Recall Z-2166-2026

Reason for recall

Due to nonconforming products being inadvertently distributed.

FDA-determined cause: Process change control

Action taken

On 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).