ClearanceBrief
Recall Z-1784-2026 ยท LQR Dislodger, Stone, Biliary

Cook Incorporated

COOK MEDICAL Cook Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108

DateApr 6, 2026 (initiated Mar 5, 2026)
StatusOpen, Classified
ReasonProducts from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Root causeIncorrect or no expiration date
ActionCook Medical issued an URGENT: MEDICAL DEVICE RECALL to its consignee on 3/5 2026 via courier or email. The notice explained the issue, potential risk to health, and requested the following: Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowled
Quantity49 units
DistributionWorldwide distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K173687Strange Bile Duct Stone Exploration Set
Cook Incorporated, Dec 15, 2017