The Recall Desk
HighFDA (Devices)·Z-1783-2026·Announced 2026-04-15

Cook Medical Spectrum central venous catheter trays carry overstated expiration dates

Cook Medical is recalling custom Spectrum Central Venous Catheter Trays because affected lots were labeled with expiration dates that exceed the true shelf life. 1,872 units are affected.

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: FDA Class II recall where an overstated expiry date can lead to use of a sterile device beyond its validated shelf life, a risk of harm with no injuries reported.

Plain-English summary

Cook Medical is recalling the Spectrum Central Venous Catheter Tray across several custom reference part numbers, including C-UTLMY-701J-ABRM-CUSTOM-0003, -0018 and -0042, as listed in the recall notice. The action covers 1,872 units.

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life of the product. A tray carrying an overstated expiry can be held and used after the point at which its sterility and performance were validated. The FDA classified the action as Class II.

Distribution was worldwide. The trays are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the reference part numbers and lot numbers in the recall notice, quarantine it, and follow the instructions issued by Cook Medical.

The recalled product

Product
COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Number G21053; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, Order Number G3
Manufacturer
Cook Incorporated
Category
Medical Device — Central venous catheter tray
Hazard
Affected units
1,872

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-UTLMY-701J-ABRM-CUSTOM-0003
  • UDI (01)00827002564244(17)261130(10)16288039
  • Lot Number 16288039
  • Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018
  • UDI (01)00827002210530(17)260430(10)16029543
  • Lot Number 16029543
  • Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042
  • UDI (01)00827002349148(17)260228(10)15681111
  • Lot Number 15681111
  • UDI (01)00827002349148(17)260228(10)15646726
  • Lot Number 15646726
  • UDI (01)00827002349148(17)260228(10)15721094
  • Lot Number 15721094
  • UDI (01)00827002349148(17)260131(10)15620729
  • Lot Number 15620729
  • UDI (01)00827002349148(17)260131(10)15583884
  • Lot Number 15583884
  • UDI (01)00827002349148(17)251231(10)15518185
  • Lot Number 15518185
  • UDI (01)00827002349148(17)251231(10)15473132

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 18 recalled by Cook Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 18 products in this recall →

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Same hazard · expiration date error

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