The Recall Desk
HighFDA (Devices)·Z-1781-2026·Announced 2026-04-15

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

Pending LLM rewrite. Source: FDA_DEVICE Z-1781-2026.

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 Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115.
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-FLEX-HC
  • UDI (01)00827002320925(17)270812(10)NS16200246
  • Lot Number NS16200246
  • UDI (01)00827002320925(17)270803(10)NS16189601
  • Lot Number NS16189601
  • UDI (01)00827002320925(17)270827(10)NS16226797
  • Lot Number NS16226797
  • UDI (01)00827002320925(17)270812(10)NS16200247
  • Lot Number NS16200247
  • UDI (01)00827002320925(17)270803(10)NS16189598
  • Lot Number NS16189598
  • UDI (01)00827002320925(17)270803(10)NS16189586
  • Lot Number NS16189586
  • UDI (01)00827002320925(17)270803(10)NS16189600
  • Lot Number NS16189600
  • UDI (01)00827002320925(17)270620(10)16120672
  • Lot Number 16120672
  • UDI (01)00827002320925(17)270803(10)NS16189607
  • Lot Number NS16189607
  • Reference Part Number C-PTIS-100-HC

Distribution

Distribution scope not specified by the agency.

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