RegWardenFDA facility compliance records
Company

COOK MEDICAL

10 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2014: 1 recalls; 2015: 1 recalls; 2017: 1 recalls; 2018: 1 recalls; 2019: 1 recalls; 2020: 1 recalls; 2022: 1 recalls; 2023: 1 recalls; 2024: 1 recalls; 2025: 1 recalls1’141’15’161’171’181’191’20’211’221’231’241’25’26
  • Recalls (10)

Registered facilities (1)

Recalls & enforcement

  • Class IOngoing2025-09-18
    Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
  • Class IIOngoing2024-04-01
    Devices may contain elevated levels of bacterial endotoxin.
  • Class IIOngoing2023-12-07
    The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static electricity) is applied to the lid of the device. This may lead to embryo degeneration necessitating an additional medical procedure for the patient.
  • Class IIITerminated2022-02-14
    IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
  • Class IITerminated2020-12-16
    A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the silicone stoppers to dislodge or gas to leak from the flasks, impeding gas flow to the incubation chambers of the Mini Incubator.
  • Class IIITerminated2019-02-25
    Updates to the Instructions for Use.
  • Class IITerminated2018-09-25
    The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
  • Class ITerminated2017-03-22
    There have been five reports of graft thrombosis/occlusion during global commercial use, each following treatment for BTAI. One case resulted in patient death, and three cases resulted in reintervention.
  • Class IITerminated2015-12-22
    Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications, and the joint may separate during deployment. Failure of this joint during a procedure may result in a partial stent deployment. The clinical effect …
  • Class IITerminated2014-09-26
    MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by Cook Medical, has initiated a voluntary recall of these products. The recall has been initiated due to customer complaints that the protective caps were dislodged in the pouch. Furt…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “COOK MEDICAL — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9090900-cook-medical/

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