Recall Z-1778-2026— Cook Incorporated

Name: FDA recall Z-1778-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-05

Class II · Ongoing

Class II FDA medical device recall by Cook Incorporated, initiated 2026-03-05. It names one FDA 510(k) clearance: K180846. Product: 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. Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life..

Recalling firm: Cook Incorporated
Classification: Class II
Status: Ongoing
Initiated: 2026-03-05
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K180846 — Arterial Pressure Monitoring Set/TrayCook Incorporated·cleared 2018-12-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.