BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Recall
- Recall Number
- Z-2183-2026
- Event Number
- 98708
- Firm
- Stryker Sustainability Solutions
- FEI Number
- 3009350690
- Product Code
- NLH
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- April 10, 2026
- Posted
- May 13, 2026
- Address
- 1810 W Drake Dr, Tempe, AZ, 85283-4327
Description
BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
Stryker issued a Medical Device Recall notice to its consignees on 4/10/2026 via USPS certified mail. The notice explained the product issue, potential risk, and requested the following: "Customer Actions Requested: Our records indicate that you may have distributed, received and/or used the above affected products. 1. Inform individuals within your organization who need to be aware of this action. 2. Check your internal inventory to locate the affected product. Segregate the affected products, quarantine and discontinue use. 3. Please complete the Business Reply Form and return the completed via email to [email protected], or use the QR Code on Attachment B. Response is required. a. If you have indicated that product remains in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to your facility for products returned upon receipt. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility." "For any additional information or questions please reach out to [email protected] or Stryker Customer Service at 800-624-4422."
US Nationwide and the countries of Israel and Canada.
154 units