Winston Salem, NC, United States
Wilson-Cook Medical Inc. recalls
14 recalls recorded since 2018, most recently on 20 August 2026. 9 are listed as ongoing. Status and classification are as published by the FDA.
Recalls14
Ongoing (FDA)9
Terminated or completed5
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 20 August 2026
- Reason
- Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Argentina
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3177-2026
- Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Software Version: N/A Product Description: Hemostatic device for endo
Ongoing Class II Medical devices
- Recall started
- 3 March 2026
- Reason
- Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Argentina, AUS
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1812-2026
- Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Ongoing Class II Medical devices
- Recall started
- 18 December 2025
- 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.
- Distribution
- U.S. Distribution to states of: CA, CO, IN, and NC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1362-2026
- Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulat
Ongoing Class II Medical devices
- Recall started
- 15 December 2025
- Reason
- Nasal feeding tube packaged without the nasal transfer tube component.
- Distribution
- International distribution to the country of Australia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1298-2026
- Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10
Ongoing Class II Medical devices
- Recall started
- 31 October 2024
- 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.
- Distribution
- Distribution was OUS only to Argentina, Brazil, and Israel.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0582-2025
- Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
Ongoing Class II Medical devices
- Recall started
- 29 August 2024
- Reason
- Specific lots of product have been manufactured with nonconforming raw materials.
- Distribution
- Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Costa Rica, and Guatemala. UPDATE 1/30/2025: Foreign distribution was made to: Australia, Austria, Belgium, Canada, Chile, Costa Rica, Cyprus, Czech Republic, Denmark, Estonia,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0036-2025
- Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bl
Ongoing Class II Medical devices
- Recall started
- 3 November 2023
- 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 caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
- Distribution
- US
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0459-2024, Z-0460-2024, Z-0463-2024, Z-0457-2024, Z-0462-2024, Z-0458-2024, Z-0461-2024
- QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
- QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree
- QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree
- QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
- QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree
- QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree
- QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures of the biliary tree
Ongoing Class II Medical devices
- Recall started
- 22 June 2023
- 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).
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2253-2023, Z-2252-2023
- Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.
- Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.
Ongoing Class II Medical devices
- Recall started
- 22 May 2023
- 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 endoscope.
- Distribution
- US Nationwide - Worldwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1979-2023, Z-1978-2023
- Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
- Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;
Terminated Class II Medical devices
- Recall started
- 4 February 2020
- Terminated
- 15 January 2021
- 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 complaints reported that the carbon dioxide cartridge exited the handle with minimal force. However, some complaints reported that the carbon dioxide cartridge exited the handle with the potential to project towards a user or a patient.
- Distribution
- Nationwide distribution. International distribution to Bahrain, Belarus, Canary Islands, Gibraltar, Guadeloupe, Guernsey, Iraq, Israel, Jersey, Jordan, Kuwait, Lebanon, Martinique, Monaco, Morocco, Oman, Pakistan, Qatar, Reunion, Saudi Arabia, Tunisia, United Arab Emirates, Unites States, Canada, N
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1745-2020, Z-1746-2020
- HEMO-7 Hemospray Endoscopic Hemostat
- HEMO-10 Hemospray Endoscopic Hemostat
Terminated Class II Medical devices
- Recall started
- 24 July 2019
- Terminated
- 15 June 2020
- Reason
- Potential for Hemospray device to be unable to spray powder due to misassembly of devices.
- Distribution
- Nationwide distribution to CA, CO, CT, FL, IL, IN, KY, LA, MN, MO, NC, NJ, NY, OH, PA, RI, SD, TX, VA, WA. International distribution to Canada, Austria, Belgium, Cyprus, Denmark, France, Germany, Greece, Italy, Portugal, Spain, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2541-2019
- Hemospray Endoscopic Hemostat
Terminated Class II Medical devices
- Recall started
- 14 June 2019
- Terminated
- 2 April 2021
- Reason
- Potential for occluded injection needles.
- Distribution
- Distributed to China
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2089-2019
- Acuject Variable Injection Needle
Terminated Class II Medical devices
- Recall started
- 4 January 2019
- Terminated
- 21 July 2020
- Reason
- Complaints of the snare loop not completely retracting and/or misshaping of the snare loop.
- Distribution
- Worldwide Distribution: US (nationwide) in the states of: AL, AR, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and countries of: ARGENTINA, BRAZIL, CANADA, MEXICO, NETHERLANDS ANTILLES, AUSTR
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1132-2019
- Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.
Terminated Class II Medical devices
- Recall started
- 18 December 2018
- Terminated
- 14 December 2020
- 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 (DBF-2.4SL-230-20-S) were mislabeled as Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S).
- Distribution
- France, Ireland, Japan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0774-2019, Z-0775-2019
- COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S
- COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.