Recall of COOK MEDICAL Wayne Pneumothorax Tray Due to Incorrect Expiration Dates
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, cpsc, Devices.
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 ↗
Related FDA Recalls
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Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,602 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 23, 2026.
Frequently Asked Questions
Common questions about this FDA recall.