Recall StatusOpen, Classified
Date Initiated2025-01-29
Product Quantity9521 units
Reason for Recall
Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
Firm Action
On January 29, 2025, Stryker issued a "Urgent Medical Device Recall " notification to affected consignees via: certified mail. Stryker ask consignees to take the following actions:
Inform individuals within your organization who need to be aware of this device recall.
2. Check all stock areas and/or operating room storage to determine if any devices from the affected product list are at
your account. Response is required by January 30, 2026.
3. If affected product is found, quarantine and discontinue use of the recalled devices. Please complete the Business Reply
Form (page 3) of this notice and return devices back to Stryker Endoscopy.
a. Please call Customer Service at (800)624-4422 or email
[email protected] to arrange for
product return and issuance of credit or replacement (upon availability).
4. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so
Stryker can inform the recipients appropriately.
5. If no product is found, complete the acknowledgement form and return it back to Stryker via email to
[email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Argentina, Colombia, Netherlands, Spain, Mexico, Australia, United Kingdom, Brazil.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.