Stryker Corporation: Electrosurgical, Cutting & Coagulation & Accessories

Recall Summary Stryker Corporation is recalling the StrykeFlow Suction/Irrigator PS handpiece (Catalog Number 0250070540) because it has been leaking fluid during use. The product was distributed worldwide, including throughout the United States and multiple other countries. This is a Class II recall, meaning the product may cause adverse health consequences or serious injury.

Recalling firm
Stryker Corporation
Product
STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540
Reason
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-06-08
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/3c9646da-7f52-4ade-b70b-7e94a1f773ed