The Recall Desk
HighFDA (Devices)·Z-1777-2026·Announced 2026-04-15

[pending] COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G5

Pending LLM rewrite. Source: FDA_DEVICE Z-1777-2026.

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 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
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 (8)

  • Reference Part Number CMW-14-190-18G
  • UDI (01)00827002507883(17)290214(10)15898546X
  • Lot Number 15898546X
  • UDI (01)00827002507883(17)270115(10)15660224
  • Lot Number 15660224
  • Reference Part Number CMW-14-300-18G
  • UDI (01)00827002507920(17)260718(10)15220204
  • Lot Number 15220204.

Distribution

Distribution scope not specified by the agency.