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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12551–12575 of 39988

  • HighFDA (Devices)·Z-1021-2022·2022-05-11

    In Vitro Diagnostic Estradiol Test Recalled for Falsely Elevated Results

    Siemens Healthcare Diagnostics is recalling Atellica IM Enhanced Estradiol (eE2) 500T diagnostic kits that produce falsely elevated test results in plasma specimens, which could lead clinicians to misinterpret patient results.

    Product
    Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1029-2022·2022-05-11

    Robotic-Assisted Medical Device Recalled Due to Software Defect

    The FDA is recalling the VELYS Robotic-Assisted Solution Base due to a software defect in version 1.5.1 related to Daylight Saving Time changes. The defect can cause system errors requiring restart, potentially delaying patient treatment.

    Product
    VELYS Robotic-Assisted Solution Base Product No.: 451570100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1024-2022·2022-05-11

    Siemens ADVIA Centaur Estradiol Test Recalled for Falsely Elevated Results

    Siemens Healthcare is recalling all lots of the ADVIA Centaur Enhanced Estradiol diagnostic test because plasma specimens can produce falsely elevated results, potentially leading clinicians to misinterpret patient results.

    Product
    ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1020-2022·2022-05-11

    Estradiol diagnostic test kits recalled for falsely elevated results

    Siemens Atellica IM Enhanced Estradiol test kits can produce falsely elevated results in plasma specimens, potentially leading to misinterpretation of patient hormone measurements. Approximately 2,044 units worldwide are affected.

    Product
    Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1025-2022·2022-05-11

    Estradiol Diagnostic Device Recalled for Falsely Elevated Test Results

    An estradiol diagnostic device has been recalled because it produces falsely elevated test results in plasma specimens. These inaccurate results could cause clinicians to misinterpret patient test results.

    Product
    ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1019-2022·2022-05-11

    Baxter Flo-Thru Intraluminal Shunt Recall for Potential Foreign Matter

    Baxter Healthcare is recalling Flo-Thru Intraluminal Shunts due to potential foreign matter contamination. The recall involves 300 devices distributed in the U.S. and internationally.

    Product
    Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1026-2022·2022-05-11

    Cervical Cage Trial Kit Recalled for Incorrect Size Labeling

    restor3d Inc. is recalling 14 units of its Non-Sterile Double Ended Trial Kit because the product was labeled as Small Footprint when it is actually Medium. The lot was distributed nationwide across seven states.

    Product
    Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • SevereFDA (Devices)·Z-0953-2022·2022-05-04

    Celltrion DiaTrust COVID-19 Rapid Test distributed to unqualified facilities

    Celltrion USA Inc. is recalling Celltrion DiaTrust COVID-19 Ag Rapid Test kits distributed to facilities without valid CLIA certification. The tests were distributed nationwide from December 2021 through February 2022.

    Product
    Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
    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-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-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-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-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-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-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-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-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-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
    32 states
  • 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-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
  • 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