Wilson-Cook Medical Inc.

Complete recall history across all FDA and CPSC categories — 22 total recalls

Wilson-Cook Medical Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (22)

FDA medical device enforcement actions by Wilson-Cook Medical Inc.

Date Product Reason Class
Mar 3, 2026 Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO Due to increased in complaints their is the potential for endoscopic clippin... Class II
Dec 18, 2025 Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784... Due to product that may contain a void in the material that separates the wir... Class II
Dec 15, 2025 Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10 Nasal feeding tube packaged without the nasal transfer tube component. Class II
Oct 31, 2024 Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, ste... Specific lots of product have been manufactured with nonconforming raw materi... Class II
Aug 29, 2024 Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Steril... Specific lots of product have been manufactured with nonconforming raw materi... Class II
Nov 3, 2023 QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; use... Nonconforming devices while manufactured correctly, do not comply to their de... Class II
Nov 3, 2023 QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; us... Nonconforming devices while manufactured correctly, do not comply to their de... Class II
Nov 3, 2023 QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used ... Nonconforming devices while manufactured correctly, do not comply to their de... Class II
Nov 3, 2023 QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used... Nonconforming devices while manufactured correctly, do not comply to their de... Class II
Nov 3, 2023 QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; use... Nonconforming devices while manufactured correctly, do not comply to their de... Class II
Nov 3, 2023 QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used ... Nonconforming devices while manufactured correctly, do not comply to their de... Class II
Nov 3, 2023 QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used ... Nonconforming devices while manufactured correctly, do not comply to their de... Class II
Jun 22, 2023 Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion... Non-conforming product may appear in the field as inability to advance or ret... Class II
Jun 22, 2023 Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion ... Non-conforming product may appear in the field as inability to advance or ret... Class II
May 22, 2023 Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G5657... There are potential risks of the Hemospray powder adhering to the distal end ... Class II
May 22, 2023 Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G210... There are potential risks of the Hemospray powder adhering to the distal end ... Class II
Feb 4, 2020 HEMO-10 Hemospray Endoscopic Hemostat Complaints that the handle and/or activation knob on Hemostat devices have cr... Class II
Feb 4, 2020 HEMO-7 Hemospray Endoscopic Hemostat Complaints that the handle and/or activation knob on Hemostat devices have cr... Class II
Jul 24, 2019 Hemospray Endoscopic Hemostat Potential for Hemospray device to be unable to spray powder due to misassembl... Class II
Jun 14, 2019 Acuject Variable Injection Needle Potential for occluded injection needles. Class II
Jan 4, 2019 Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical... Complaints of the snare loop not completely retracting and/or misshaping of t... Class II
Dec 18, 2018 COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4S... The product is being recalled because Captura Serrated Forceps with Spike (DB... Class II
Dec 18, 2018 COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with ... The product is being recalled because Captura Serrated Forceps with Spike (DB... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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