The Recall Desk
HighFDA (Devices)·Z-1779-2026·Announced 2026-04-15

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

Pending LLM rewrite. Source: FDA_DEVICE Z-1779-2026.

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 Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Refer
Manufacturer
Cook Incorporated
Category
Medical Device — Devices

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 (20)

  • Reference Part Number C-PTIS-100-HC-G-EU
  • UDI (01)00827002576858(17)270802(10)16189446
  • Lot Number 16189446
  • UDI (01)00827002576858(17)270803(10)16189593
  • Lot Number 16189593
  • UDI (01)00827002576858(17)270725(10)16175956
  • Lot Number 16175956
  • UDI (01)00827002576858(17)270725(10)16175957
  • Lot Number 16175957
  • UDI (01)00827002576858(17)270803(10)16189597
  • Lot Number 16189597
  • UDI (01)00827002576858(17)270725(10)16175953
  • Lot Number 16175953
  • UDI (01)00827002576858(17)271001(10)16460934
  • Lot Number 16460934
  • Reference Part Number C-PTIS-100-HC-G-NA
  • UDI (01)00827002576827(17)280318(10)16514949
  • Lot Number 16514949
  • UDI (01)00827002576827(17)270725(10)16175948
  • Lot Number 16175948

Distribution

Distribution scope not specified by the agency.

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