Wilson Cook Medical recalls
Wilson Cook Medical appears in 24 official U.S. recall notices indexed by RecallRadar, most recently on 2026-09-23.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 24 |
|---|---|
| Published | 2019-02-06 to 2026-09-23 |
| By agency | FDA Device (24) |
| By classification | Class II (24) |
| By status | ongoing (17), terminated (7) |
| Distribution named in notices | CA, CO, IN, NC, US |
Recalls
- Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEM…
FDA Device · Class II · 2026-09-23 · Wilson Cook Medical
Reason: Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU). - Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
FDA Device · Class II · 2026-04-22 · Wilson Cook Medical
Reason: Due to increased in complaints their is the potential for endoscopic clipping device to malfunction. - Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number:…
FDA Device · Class II · 2026-02-25 · Wilson Cook Medical
Reason: Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting. - Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10
FDA Device · Class II · 2026-02-11 · Wilson Cook Medical
Reason: Nasal feeding tube packaged without the nasal transfer tube component. - Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile
FDA Device · Class II · 2024-12-11 · Wilson Cook Medical
Reason: Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated. - Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile
FDA Device · Class II · 2024-10-23 · Wilson Cook Medical
Reason: Specific lots of product have been manufactured with nonconforming raw materials. - QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667
FDA Device · Class II · 2023-12-13 · Wilson Cook Medical
Reason: Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding… - QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654
FDA Device · Class II · 2023-12-13 · Wilson Cook Medical
Reason: Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding… - QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765
FDA Device · Class II · 2023-12-13 · Wilson Cook Medical
Reason: Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding… - QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766
FDA Device · Class II · 2023-12-13 · Wilson Cook Medical
Reason: Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding… - QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656
FDA Device · Class II · 2023-12-13 · Wilson Cook Medical
Reason: Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding… - QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657
FDA Device · Class II · 2023-12-13 · Wilson Cook Medical
Reason: Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding… - QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655
FDA Device · Class II · 2023-12-13 · Wilson Cook Medical
Reason: Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding… - Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278
FDA Device · Class II · 2023-08-09 · Wilson Cook Medical
Reason: Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical lithotripsy). - Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277
FDA Device · Class II · 2023-08-09 · Wilson Cook Medical
Reason: Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical lithotripsy). - Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572
FDA Device · Class II · 2023-06-28 · Wilson Cook Medical
Reason: There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endosc… - Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049
FDA Device · Class II · 2023-06-28 · Wilson Cook Medical
Reason: There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endosc… - HEMO-7 Hemospray Endoscopic Hemostat
FDA Device · Class II · 2020-04-29 · Wilson Cook Medical
Reason: Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Most of these co… - HEMO-10 Hemospray Endoscopic Hemostat
FDA Device · Class II · 2020-04-29 · Wilson Cook Medical
Reason: Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Most of these co… - Hemospray Endoscopic Hemostat
FDA Device · Class II · 2019-09-25 · Wilson Cook Medical
Reason: Potential for Hemospray device to be unable to spray powder due to misassembly of devices. - Acuject Variable Injection Needle
FDA Device · Class II · 2019-08-07 · Wilson Cook Medical
Reason: Potential for occluded injection needles. - Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy
FDA Device · Class II · 2019-04-24 · Wilson Cook Medical
Reason: Complaints of the snare loop not completely retracting and/or misshaping of the snare loop. - COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S
FDA Device · Class II · 2019-02-06 · Wilson Cook Medical
Reason: The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) were mislabeled as Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) and Captura Serrated Large Forcep-No Spike… - COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S
FDA Device · Class II · 2019-02-06 · Wilson Cook Medical
Reason: The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) were mislabeled as Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) and Captura Serrated Large Forcep-No Spike…