FDA Medical devices recall ·
STRYKER PKG., SINGLE SPIKE TUBE SET recall
- Recall number
- Z-2865-2026
- Date
- (initiated June 8, 2026)
- Company / brand
- Stryker Corporation
5900 Optical Ct, San Jose, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 11,857 Units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
Why was it recalled?
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
GTIN 07613327061352, Batch Numbers 24260FG2, 24261FG2, 24297FG2, 24298FG2, 24299FG2, 24302FG2, 24340FG2, 24341FG2, 25008FG2, 25009FG2, 25010FG2, 25011FG2, 25024FG2, 25034FG2, 25035FG2, 25052FG2, 25063FG2, 25064FG2, 25084FG2, 25092FG2, 25093FG2, 25121FG2, 25134FG2, 25135FG2, 25153FG2, 25154FG2, 25167FG2, 25182FG2, 25183FG2, 25216FG2, 25217FG2, 25245FG2, 25274FG2.
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2865-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.