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COOK INCORPORATED · Model G14936 · UDI-DI 00827002149366

FFL Prescription
10
510(k) clearances
6,077
Adverse events (5 deaths)
10
Recalls
104
Facilities

Description

Rat Tooth Forceps

Recalls

DateFirmReason
2023-06-22Wilson-Cook Medical Inc.Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical litho
2023-06-22Wilson-Cook Medical Inc.Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical litho
2022-02-07Philips North America, LLCUpdate to instructions for use regarding the cleaning and disinfection process for the reusable probes.
2014-10-07C.R. Bard, Inc.The product is non-sterile.
2008-08-08Sterilmed IncSteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility e
2005-12-20Boston Scientific CorpThe basket wire assembly may detach from the drive wire while in the patient.
2005-12-20Boston Scientific CorpThe basket wire assembly may detach from the drive wire while in the patient.
2004-10-27Cardinal HealthThe dispenser box was mislabeled with the wrong length and the wrong wire gauge.
2003-12-22C.R. Bard, Inc., Urological DivisionProduct packaging may contain holes compromising sterility.
2003-12-22C.R. Bard, Inc., Urological DivisionProduct packaging may contain holes compromising sterility.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.