HIGH

Cook Medical Arterial Pressure Monitoring Tray Recalled Over Expired Shelf-Life Labeling (Z-1778-202

Cook Medical recalled 20 arterial pressure monitoring trays worldwide after labeling showed expiration dates that exceeded true shelf life. The recall targets two reference part numbers, APMY-2.5-15-0-2.5 and APMY-4.0-21J-1-12. Healthcare providers should stop using affected lots immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date
March 5, 2026
Hazard Level
HIGH
Brand
Cook
Category
Health & Personal Care
Sold At
Multiple Retailers
At-Risk Groups
GENERAL, PREGNANT, PETS

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cook Incorporated or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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About This Product

Arterial pressure monitoring trays are used in healthcare settings to collect arterial blood samples or monitor pressure during procedures. They are part of critical diagnostic and treatment workflows.

Why This Is Dangerous

The hazard is labeling that misstates shelf life, which could affect device integrity or usage timing.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Immediate action required for clinical settings. No injuries reported in the notice; potential risks exist if expired labeling leads to improper use.

Practical Guidance

How to identify if yours is affected

  1. Verify Reference Part Numbers APMY-2.5-15-0-2.5 and APMY-4.0-21J-1-12.
  2. Match Lot Numbers 15894185X and 15264260X.
  3. Check expiration labeling against lot paperwork.

Where to find product info

FDA recall page Z-1778-2026 and Cook Medical recall communications.

What timeline to expect

Remedies will be provided by Cook Medical; processing times vary. Expect several weeks for replacement or refund.

If the manufacturer is unresponsive

  • Document all attempts to contact Cook Medical.
  • Escalate to hospital risk management or patient safety officers.

How to prevent similar issues

  • Carefully verify expiration labels on all medical device lots.
  • Implement batch-level verification during receiving and inventory.
  • Train staff to report mislabeled lots quickly.

Documentation advice

Keep recall notices, correspondence, lot numbers, and supplier communications in a dedicated file.

Product Details

Product: Arterial Pressure Monitoring Tray. Reference Part Numbers: APMY-2.5-15-0-2.5 (Lot 15894185X) and APMY-4.0-21J-1-12 (Lot 15264260X). UDI and lot numbers listed in recall notice. Quantity: 20 units. Distribution: Worldwide. Recall date: 2026-03-05.

Reported Incidents

No injuries or incidents are described in the provided notice.

Key Facts

  • 20 units recalled
  • Two reference part numbers: APMY-2.5-15-0-2.5 and APMY-4.0-21J-1-12
  • Lot numbers 15894185X and 15264260X
  • Expiration dates mislabeled beyond shelf life
  • Worldwide distribution
  • Active recall as of 2026-04-15

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPETS
Injury Types
OTHER

Product Classification

Product Details

Brand
Model Numbers
Reference Part Number APMY-2.5-15-0-2.5
UDI (01)00827002584129(17)270212(10)15894185X
Lot Number 15894185X
UDI (01)00827002584129(17)261108(10)15747314X
Lot Number 15747314X
+3 more
Report Date
April 15, 2026
Recall Status
ACTIVE

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