FDA Medical devices recall ·

STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS recall

Recall number
Z-2866-2026
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
589 Units
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540

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 0761332706146, Batch Numbers: 24297FG2, 24306FG2, 24344FG2, 25007FG2, 25065FG2, 25091FG2, 25168FG2.

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-2866-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.