Recall Z-2166-2026 ยท HIG Insufflator, Hysteroscopic
Stryker Corporation
Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.
| Date | May 12, 2026 (initiated Apr 9, 2026) |
| Status | Open, Classified |
| Reason | Due to nonconforming products being inadvertently distributed. |
| Root cause | Process change control |
| Action | On 04/09/2026, the firm sent via USPS Certified Mail an "URGENT: MEDICAL DEVICE RECALL" Letter to customers that Stryker identified that certain lots of FluidSmart tube sets were manufactured with an incorrect pressure relief valve specification. This defect may prevent the pressure relief valve from activating at the intended pressure in the event of a capital device over pressure failure. One lot (Lot B000576601, quantity 10) impacted by this nonconformance was inadvertently shipped to a customer. Customers are instructed to: 1. Inform individuals within their organization who need to be aw |
| Quantity | 10 tube sets |
| Distribution | U.S. Nationwide distribution in the state of GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172048 | FluidSmart Thermedx, LLC, Sep 5, 2017 |