Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported May 20, 2026
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.
Due to nonconforming products being inadvertently distributed.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Stryker Corporation recalled Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The Fluid… - a moderate-severity action.
Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The Fluid… was recalled by Stryker Corporation in May 20, 2026. Reason: Due to nonconforming products being inadvertently distributed.. Check the official notice for the remedy. Verify recall #Z-2166-2026 with the FDA Devices before acting.
The recall
Stryker Corporation issued this moderate-severity FDA Devices recall-Due to nonconforming products being inadvertently distributed..
- Moderate
- severity level
- Class II
- classification
- May 20, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2166-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2166-2026) was formally reported on May 20, 2026, with the manufacturer initiating the action on April 9, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Stryker Corporation is listed as the recalling firm, operating out of San Jose, CA. Federal records list the affected scope as 10 tube sets.
The documented reason for this recall is: Due to nonconforming products being inadvertently distributed. Distribution data in the federal record shows the product reached: U.S. Nationwide distribution in the state of GA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
10 tube sets
Related Recalls
6
3 from same agency
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.
Reason for recall
Due to nonconforming products being inadvertently distributed.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2166-2026 |
| Date reported | May 20, 2026 |
| Date initiated | April 9, 2026 |
| Recalling firm | Stryker Corporation |
| Firm location | San Jose, CA |
| Affected scope | 10 tube sets |
| Distribution | U.S. Nationwide distribution in the state of GA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2166-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Stryker Corporation. Units affected: 10 tube sets.
Why was this product recalled? ▼
Due to nonconforming products being inadvertently distributed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 20, 2026. Severity: Moderate. Recall number: Z-2166-2026.
Where was the recalled product distributed? ▼
Distribution: U.S. Nationwide distribution in the state of GA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2166-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 20, 2026. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.