Recall of COOK MEDICAL Wayne Pneumothorax Tray Due to Incorrect Expiration Dates

Source: FDA · Worldwide

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Cook Incorporated is recalling 318 units of the COOK MEDICAL Wayne Pneumothorax Tray because they were labeled with expiration dates that exceed the true shelf life, affecting worldwide distribution.

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

This notice was issued by FDA on April 23, 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 of COOK MEDICAL Wayne Pneumothorax Tray

What Happened

Cook Incorporated initiated a voluntary recall of certain medical devices due to products being labeled with expiration dates that exceed their true shelf life. This issue was identified in the affected lots, potentially affecting the usability of the devices.

Which Products Are Affected

The affected products are the COOK MEDICAL Wayne Pneumothorax Tray with Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH and Order Number G56537. Specific codes include: UDI (01)00827002565371(17)261020(10)15719344X for Lot Number 15719344X; UDI (01)00827002565371(17)261018(10)15714808X for Lot Number 15714808X; UDI (01)00827002565371(17)260115(10)15834145 for Lot Number 15834145; and UDI (01)00827002565371(17)260115(10)15834147 for Lot Number 15834147. A total of 318 units are affected, with worldwide distribution.

What You Should Do

Consumers and users should follow the initial firm notification, which was made through methods such as email, fax, letter, press release, telephone, or visit, to obtain instructions from Cook Incorporated regarding the recall.

Why This Matters

This recall highlights potential risks associated with mislabeled medical devices, which could lead to the use of expired products and affect patient safety. It involves 318 units distributed worldwide, emphasizing the importance of accurate labeling in the medical device industry.

Source

This information is attributed to the FDA recall database. For more details, refer to the FDA's official recall notice under recall number Z-1792-2026.

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 recalling 318 units of the COOK MEDICAL Wayne Pneumothorax Tray because they were labeled with expiration dates that exceed the true shelf life, 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.