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.

Filters

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

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

11826–11850 of 13748

  • 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-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-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
  • ModerateFDA (Devices)·Z-1004-2022·2022-05-04

    IV Start Kit Convenience Kits Recalled for Manufacturing Test Validation Issue

    ROi CPS LLC is recalling 290 convenience kits containing IV Start Kits due to potential inadequacy in the validation of test methods used during manufacturing. Distribution was in Missouri.

    Product
    Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830014016, LD00199P - C Section Mother.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1006-2022·2022-05-04

    IV Start Kit convenience kits recalled for manufacturing validation defect

    ROi CPS LLC recalled 950 IV Start Kit convenience kits due to potential inadequacy in manufacturing test method validation. No injuries reported.

    Product
    Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0908-2022·2022-04-27

    Philips Respironics V60 Plus Ventilator Recalled for Electrical Circuit Failure Risk

    Philips Respironics V60 Plus Ventilators are recalled for an internal electrical circuit defect that could cause the device to stop operating. Approximately 12,145 units were affected worldwide.

    Product
    Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0927-2022·2022-04-27

    Medtronic Harmony Delivery Catheter System Recalled Over Equipment Failure Risk

    Medtronic is recalling 1,483 Harmony Delivery Catheter Systems due to potential capsule bond failure during pulmonary valve replacement procedures. The FDA has classified this as a Class I recall affecting devices distributed in the US and Canada.

    Product
    Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0909-2022·2022-04-27

    Philips Respironics V680 Ventilator May Stop Operating Due to Electrical Fault

    Philips Respironics V680 Ventilators may stop operating due to an internal electrical circuit fault. Units were distributed worldwide and across the United States.

    Product
    Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0907-2022·2022-04-27

    Philips Respironics V60 Ventilator Recalled Due to Electrical Circuit Defect

    Philips Respironics V60 ventilators are recalled due to an internal electrical circuit defect that may cause the device to stop operating. Approximately 87,138 units worldwide are affected.

    Product
    Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0961-2022·2022-04-27

    Medical device software defect causes incorrect rotation count in surgical handpiece

    Medtronic Xomed integrated power console software version 2.7.3.0 has a defect that causes the set number of rotations to mismatch the actual rotations in specific modes when used with M5 handpieces. No injuries have been reported.

    Product
    Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC300
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0959-2022·2022-04-27

    Acumed Cannulated Screws Recalled for Insufficient Axial Pullout Strength

    Acumed LLC is recalling Cannulated Screws (4.0mm x 12mm) that may not have sufficient strength to hold bone fragments together, risking fracture or joint damage.

    Product
    4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0977-2022·2022-04-27

    Artis Q zeego X-ray system recalled for inadequate cooling risk

    Siemens is recalling 38 Artis Q zeego X-ray systems nationwide due to a cooling circuit malfunction that may prevent adequate cooling of the X-ray tube, triggering automatic system shutdown.

    Product
    Artis Q zeego, Model Number 10848283
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0986-2022·2022-04-27

    Diagnostic imaging system software malfunction may interrupt clinical procedures

    Siemens is recalling 35 Artis icono floor diagnostic imaging systems due to five potential software errors affecting equipment movements and detector control. The defects may limit functionality during procedures and could delay clinical treatment until the system is restarted.

    Product
    Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0960-2022·2022-04-27

    HUNTLEIGH Disposable Intraoperative Probe recalled for detachable faceplate

    Huntleigh Healthcare Ltd. is recalling 150 HUNTLEIGH Disposable Intraoperative Probes (8MHz) because the faceplate may become detached from the probe body during use.

    Product
    HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0963-2022·2022-04-27

    Sight OLO Blood Analysis Device: Incorrect Reference Ranges May Display

    The Sight OLO blood analysis device may display and print incorrect reference ranges in software versions 2.59.3 and earlier. This could occur when custom reference ranges were configured after device installation.

    Product
    The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0962-2022·2022-04-27

    CT Scanner Software Error May Cause Scanning Interruptions and Unexpected Radiation

    Siemens SOMATOM CT scanners with software syngo CT VA30A_SP4 may experience sporadic software errors causing scanning interruptions and potential unexpected radiation doses. 547 units affected nationwide.

    Product
    SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0947-2022·2022-04-27

    Matrix COVID-19 Test Kits Recalled for Unauthorized Home Sample Collection

    Matrix Medical Network is recalling 3,226 At-Home COVID-19 Test kits distributed across 24 U.S. states because the tests were not authorized by the FDA for home sample collection.

    Product
    Matrix Clinical Solution At-Home COVID-19 Test
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0973-2022·2022-04-27

    Artis zeego X-ray imaging system recalled for insufficient cooling

    Siemens is recalling 183 Artis zeego X-ray imaging systems due to a cooling system defect that may prevent adequate X-ray tube cooling, triggering automatic system shutdown.

    Product
    Artis zeego, Model Number 10280959
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2022·2022-04-27

    Medical device X-ray imaging system recalled for cooling failure

    Siemens Medical Solutions is recalling its Artis Q.zen X-ray imaging system due to a coolant circulation defect that may cause insufficient tube cooling and system shutdown.

    Product
    Artis Q.zen floor, Model Number 10848353
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0975-2022·2022-04-27

    X-ray Imaging System Coolant Deficiency May Disable Equipment Operation

    The Artis Q X-ray system may fail to adequately cool the X-ray tube if coolant levels drop, causing the system to disable imaging and display error messages. 418 systems are affected nationwide.

    Product
    Artis Q ceiling, Model Number 10848281
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0945-2022·2022-04-27

    Acon Biotech Flowflex COVID-19 Rapid Test Recalled for Inaccurate Results

    Acon Biotech is recalling Flowflex SARS-CoV-2 Antigen Rapid Tests because the non-EUA authorized kits may produce inaccurate results, including false negatives or false positives.

    Product
    Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0974-2022·2022-04-27

    Artis Q floor X-ray system cooling failure poses overheating risk

    Siemens is recalling 80 Artis Q floor X-ray systems nationwide due to a cooling circuit failure that may cause insufficient cooling of the X-ray tube, resulting in automatic system shutdown.

    Product
    Artis Q floor, Model Number 10848280
    Category
    Medical Device
    Distribution
    Distributed nationwide