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Thermedx FluidSmart Urology Tube Set REF LL0006 recallZ-2166-2026 · Stryker Corporation · initiated Apr 9, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to nonconforming products being inadvertently distributed.

FDA root cause category: Process change control

What the company is doing

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).

Recall details

Recall number
Z-2166-2026
Status
Open, Classified
Initiated by the company
Apr 9, 2026
Posted by the FDA
May 12, 2026
Recalling firm
Stryker Corporation
Quantity
10 tube sets
Product code
HIG
FDA submissions
K172048
Distribution
U.S. Nationwide distribution in the state of GA.

Product description

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.

Code information (models, lots, serial numbers)

Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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