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U.S. Department of Health and Human Services

Class 2 Device Recall Thermedx FluidSmart Urology Tube Set

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 Class 2 Device Recall Thermedx FluidSmart Urology Tube Setsee related information
Date Initiated by FirmApril 09, 2026
Date PostedMay 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2166-2026
Recall Event ID 98696
510(K)NumberK172048 
Product Classification Insufflator, hysteroscopic - Product Code HIG
ProductThermedx 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 Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601
FEI Number 2936485
Recalling Firm/
Manufacturer		 Stryker Corporation
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information ContactMelanie Shepard
408-754-2000
Manufacturer Reason
for Recall		Due to nonconforming products being inadvertently distributed.
FDA Determined
Cause 2		Process change control
ActionOn 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 endocustomersupport@stryker.com 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 EndoRecall@stryker.com. 4. If affected product is NOT found: a. Please complete Business Reply Form on Attachment A on Page 2 and return it to EndoRecall@stryker.com. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. Response is required. For questions - EndoRecall@stryker.com or 1-800-624-4422 (Option 3).
Quantity in Commerce10 tube sets
DistributionU.S. Nationwide distribution in the state of GA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HIG
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