Recall Record: Class II Recall: Instinct Plus Endoscopic Clipping Device REF: G58010 Rx… by Wilson-Cook Medical Inc.

Key facts

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO -- and the recall number Z-1812-2026. If it matches, stop using or distributing it and contact Wilson-Cook Medical Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Wilson-Cook Medical Inc. and the affected product is described in FDA's record as: Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO. FDA's stated reason for the recall is: Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.. The recall is tracked under FDA recall number Z-1812-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

Wilson-Cook Medical Inc.’s FDA history

Argus HQ has recorded 1 total FDA action tied to Wilson-Cook Medical Inc.: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What was recalled and why?

Wilson-Cook Medical Inc. recalled Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO. FDA's record states the reason for recall as: Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.. The recall is logged under FDA recall number Z-1812-2026 with a Class II classification.

How serious is this recall?

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO) and recall number Z-1812-2026, then follow Wilson-Cook Medical Inc.'s recall instructions.

Has Wilson-Cook Medical Inc. had other FDA recalls or enforcement actions?

This is the only FDA action Argus HQ has on file for Wilson-Cook Medical Inc. so far. Argus ingests new FDA enforcement records daily.

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