The Recall Desk
HighFDA (Devices)·Z-1780-2026·Announced 2026-04-15

[pending] COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number

Pending LLM rewrite. Source: FDA_DEVICE Z-1780-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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

The recalled product

Product
COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704
Manufacturer
Cook Incorporated

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

  • Reference Part Number C-PTISY-100-HC-G-NA
  • UDI (01)00827002577039(17)270730(10)16183353X
  • Lot Number 16183353X
  • UDI (01)00827002577039(17)270524(10)16076948
  • Lot Number 16076948
  • UDI (01)00827002577039(17)260222(10)15473203X
  • Lot Number 15473203X
  • UDI (01)00827002577039(17)260201(10)15476984X
  • Lot Number 15476984X
  • UDI (01)00827002577039(17)261020(10)15719188X
  • Lot Number 15719188X
  • Reference Part Number C-PTISY-100-UNL-HC-G-NA
  • UDI (01)00827002577060(17)270814(10)16205108
  • Lot Number 16205108
  • Reference Part Number C-PTISY-100-UNS-HC-G-NA
  • UDI (01)00827002577046(17)270528(10)16080161X
  • Lot Number 16080161X
  • UDI (01)00827002577046(17)270901(10)16435112
  • Lot Number 16435112.

Distribution

Distribution scope not specified by the agency.