Stryker Thermedx FluidSmart Urology Tube Set Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Stryker Corporation is recalling 10 units of Thermedx FluidSmart Urology Tube Set (REF LL0006, Lot B000576601) due to nonconforming products being inadvertently distributed.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 2, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Stryker Corporation initiated a voluntary recall of the Thermedx FluidSmart Urology Tube Set because nonconforming products were inadvertently distributed.
Which Products Are Affected
Thermedx FluidSmart Urology Tube Set REF LL0006 (UDI-DI: 00860936000365), Catalog Number LL0006, Lot Number B000576601. A total of 10 tube sets were distributed nationwide in the United States, including the state of GA.
What You Should Do
Consumers should follow instructions provided by the recalling firm regarding the affected products.
Why This Matters
The recall involves a Class II medical device used in laparoscopic and endoscopic procedures for irrigation and fluid management.
Source
FDA recall number Z-2166-2026, event ID 98696. Recalling firm: Stryker Corporation, San Jose, CA.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (809 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 2, 2026.
Frequently Asked Questions
Common questions about this FDA recall.