Data Foundry

Medical device recalls 2026

COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number… — Class II medical device recall Z-1791-2026

Ongoing recall by Cook Incorporated, reported 2026-04-15. Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Recall numberZ-1791-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmCook Incorporated, Bloomington, IN, United States
Recall initiated2026-03-05
Classified2026-04-06
Reported by FDA2026-04-15
Quantity104 units
Reason classeslabeling
UPC / GTIN / UDI-DI00827002565371
Lot numbers15714808X, 15719344X, 15834145, 15834147
Model numbersC-UTPT-1020-WAYNE-IMH, C-UTPT-1400-WAYNE-112497-IMH, C-UTPTY-1400-WAYNE-112497-IMH

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 for recall

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1791-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.