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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21001–21025 of 40248

  • HighFDA (Devices)·Z-1181-2019·2019-04-24

    Gyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk

    Gyrus ACMI is recalling 82 Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with Olympus consoles.

    Product
    Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1191-2019·2019-04-24

    Medrobotics Flex Robotic System Obturators Recalled for Weld Failure Risk

    Medrobotics is recalling 35 Flex Robotic System obturators because a weld may break, causing the rod to separate from the cone.

    Product
    Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1146-2019·2019-04-24

    Roche Lactate Gen.2 Recalled Due to Endogenous Interference Claims

    Roche Diagnostics is recalling Lactate Gen.2 reagents because new endogenous interference claims may affect test accuracy on specific analyzers.

    Product
    Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnostic reagent system intended for use on cobas Integra for the quantitative determination of the lactate concentration in plasma and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1148-2019·2019-04-24

    Bioventus Recalls Bioactive Bone Graft Putty Due to Sterility Risk

    Bioventus is recalling 10,793 units of Bioactive Bone Graft Putty because sterile pouches may puncture during transit, potentially introducing non-sterile devices and causing patient infection.

    Product
    BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Sold under the brand names of: SIGNAFUSE, OSTEOFUSE and MEDLINE UNITE.
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1184-2019·2019-04-24

    Gyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk

    Gyrus ACMI is recalling 193 Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with specific consoles.

    Product
    Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1200-2019·2019-04-24

    GE Healthcare Recalls Innova IGS 630 X-Ray Systems for Imaging Loss

    GE Healthcare is recalling 49 Innova IGS 630 Interventional Fluoroscopic X-Ray Systems due to a potential loss of x-ray imaging function when changing the field of view while releasing the footswitch.

    Product
    Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1183-2019·2019-04-24

    Gyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk

    Gyrus ACMI is recalling 13 Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with compatible consoles.

    Product
    Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1201-2019·2019-04-24

    GE Healthcare Recalls Innova IGS 6 X-Ray Systems Due to Imaging Loss

    GE Healthcare is recalling 22 Innova IGS 6 Interventional Fluoroscopic X-Ray Systems because they may lose x-ray imaging function during specific field of view changes.

    Product
    Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1139-2019·2019-04-24

    Pintler Medical Recalls 24 Warming Pads Due to Malfunction

    Pintler Medical LLC is recalling 24 warming pads used in operating rooms because they malfunction. The affected units were distributed to facilities in Wisconsin.

    Product
    A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1132-2019·2019-04-24

    Wilson-Cook Recalls Acusnare Polypectomy Snares Due to Loop Retraction Issues

    Wilson-Cook Medical Inc. is recalling 34,456 Acusnare Polypectomy Snares because the snare loop may not completely retract or may misshape.

    Product
    Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1178-2019·2019-04-24

    Olympus Diego Elite Console Recall for Unintended RF Energy Activation

    Gyrus ACMI is recalling Olympus Diego Elite Consoles because they may inadvertently activate the RF energy feature when used with specific blades.

    Product
    Olympus Diego Elite Console MDCONS 100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1177-2019·2019-04-24

    ProSun V3 42 Tanning Beds Recalled for Potential High UV Output

    ProSun International is recalling nine specific tanning beds due to quality control documentation discrepancies that could result in high UV output.

    Product
    ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the following: PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE (TMAX READY), PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE, PROSUN V3 42 HIGH INTENSIVE (160W) RED, PROSUN V3 42 HIGH INTENSIVE (160W) PEARL…
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1196-2019·2019-04-24

    Abbott Alinity i Processing Module Recalled for Safety Interlock Defect

    Abbott is recalling Alinity i Processing Modules because a safety interlock may fail to deploy when a bulk solution bottle is removed.

    Product
    Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1150-2019·2019-04-24

    Integra Salto Talaris Ankle Prosthesis Recalled for Incorrect Labeling

    Integra LifeSciences is recalling Salto Talaris and Integra XT Revision ankle implants because the labels list an incorrect metallic coating material symbol.

    Product
    Salto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right, Part No. LJU200T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1144-2019·2019-04-24

    Philips Brilliance iCT CT Scanners Recalled for Collimator Compensator Failure

    Philips is recalling two Brilliance iCT CT scanners because a component may fail, causing image artifacts. The devices were distributed only to China and the UK.

    Product
    Brilliance iCT, 728306 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1173-2019·2019-04-24

    Integra Talar Dome Total Ankle Prosthesis Recalled for Labeling Error

    Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.

    Product
    Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1138-2019·2019-04-24

    Topcon IMAGEnet 6 Software Recalled for Patient Data Display Error

    Topcon Medical Systems is recalling IMAGEnet 6 software due to a defect that may display incorrect patient identification information alongside thumbnails.

    Product
    IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices without controlling or altering the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1166-2019·2019-04-24

    Integra Talar Dome Total Ankle Prosthesis Recalled for Labeling Error

    Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.

    Product
    Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1175-2019·2019-04-24

    Integra Talar Dome Ankle Prosthesis Recalled for Incorrect Labeling

    Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.

    Product
    Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1168-2019·2019-04-24

    Integra Talar Dome Ankle Prosthesis Recalled for Incorrect Labeling

    Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels incorrectly identify the metallic coating material.

    Product
    Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1174-2019·2019-04-24

    Integra Talar Dome Ankle Prosthesis Recalled for Labeling Error

    Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels incorrectly list the metallic coating material symbol.

    Product
    Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1171-2019·2019-04-24

    Integra Talar Dome Ankle Prosthesis Recalled for Incorrect Labeling

    Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels incorrectly identify the metallic coating material.

    Product
    Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1169-2019·2019-04-24

    Integra LifeSciences Recalls Talar Dome Ankle Prostheses Due to Labeling Error

    Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.

    Product
    Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1141-2019·2019-04-24

    Philips Medical Systems Recalls Foot Switches for Allura Xper Systems

    Philips Medical Systems is recalling 7,209 foot switches used with Allura Xper systems because pedals may bend, causing an inability to make live fluoroscopy images or exposures.

    Product
    Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD10 F 722003 Allura Xper FD10 722005 Allura Xper FD10/10 722006 Allura Xper FD20 722008 Allura Xper FD20 Biplane 722010 Allura Xper FD10 722011 Allura Xper FD10/10 722012…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1135-2019·2019-04-24

    Ethicon Recalls VICRYL Plus Sutures Due to Labeling Mismatches

    Ethicon, Inc. is recalling VICRYL Plus Sutures because the product may not match the sales unit carton and foil label.

    Product
    VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 UND VICRYL PLUS SUTURE 18"(45CM) 0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 VIO) VICRYL PLUS SUTURE 18"(45CM) 1 VIO VICRYL PLUS SUTURE 18"(45CM) 4-0 VIO VICRYL PLUS SUTURE 27"(70CM) 3-0…
    Category
    Medical Device
    Distribution
    Distributed nationwide