Recall Z-2866-2026 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Stryker Corporation
STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540
| Date | Aug 3, 2026 (initiated Jun 8, 2026) |
| Status | Open, Classified |
| Reason | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. |
| Root cause | Under Investigation by firm |
| Action | Stryker issued an URGENT: Medical Device Recall notice to its consignees on 7/6/2026 via USPS Certified Mail. The notice explained the issue, potential risks, and requested the following: "Actions needed: 1. Inform individuals within your organization who need to be aware of this action. 2. Check your internal inventory to locate the affected product using Attachment B. 3. If affected product is found a. Quarantine, stop use and initiate the return process for affected units. b. Please complete Business Reply Form or use QR Code on Attachment A. 4. If affected product is NOT |
| Quantity | 589 Units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963646 | STRYKER STRYKEFLOW SUCTION IRRIGATOR GRAVITY FLOW Stryker Endoscopy, Apr 16, 1997 |