FDA Recall of Instinct Plus Endoscopic Clipping Device

Source: FDA · United States and Worldwide

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Wilson-Cook Medical Inc. is voluntarily recalling 713,702 units of the Instinct Plus Endoscopic Clipping Device due to potential malfunction from increased complaints.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 3, 2026 and geographically references United States and 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

Wilson-Cook Medical Inc. is initiating a voluntary recall of the Instinct Plus Endoscopic Clipping Device because of increased complaints indicating a potential for the device to malfunction.

Which Products Are Affected

The affected product is the Instinct Plus Endoscopic Clipping Device, REF: G58010, Rx Only, Sterile EO. A total of 713,702 units are involved, specifically all lots manufactured between September 2, 2023, and April 20, 2025. The UDI is (01)10827002580104. Distribution occurred nationwide in the United States, including all states, and worldwide to various countries.

What You Should Do

Consumers and users should follow the initial firm notification, which was issued via letter, and contact Wilson-Cook Medical Inc. at their address: 4900 Bethania Station Rd, Winston Salem, NC 27105-1203, for further instructions regarding the recall.

Why This Matters

This recall affects a large quantity of medical devices used in procedures, potentially impacting patient safety due to the risk of malfunction.

Source

Attribution: FDA. For more information, refer to the FDA recall details under recall number Z-1812-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Wilson-Cook Medical Inc. is voluntarily recalling 713,702 units of the Instinct Plus Endoscopic Clipping Device due to potential malfunction from increased complaints.
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 United States and 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.