Recall Z-1791-2026— Cook Incorporated
Class II · Ongoing
Class II FDA medical device recall by Cook Incorporated, initiated 2026-03-05. FDA's recall record names no specific 510(k) clearance for this event. Product: COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.. Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life..
- Recalling firm
- Cook Incorporated
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-05
- Firm location
- Bloomington, IN, United States
Product description
COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.
Reason for recall
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Data sourced from openFDA. This site is unofficial and independent of the FDA.