Has Stryker Corporation had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 94 total FDA actions tied to Stryker Corporation, including 94 recalls and 0 warning letters.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

FDA Recall Database: Class II Recall: Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI… by Stryker Corporation

Stryker Corporation 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 (additional items listed in FDA's full record) on 2026-05-20. FDA classified this action as a Class II recall (recall number Z-2166-2026). Reason for recall: Due to nonconforming products being inadvertently distributed.. Recall status: Ongoing. This is a device-category FDA recall record.

Key facts

Recalling firm	Stryker Corporation
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
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.
Classification	Class II
Recall number	Z-2166-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	Due to nonconforming products being inadvertently distributed.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Stryker Corporation and the affected product is described in FDA's record as: 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 (additional items listed in FDA's full record). FDA's stated reason for the recall is: Due to nonconforming products being inadvertently distributed.. The recall is tracked under FDA recall number Z-2166-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- 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 (additional items listed in FDA's full record) -- and the recall number Z-2166-2026. If it matches, stop using or distributing it and contact Stryker Corporation or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

Stryker Corporation’s FDA history

Argus HQ has recorded 94 total FDA actions tied to Stryker Corporation: 0 warning letters, 94 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Has Stryker Corporation had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 94 total FDA actions tied to Stryker Corporation, including 94 recalls and 0 warning letters.
What is the FDA recall number for this event?: FDA recall number Z-2166-2026.
What is the current status of this recall?: Status as recorded by FDA: Ongoing.
Where can I verify this recall directly with FDA?: The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

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Full FDA history for Stryker Corporation

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Recall Database: Class II Recall: Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI… by Stryker Corporation. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/fda-recall-stryker-corporation-z-2166-2026

MLA

"FDA Recall Database: Class II Recall: Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI… by Stryker Corporation." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/fda-recall-stryker-corporation-z-2166-2026.

Chicago

Argus HQ Research. "FDA Recall Database: Class II Recall: Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI… by Stryker Corporation." Digital Empire Holdings LLC. Accessed August 29, 2026. https://argushq.ai/recall/fda-recall-stryker-corporation-z-2166-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_stryker_corporation_z_2166_2026_2026,
  title = {FDA Recall Database: Class II Recall: Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI… by Stryker Corporation},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/recall/fda-recall-stryker-corporation-z-2166-2026},
  note = {Accessed: August 29, 2026}
}

Source: FDA.gov — Recalls ↗