Stryker Corporation: Electrosurgical, Cutting & Coagulation & Accessories

Stryker Corporation is recalling a Single Spike Tube Set used with electrosurgical equipment (catalog number 0250070530) because the handpiece has been leaking during use. The product was distributed worldwide, including across all US states and multiple countries. This is a Class II recall, meaning the product may cause adverse health effects but is not expected to cause serious injury.

Recalling firm
Stryker Corporation
Product
STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
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/5c2d59a0-84ef-417c-be20-7cae046c2b69