Home/Recalls/FDA-Z-1778-2026
FDA DevicesClass II

COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-1...

Published: April 15, 2026Recall ID: Z-1778-2026Category: devicesCountry: US

Reason for Recall / Hazard

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

Product Description & Identification

COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419

Affected Products

COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419

Additional Source Details

FieldValue
CityBloomington
StateIN
Event id98495
Address 1750 N Daniels Way
Code infoReference Part Number APMY-2.5-15-0-2.5, UDI (01)00827002584129(17)270212(10)15894185X, Lot Number 15894185X; Reference Part Number APMY-2.5-15-0-2.5, UDI (01)00827002584129(17)261108(10)15747314X, Lot Number 15747314X; Reference Part Number APMY-4.0-21J-1-12, UDI (01)00827002584198(17)260202(10)15264260X, Lot Number 15264260X;
Postal code47404-9120
Report date20260415
Product typeDevices
Product quantity20 units
Reason for recallProducts from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260305
Initial firm notificationTwo or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date20260406

Overview

  • Recalling FirmCook Incorporated
  • StatusOngoing
  • Risk LevelClass II
  • DistributionWorldwide distribution.
Official Agency Alert