Healthcare Diagnostics recalled lot 211446 of the Atellica CH β2-Microglobulin assay due to analytical bias in test results. The assay showed positive bias up to 20.9% at some concentrations and negative bias up to 10.5% at others.

    Product
    Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma Siemens Material Number (SMN): 11097635
    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-0426-2022·2022-01-05

    VIDAS Clostridium Difficile GDH test substrate error causes test failure

    bioMerieux recalls VIDAS Clostridium Difficile GDH diagnostic test kits due to a substrate error that prevents test execution. Affected users must retest samples, potentially delaying results.

    Product
    VIDAS Clostridium Difficile GDH, REF 30125-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0441-2022·2022-01-05

    Cancer treatment linear accelerator systems recalled for wrong-site dosing risk

    Siemens recalled 13 ARTISTE linear accelerator systems for cancer treatment due to a potential safety issue that could cause radiation to be delivered to the wrong treatment site.

    Product
    ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815
    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-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
  • 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-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-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-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
  • 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
  • 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
  • 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-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-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-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-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-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-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