Recall of Cook Medical Cook Strange Bile Duct Stone Exploration Set

Source: FDA · Worldwide

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 49 units of a medical device due to incorrect expiration dates on the labels, which could affect product safety.

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, fda, Devices.

Recall of Cook Medical Device

What Happened

Cook Incorporated has initiated a voluntary recall of certain medical devices because the products were labeled with expiration dates that exceed their true shelf life. This issue was identified in specific lots of the device.

Which Products Are Affected

The affected product is the COOK MEDICAL Cook Strange Bile Duct Stone Exploration Set, with Reference Part Number C-CSRC-7.5D-40-STRANGE. The recall involves 49 units distributed worldwide. Specific codes include: Lot Number 15133690X with UDI (01)00827002091085(17)260221(10)15133690X; Lot Number 15274382 with UDI (01)00827002091085(17)260314(10)15274382; Lot Number 15435573 with UDI (01)00827002091085(17)270104(10)15435573; Lot Number 15445615 with UDI (01)00827002091085(17)270118(10)15445615; and Lot Number 15501690 with UDI (01)00827002091085(17)270104(10)15501690. The official recall number is Z-1784-2026.

What You Should Do

Consumers who have the affected products should follow the initial firm notifications, which may include email, fax, letter, press release, telephone, or visit from Cook Incorporated, for instructions on returns or further actions.

Why This Matters

This recall addresses potential safety concerns with medical devices that may not perform as intended due to incorrect expiration dates, emphasizing the importance of accurate labeling in healthcare products.

Source

This recall is attributed to the FDA, based on their records. For more information, refer to FDA resources.

Original source: FDA Official Notice ↗

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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.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Cook Incorporated is recalling 49 units of a medical device due to incorrect expiration dates on the labels, which could affect product safety.
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.