Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall - 713,702 Units

Class 2 Device Recall Instinct Plus Endoscopic Clipping Device

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| | Class 2 Device Recall Instinct Plus Endoscopic Clipping Device | |

REF: G58010
Rx Only, Sterile EO |
| Code Information | All Lots manufactured between 9/2/2023-04/20/2025 ; UDI: (01)10827002580104 |
| FEI Number | 1037905 |
| Recalling Firm/
Manufacturer | Wilson-Cook Medical Inc.
4900 Bethania Station Rd
Winston Salem NC 27105-1203 |
| For Additional Information Contact | Cook Medical Customer Relations
800-4574500 |
| Manufacturer Reason
for Recall | Due to increased in complaints their is the potential for endoscopic clipping device to malfunction. |
| FDA Determined
Cause | Process control |
| Action | On March 2, 2026, Cook Medical, issued a "Urgent: Medical Device Recall" Notification to affected consignees via: Fed Ex. Cook Medical asked consignees to take the following actions:

1. Examine inventory immediately to determine if you have affected devices. Immediately cease use of the affected devices and quarantine all affected devices.
2. Return the affected devices to Cook Medical.
3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter.
4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred.
5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com.
6. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm. Call the FDA at 800.FDA.1088. | | Quantity in Commerce | 713,702 units | | 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, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, Brunei, Darussalam, Brazil, Canada, CANARY ISLANDS, Chile, China, Colombia, Costa Rica, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, Egypt, FINLAND, FRANCE, GERMANY, GREECE, Guatemala, Hong Kong, HUNGARY, Indonesia, India, IRELAND, ISRAEL, ITALIA, KUWAIT, LEBANON, LUXEMBOURG, MALTA, MAYOTTE, Mexico, Macao, MOROCCO, Malaysia, NEDERLAND, NORWAY, New Zealand, OMAN, PAKISTAN, Peru, POLAND, PORTUGAL, QATAR, REUNION, ROMANIA, SAUDI ARABIA, SLOVENIA, El Salvador, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, Thailand, TURKEY, Taiwan, United Arab Emirates, United Kingdom. | | Total Product Life Cycle | TPLC Device Report |

| 1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes. | |

| 510(K) Database | 510(K)s with Product Code = PKL |