Z-2166-2026Class II

Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are...

Name: Z-2166-2026 Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are...
Creator: Stryker Corporation
Published: 2026-04-09
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2026-04-09 / Open, Classified

FDA source

Stryker Corporation began a recall of Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid... on 2026-04-09. FDA classified it as Class II and gives the reason as "Due to nonconforming products being inadvertently distributed". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2166-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-09
Posted: 2026-05-12
Recalling firm: Stryker Corp.
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.
Product code: HIG Insufflator, Hysteroscopic
Reason for recall: Due to nonconforming products being inadvertently distributed.
FDA 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 [email protected] 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 [email protected]. 4. If affected product is NOT found: a. Please complete Business Reply Form on Attachment A on Page 2 and return it to [email protected]. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. Response is required. For questions - [email protected] or 1-800-624-4422 (Option 3).
Quantity in commerce: 10 tube sets
Distribution: U.S. Nationwide distribution in the state of GA.
Product codes and lots: Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2166-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2166-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-12

Product code HIG

K172048Class IIFluidSmartThermedx, LLC / cleared 2017-09-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)