Wilson-Cook Medical Inc.
FDA Regulatory Profile
Wilson-Cook Medical Inc. appears in FDA public data with 23 recalls, 126 510(k) clearances, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1812-2026, Class II) was initiated on March 3, 2026. Its most recent 510(k) clearance was granted on June 2, 2026.
Summary
- Total Recalls
- 23
- 510(k) Clearances
- 126
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1812-2026 | Class II | Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO | March 3, 2026 |
| Z-1362-2026 | Class II | Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002 | December 18, 2025 |
| Z-1298-2026 | Class II | Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10 | December 15, 2025 |
| Z-0582-2025 | Class II | Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile. | October 31, 2024 |
| Z-0036-2025 | Class II | Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospra | August 29, 2024 |
| Z-0463-2024 | Class II | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures | November 3, 2023 |
| Z-0458-2024 | Class II | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures | November 3, 2023 |
| Z-0459-2024 | Class II | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of | November 3, 2023 |
| Z-0457-2024 | Class II | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures o | November 3, 2023 |
| Z-0461-2024 | Class II | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures | November 3, 2023 |
| Z-0460-2024 | Class II | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of | November 3, 2023 |
| Z-0462-2024 | Class II | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of | November 3, 2023 |
| Z-2252-2023 | Class II | Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction | June 22, 2023 |
| Z-2253-2023 | Class II | Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction | June 22, 2023 |
| Z-1978-2023 | Class II | Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G2 | May 22, 2023 |
| Z-1979-2023 | Class II | Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF | May 22, 2023 |
| Z-1746-2020 | Class II | HEMO-10 Hemospray Endoscopic Hemostat | February 4, 2020 |
| Z-1745-2020 | Class II | HEMO-7 Hemospray Endoscopic Hemostat | February 4, 2020 |
| Z-2541-2019 | Class II | Hemospray Endoscopic Hemostat | July 24, 2019 |
| Z-2089-2019 | Class II | Acuject Variable Injection Needle | June 14, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253302 | Hemospray Endoscopic Hemostat (HEMO-[X]) | June 2, 2026 |
| K251104 | SureTome SW Sphincterotome with DomeTip | September 29, 2025 |
| K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | January 17, 2025 |
| K213356 | Entuit PEG, Entuit PEGJ | January 20, 2022 |
| K212323 | Instinct Plus Endoscopic Clipping Device | August 25, 2021 |
| K201322 | Entuit Nasal Jejunal Feeding Tube | June 17, 2020 |
| K200972 | Hemospray Endoscopic Hemostat | June 10, 2020 |
| K200247 | Fusion Quattro Extraction Balloon | February 27, 2020 |
| K192339 | TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord | January 30, 2020 |
| K193344 | Tri-Ex Extraction Balloon with Multiple Sizing | December 13, 2019 |
| K192908 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes | November 14, 2019 |
| K191048 | AcuSnare Polypectomy Snare - Duckbill | July 18, 2019 |
| K183336 | Entuit PEG, Entuit PEGJ | May 29, 2019 |
| K181317 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush | February 8, 2019 |
| K182319 | Glo-Tip Spray Catheter | February 1, 2019 |
| K182895 | Wilson-Cook Achalasia Balloon | January 25, 2019 |
| K182381 | Wilson-Cook Mini Basket | October 30, 2018 |
| K173673 | AcuSnare Polypectomy Snare | August 24, 2018 |
| K173659 | Howell D.A.S.H Extraction Balloon with Multiple Sizing | July 6, 2018 |
| DEN170015 | Hemospray Endoscopic Hemostat | May 7, 2018 |