Recall of COOK MEDICAL Wayne Pneumothorax Set Due to Incorrect Expiration Dates
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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 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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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 ↗
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