FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2166-2026
- Recalling firm
- Stryker Corporation
- Product
- 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.
- Status
- Open, Classified
- Initiated
- 2026-04-09
- Posted
- 2026-05-12
- Terminated
- not on file
- 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 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).
- Quantity
- 10 tube sets
- Distribution
- U.S. Nationwide distribution in the state of GA.
- Lot, serial or model codes
- Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601
- 510(k) numbers
- K172048
- PMA numbers
- not on file
- Product code
- HIG
- Firm FEI
- 2936485
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28