Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to
Summary
The FDA issued a Class II for Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 by Stryker Corporation. Reason: Due to nonconforming products being inadvertently distributed..
Details
Source
Device Recall
External ID
Z-2166-2026
Action Date
2026-05-20
Status
Ongoing
Category
device
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.
Lot/Code Info: Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601
Quantity Affected: 10 tube sets
Reason for Recall
Due to nonconforming products being inadvertently distributed.
Distribution
U.S. Nationwide distribution in the state of GA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-09
Company
San Jose, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 243 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker Corporation has 98 FDA actions in our database, including 90 recalls and 8 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Corporation have FDA actions?
Stryker Corporation has 98 FDA actions in our database, including 90 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2166-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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