Recall of Cook Medical NCompass Nitinol Stone Extractor for Expiration Date Issue

Source: FDA · Worldwide

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Cook Incorporated is voluntarily recalling 70 units of the COOK MEDICAL NCompass Nitinol Stone Extractor due to incorrect expiration dates on the labels.

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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What Happened

Cook Incorporated is recalling certain lots of the COOK MEDICAL NCompass™ Nitinol Stone Extractor because the products were labeled with expiration dates that exceed the true shelf life.

Which Products Are Affected

The affected products include:

  • Reference Part Number: C-NTSE-2.4-115-NC3, Order Number: G36250, with UDI (01)00827002362505(17)261103(10)15741134 and Lot Number: 15741134
  • Reference Part Number: C-NTSE-2.4-115-NCT4, Order Number: G36251, with UDI (01)00827002362512(17)270118(10)15855141 and Lot Number: 15855141 A total of 70 units are affected, with worldwide distribution.

What You Should Do

Consumers who have the affected products should contact Cook Incorporated, as the recall was initiated through methods such as email, fax, letter, press release, telephone, or visit, for further instructions.

Why This Matters

This recall addresses potential risks from using medical devices with incorrect expiration dates, which could affect their safety and effectiveness.

Source

FDA Recall Number: Z-1787-2026

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Cook Incorporated is voluntarily recalling 70 units of the COOK MEDICAL NCompass Nitinol Stone Extractor due to incorrect expiration dates on the labels.
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.