Wilson-cook Medical Inc.
FDA adverse event reports naming Wilson-cook Medical Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: WILSON-COOK MEDICAL INC..
- Total reports
- 1,330
- Deaths
- 8
- Injuries
- 162
- Malfunctions
- 1,156
Reports per year
Source: FDA adverse event reports by year received, 2011–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Ligator, EsophagealMND384
- Unit, Electrosurgical, Endoscopic (With Or Without Accessories)KNS360
- Dilator, EsophagealKNQ239
- Ligator, HemorrhoidalFHN53
- Tubes, Gastrointestinal (And Accessories)KNT50
- Forceps, Biopsy, Non-ElectricFCL42
- Product code KOGKOG41
- Stents, Drains And Dilators For The Biliary DuctsFGE23
- Endoscopic Guidewire, Gastroenterology-UrologyOCY20
- Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast InjectionGCA16
Recent recalls
- 2026-04-13Open, ClassifiedProcess control
Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
- 2026-02-13Open, ClassifiedUnder Investigation by firm
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 cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.
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.
- 2026-02-05Open, ClassifiedEmployee error
Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10
Nasal feeding tube packaged without the nasal transfer tube component.
- 2024-12-02Open, ClassifiedNonconforming Material/Component
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
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.
- 2024-10-16Open, ClassifiedNonconforming Material/Component
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 bleeding.
Specific lots of product have been manufactured with nonconforming raw materials.
- 2023-12-01Open, ClassifiedUnder Investigation by firm
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
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.
- 2023-12-01Open, ClassifiedUnder Investigation by firm
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree
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.
- 2023-12-01Open, ClassifiedUnder Investigation by firm
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
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.
- 2023-12-01Open, ClassifiedUnder Investigation by firm
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree
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.
- 2023-12-01Open, ClassifiedUnder Investigation by firm
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures of the biliary tree
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.
Monitor Wilson-cook Medical Inc. automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.