Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be
FDA device recall Z-2166-2026 · posted 2026-05-12 · Open, Classified
Recall details
- Recalling firm
- Stryker Corporation
- Reason for recall
- Due to nonconforming products being inadvertently distributed.
- Action taken
- 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 aware of this action. 2. Check internal inventory to locate the product listed in the product affected grid. 3. If affected product is found, stop use immediately, segregate the product and call Stryker Customer Service at 1-800-624-4422 (Option 3) or email endocustomersupport@stryker.com to arrange for product return and issuance of credit or replacement (upon availability). a. Remove the affected products, quarantine, and discontinue use of the identified product. b. Please complete Business Reply Form on Attachment A on Page 2 and return it to EndoRecall@stryker.com. 4. If affected product is NOT found: a. Please complete Business Reply Form on Attachment A on Page 2 and return it to EndoRecall@stryker.com. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. Response is required. For questions - EndoRecall@stryker.com or 1-800-624-4422 (Option 3).
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- HIG
- Quantity affected
- 10 tube sets
- Distribution
- U.S. Nationwide distribution in the state of GA.
- Date initiated
- 2026-04-09
- Date posted
- 2026-05-12
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FluidSmart (K172048) | Thermedx, LLC | 2017-09-05 |