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

Agency

Category

Minimum severity

Clear filters

9901–9925 of 27470

  • HighFDA (Devices)·Z-1128-2022·2022-06-01

    Medtronic Percept BrainSense Neurostimulator Cannot Communicate with Programmer Systems

    Medtronic is recalling 14,164 Percept BrainSense Implantable Neurostimulators (Model B35200) worldwide because the devices cannot communicate with clinical or patient programmer systems, preventing proper device monitoring and adjustment.

    Product
    Percept BrainSense Implantable Neurostimulator (INS), Model B35200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1121-2022·2022-06-01

    Unclearred VerifyNow P2Y12 Platelet Test Variant Distributed to Healthcare Providers

    Accriva Diagnostics distributed an unclearred variant of the VerifyNow P2Y12 platelet test that displays different results than the FDA-cleared device. A correction formula has been provided to healthcare providers.

    Product
    The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include ticagrelor and the thienopyridine class of drugs, including clopidogrel and prasugrel.1-8 The test is based upon the ability of acti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1137-2022·2022-06-01

    Progenamatrix Human Keratin Matrix Recalled for Inadequate Pouch Seal

    ProgenaCare is recalling progenamatrix Human Keratin Matrix due to inadequate inner pouch seals that may compromise sterility. The recall affects 547 packages distributed in Alabama, Georgia, Florida, Tennessee, and Texas.

    Product
    progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM3004, 4 x 4 cm; PM3006, 6 x 6 cm; and PM3010, 10 x 10 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1134-2022·2022-06-01

    SUR-FIT Natura Durahesive Wafer Recalled for Skin Barrier Delamination

    ConvaTec is recalling 600 market units of SUR-FIT Natura S4S Durahesive Wafer due to skin barrier delamination. The wafer's layers or tape borders may fail to maintain proper seal, potentially affecting skin protection.

    Product
    SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1127-2022·2022-06-01

    Teleflex Breathing Tubes Recalled Due to Reports of Tearing

    Teleflex Medical Inc is recalling four models of breathing tubes following reports of torn corrugated tubes. Approximately 290,809 units are affected worldwide.

    Product
    (1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, sterile; (3) Teleflex Smooth-Flo Flex with Double Swivel, Product #22512, non-sterile; (4) Teleflex Smooth-Flo Flex, Product #22552, non-sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1135-2022·2022-06-01

    Medical beds with motorized wheels face uncontrolled motion risk

    Umano Medical recalls 228 adjustable hospital beds due to potential electrical system failure that could cause uncontrolled movement of the motorized wheel system.

    Product
    AC-powered adjustable medical beds with built-in electric DC actuators and controls.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1131-2022·2022-06-01

    Medtronic Cardioblate Gemini-s Surgical Ablation System Recalled for Fractured Jaw Tips

    Medtronic is recalling 1,236 units of the Cardioblate Gemini-s surgical ablation system due to an increase in complaints about fractured jaw tips. The device is used in cardiac ablation procedures worldwide.

    Product
    Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 carton per box.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1132-2022·2022-06-01

    Surgical Suture Kit Recalled for Uncertain Sterile Barrier Integrity

    Stradis Healthcare is recalling 7,340 units of Surgical Suture Kit due to uncertainty about sterilization methods that ensure sterile barrier integrity. Affected lots should not be used.

    Product
    Surgical Suture Kit
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-1077-2022·2022-05-25

    FDA Recalls iCast Covered Stent System Due to Device Separation During Delivery

    Atrium Medical is recalling the iCast Covered Stent System because the balloon or catheter hub may separate from the delivery catheter during use, potentially causing blood clots, vessel blockages, or organ damage.

    Product
    iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 85409 85410 85411 85412 85413 85414 85415 85416 85417 85418 85419 85420 85424 85440 85441 85442 85443 85444 85445 85450 85451 85452 85453
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1032-2022·2022-05-25

    Avanos Cortrak 2 Enteral Access System Anonymous Account Mode Discontinued

    Avanos Medical is modifying labeling for the Cortrak 2 Enteral Access System and discontinuing the Anonymous Account Mode feature. Users must confirm tube placement per institutional protocol.

    Product
    Avanos Cortrak 2 Enteral Access System (EAS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1095-2022·2022-05-25

    Dragonfly OpStar Imaging Catheter Recall Due to Proximal Marker Separation Risk

    Abbott Vascular recalls 14,544 Dragonfly OpStar Imaging Catheters due to potential separation of the proximal marker. The affected devices were distributed throughout the US and internationally.

    Product
    Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-1076-2022·2022-05-25

    Atrium Advanta V12 Covered Stent System Recalled for Delivery Catheter Separation

    Atrium Medical is recalling the Advanta V12 Covered Stent System worldwide for potential separation of the balloon or catheter hub during withdrawal, which may cause procedural delays and serious complications including embolism and organ infarction.

    Product
    Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 85331 85332 85333 85334 85335 85336 85337 85338 85339 85340 85341 85342 85343 85344 85345 85350 85351 85352 85353 85354 85355 85360
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1085-2022·2022-05-25

    Medical diagnostic instrument recalled for electrical connector assembly defect

    Beckman Coulter is recalling 40 DxM 1040 MicroScan WalkAway laboratory instruments due to an assembly defect: some units have an AC power connector inlet rated at 1 ampere instead of the correct 10-ampere rating, which could impair power delivery.

    Product
    DxM 1040 MicroScan WalkAway Instrument REF B1018-440
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1111-2022·2022-05-25

    Turbett Surgical Container TS1500 weld failures breach sterile barrier

    The Turbett Surgical Container TS1500 is being recalled because eight units manufactured before June 2019 have exhibited weld failures that breach the sterile barrier during prolonged use.

    Product
    Turbett Surgical Container, TS1500
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1091-2022·2022-05-25

    ATLAS Stim Headbox Recalled: Unapproved Investigational Device Without Safety Testing

    Neuralynx is recalling the ATLAS Stim Headbox, a neurophysiology device distributed without FDA investigational approval or electrical safety clearance.

    Product
    ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United States) law to investigational use. Only for use in Non-Significant Risk studies under the supervision of an IRB.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1113-2022·2022-05-25

    FDA Recalls VITROS Immunodiagnostic LH Reagent Pack for measurement imprecision

    Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products LH Reagent Pack due to low-end imprecision that may produce falsely high or delayed patient and quality control results.

    Product
    VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1114-2022·2022-05-25

    VITROS Prolactin Reagent Recalled for Low-End Measurement Imprecision

    Ortho-Clinical Diagnostics is recalling VITROS Prolactin Reagent packs due to low-end measurement imprecision that may cause falsely high or delayed test results. Approximately 1,767 affected units are distributed worldwide.

    Product
    VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1079-2022·2022-05-25

    FDA Updates EXALT Duodenoscope Instructions for Known Perforation Risk

    Boston Scientific's EXALT Model D duodenoscope is subject to updated use instructions addressing a known risk of perforation. The FDA requires updated guidance on insertion and removal procedures.

    Product
    EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1082-2022·2022-05-25

    EXALT Model D Single-Use Duodenoscope: Updated Instructions for Perforation Risk

    Boston Scientific issued updated instructions for the EXALT Model D Single-Use Duodenoscope to highlight the known risk of perforation and provide best practices for safe insertion, advancement, and removal.

    Product
    EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1104-2022·2022-05-25

    HeartWare Ventricular Assist Device controller has translation errors in Finnish, Turkish

    HeartWare Ventricular Assist Device controllers in Finland and Turkey contain translation errors in displays, instructions, and patient manuals. The errors could affect proper device operation and emergency response.

    Product
    HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1117-2022·2022-05-25

    Portable Oxygen Concentrator Recalled for Lack of FDA Clearance

    Caire, Inc. is recalling two CAIRE FreeStyle Comfort portable oxygen concentrators because they were not cleared by the FDA for U.S. distribution. The affected devices were distributed to Puerto Rico.

    Product
    CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1083-2022·2022-05-25

    MicroScan WalkAway-40 plus Instrument recalled for incorrect AC power connector

    Beckman Coulter is recalling 22 MicroScan WalkAway-40 plus Instruments with an AC power entry connector rated at 1 ampere instead of the correct 10 amperes, creating a potential electrical hazard.

    Product
    MicroScan WalkAway-40 plus Instrument REF B1018-283
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1112-2022·2022-05-25

    VITROS Immunodiagnostic Hormone Reagents Recalled for Measurement Imprecision

    Specific lots of VITROS FSH, LH, and Prolactin reagent kits may produce falsely high or delayed test results at low measurement levels. Affected lots distributed worldwide; labs should discontinue use and contact the manufacturer.

    Product
    VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
    Category
    Medical Device
    Distribution
    Distributed nationwide