Stryker Corporation recalls Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The Flu…

Due to nonconforming products being inadvertently distributed.

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).

• FDA enforcement recordOfficial FDA database entry for Z-2166-2026
• FDA 510(k) clearance · K172048The device's official FDA premarket clearance record
• FDA device classification · HIGOfficial FDA classification for this device type
• CFR regulation · 21 CFR 884.1700The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Stryker CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.