FDA Recall of Cook Medical Arterial Pressure Monitoring Tray Due to Incorrect Expiration Dates

Source: FDA · Worldwide

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Cook Incorporated is voluntarily recalling 20 units of specific Arterial Pressure Monitoring Trays because of incorrect expiration dates on the labels, affecting worldwide distribution.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 22, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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Recall Article

What Happened

Cook Incorporated is recalling the products because they were labeled with expiration dates that exceed the true shelf life.

Which Products Are Affected

The affected products are COOK MEDICAL Arterial Pressure Monitoring Tray with the following details:

  • 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 Quantity: 20 units Lot numbers: 15894185X, 15747314X, 15264260X UDIs: (01)00827002584129(17)270212(10)15894185X for APMY-2.5-15-0-2.5; (01)00827002584129(17)261108(10)15747314X for APMY-2.5-15-0-2.5; (01)00827002584198(17)260202(10)15264260X for APMY-4.0-21J-1-12 Distribution: Worldwide Official recall number: Z-1778-2026

What You Should Do

Consumers should follow the initial firm notification methods, which include email, fax, letter, press release, telephone, or visit, to get instructions from Cook Incorporated.

Why This Matters

This recall involves medical devices with incorrect expiration dates, which could affect their reliability and potentially impact patient care.

Source

Attribution: FDA. For more information, visit the FDA website at https://www.fda.gov/safety/recalls/

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Cook Incorporated is voluntarily recalling 20 units of specific Arterial Pressure Monitoring Trays because of incorrect expiration dates on the labels, affecting worldwide distribution.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects Worldwide. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.