Recall of COOK MEDICAL Wayne Pneumothorax Set 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 voluntarily recalling 104 units of the COOK MEDICAL Wayne Pneumothorax Set because the products were labeled with expiration dates that exceed their 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 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 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.
What Happened
Cook Incorporated is recalling certain lots of the COOK MEDICAL Wayne Pneumothorax Set due to the products being labeled with expiration dates that exceed the true shelf life.
Which Products Are Affected
The affected products are:
- Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532
- Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535 Quantity: 104 units Lot Numbers: 15719344X, 15714808X, 15834145, 15834147 UDI codes: (01)00827002565371(17)261020(10)15719344X, (01)00827002565371(17)261018(10)15714808X, (01)00827002565371(17)260115(10)15834145, (01)00827002565371(17)260115(10)15834147 Distribution: Worldwide Official Recall Number: Z-1791-2026
What You Should Do
Consumers should check if they have the affected products and contact Cook Incorporated for instructions, as the firm initiated notifications through methods such as email, fax, letter, press release, telephone, or visit.
Why This Matters
This recall involves medical devices with incorrect expiration dates, which could lead to potential safety issues if used beyond their actual shelf life; it underscores the need for accurate labeling in healthcare products.
Source
FDA Recall Number: Z-1791-2026
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
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 (1,233 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 22, 2026.
Frequently Asked Questions
Common questions about this FDA recall.