FDA-Device2026-04-15Class IIMISBRANDING
Cook Medical Wayne Pneumothorax Set recalled for incorrect expiration dates
EXPIRATION DATE ERRORNationwide distribution
Check Cook Medical pneumothorax kit expiration date
Cook Medical's Wayne Pneumothorax Set (certain lot numbers) was labeled with expiration dates that go beyond when the device is actually safe to use. This affects 104 units distributed worldwide. No injuries have been reported.
- Check if you have a Cook Medical Wayne Pneumothorax Set with lot numbers 15719344X, 15714808X, 15834145, or 15834147
- Do not use the device past its true shelf life, which is earlier than the label states
- Contact Cook Medical or your supplier for guidance on replacement or disposal
- Verify the lot number on the package before use
Hazard
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Sold states
Worldwide distribution.
Affected count
104 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1791-2026More Cook Incorporated recalls
- FDA-Device2026-04-15Cook Medical arterial pressure monitoring trays recalled for incorrect expiration dates
- FDA-Device2026-04-15Cook Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set recalled for incorrect expiration dates
- FDA-Device2026-04-15Cook Medical Strange Bile Duct Stone Exploration Set recalled for incorrect expiration dates
- FDA-Device2026-04-15Cook Medical Blue Rhino G2 tracheostomy introducer tray recalled for incorrect expiration dates
- FDA-Device2026-04-15COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief