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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11776–11800 of 13717

  • SevereFDA (Devices)·Z-0999-2022·2022-05-04

    Surgical Stapler: da Vinci SureForm Recalled for Tissue Pushout and Bleeding

    Intuitive Surgical recalled SureForm surgical staplers after tissue pushout events caused unexpected bleeding during procedures. The actual harm rate exceeded safety predictions.

    Product
    da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform 60 REF 480460
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0966-2022·2022-05-04

    Ventilator Audible and Visual Alarms May Not Activate During Alarm States

    The Puritan Bennett 980 Series Ventilator may fail to sound its audible alarm or display its visual alarm during critical alarm states, potentially delaying treatment response.

    Product
    Puritan Bennett 980 Series Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1003-2022·2022-05-04

    SpaceOAR Vue System Recalled for Embolism Risk from Misplacement

    The SpaceOAR Vue System implant used in prostate cancer radiotherapy is being recalled because improper hydrogel placement can cause embolism. Boston Scientific has updated instructions and warnings to prevent misplacement.

    Product
    SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1005-2022·2022-05-04

    IV Start Kit Convenience Kits Recalled for Inadequate Test Method Validation

    ROi CPS LLC is recalling 1,501 convenience kits containing regard IV Start Kits due to inadequate validation of manufacturing test methods. Products were distributed in Missouri.

    Product
    Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830084003, LD00866C - Vag Delivery Mother.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0998-2022·2022-05-04

    Medtronic InterStim Clinician Software Has Data Loss Anomaly Affecting Patient Information

    The InterStim X Clinician software used to program urinary incontinence therapy has a software bug that causes patient information to be lost and display a 'Data Lost' notification.

    Product
    MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) InterStim X Clinician Therapy Application Software, Model Number A51300; and c) Inte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1000-2022·2022-05-04

    NeuMoDx COVID-19 test cartridges recalled for false positive risk

    NeuMoDx Molecular is recalling diagnostic cartridges used in COVID-19 and flu/RSV tests because of potential for false positive SARS-CoV-2 results, which could lead to incorrect patient management.

    Product
    NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx SARS CoV-2 Test Strip (REF 300800) NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip (REF 300900) NeuMoDx Laboratory Developed Tests (LDTs) for SARS-Co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1002-2022·2022-05-04

    Boston Scientific SpaceOAR System Embolism Risk from Hydrogel Misplacement

    FDA recalls Boston Scientific's SpaceOAR System due to risk of embolism from incorrect hydrogel placement during prostate cancer radiotherapy. Updated instructions provide verification steps for proper placement.

    Product
    SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0993-2022·2022-05-04

    PrisMax System software anomaly affects therapy parameter settings

    The PrisMax System has a software defect that can silently revert custom therapy parameters to defaults when using the Same Patient function without notifying the operator.

    Product
    PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0996-2022·2022-05-04

    CT scanner software upgrade causes incorrect laser position display

    Siemens CT scanner software upgrade may display incorrect laser offset coordinates during patient marking. This defect affects 15 systems in the US across multiple states.

    Product
    syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Number 11061660. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1014-2022·2022-05-04

    ACL TOP Laboratory Analyzer Carryover Contamination May Affect Test Results

    Instrumentation Laboratory recalls ACL TOP coagulation analyzers due to potential carryover contamination that may cause inaccurate anticoagulation test results. When specific reagents are used together, tests for heparin, apixaban, and rivaroxaban may show elevated results.

    Product
    ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished) 3. ACL TOP 350 CTS 00000280065 4. ACL TOP 500 CTS 00000280040 5. ACL TOP 500 CTS 00000280040R ( Refurbished) 6/ 6. ACL TOP 55
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1001-2022·2022-05-04

    TearCare Version 1.0 SmartHubs Recalled for Lack of FDA Premarket Evaluation

    Sight Sciences is recalling 921 TearCare version 1.0 SmartHubs ophthalmic devices distributed nationwide because they were distributed prior to FDA 510(k) clearance without premarket evaluation of their performance characteristics.

    Product
    TearCare version 1.0 SmartHubs
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1017-2022·2022-05-04

    Empower Introducer Sheath recalled for potential embolism and ischemia risk

    Freudenberg Medical is recalling Empower Introducer Sheath devices (Model 668782-200) due to potential adhesive residue inside the catheter shaft that may cause blood clots and tissue damage. Affected devices were distributed in the US and Netherlands.

    Product
    Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1013-2022·2022-05-04

    WAVES WCM Kidney Cassette Module Recalled for Potential Pump Head Leaking

    Waters Medical Systems LLC is recalling WAVES WCM Kidney Cassette Modules due to a potential for the pump head to leak solution. The recall affects medical facilities in Tennessee and France.

    Product
    WAVES WCM Kidney Cassette Module
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1016-2022·2022-05-04

    Empower Introducer Sheath Recalled for Defective Glue and Embolism Risk

    Freudenberg Medical is recalling the Empower Introducer Sheath due to defective adhesive on the catheter shaft that could cause blood clots and tissue damage.

    Product
    Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1010-2022·2022-05-04

    Acuson 9vE4 Ultrasound Transducers Recalled for Potential Thermal Injury Risk

    Siemens is recalling 31 Acuson 9vE4 ultrasound transducers that may exceed thermal index limits, creating a potential risk of thermal injury. Affected units were distributed in US states and international locations.

    Product
    Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1015-2022·2022-05-04

    IMMULITE 2000 hCG diagnostic systems recalled for falsely elevated results

    Siemens Healthcare is recalling IMMULITE 2000 hCG diagnostic systems due to potential sample carryover that could produce falsely elevated hCG test results.

    Product
    IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0995-2022·2022-05-04

    CT Scanner Software Update May Display Incorrect Laser Offset Coordinates

    Siemens CT scanner software upgrade may cause incorrect laser offset coordinates to display during patient positioning. No injuries reported.

    Product
    syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0994-2022·2022-05-04

    Radiation therapy software update displays incorrect laser positioning

    Siemens syngo.via RT imaging software upgraded to VB60 automatically modifies laser configuration, potentially displaying incorrect laser offset coordinates during radiation therapy patient marking.

    Product
    syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1008-2022·2022-05-04

    Diabetes Management Software May Display Wrong Patient Data

    Roche Diabetes Care Platform Software version 2.5.2 may display incorrect patient data when users navigate between patient records using the browser back button. No illnesses have been reported.

    Product
    RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosted on a server. There is no physical product.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1007-2022·2022-05-04

    ZEISS miLOOP Lens Fragmentation Device Recalled for Slider Friction Issue

    Carl Zeiss Meditec is recalling the ZEISS miLOOP Lens Fragmentation Device due to high friction in the slider mechanism that may cause it to stick or fail to move as intended during cataract surgery.

    Product
    ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-1012-2022·2022-05-04

    Drager Infinity CentralStation Software Temporary Monitoring Functionality Loss

    Drager is recalling Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12 due to a temporary loss of central monitoring functionality. The software is used for patient monitoring with wireless telemetry devices.

    Product
    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1011-2022·2022-05-04

    Smart Toe II Surgical Implant Recalled: Obscured Nickel Warning Label

    Stryker GmbH recalls 246 Smart Toe II orthopedic implants due to label obstruction that obscures the nickel-sensitivity contraindication, potentially allowing inappropriate use.

    Product
    Smart Toe II Intramedullary Arthrodesis Implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0997-2022·2022-05-04

    CT Scanner Software Update May Display Incorrect Laser Positioning Coordinates

    Siemens CT scanner imaging software upgraded to version VB60 may display incorrect laser offset coordinates during patient marking. Fourteen units are affected in the United States.

    Product
    syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0992-2022·2022-05-04

    PrisMax System software causes unalerted treatment parameter reversion

    The PrisMax System may revert custom treatment parameters to default values without notifying the operator when the Same Patient function is used. This could cause patients to receive unintended treatment settings.

    Product
    PrisMax System, Product Code 955724
    Category
    Medical Device
    Distribution
    Distributed nationwide