Z-2866-2026 Class II Ongoing

Recalled by Stryker Corporation — San Jose, CA

FDA device recall Z-2866-2026 was initiated by Stryker Corporation on June 8, 2026 and is designated Class II. Reason for recall: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. The recall status is ongoing. Affected quantity: 589 Units.

Recall Details

Product Type
Devices
Report Date
August 12, 2026
Initiation Date
June 8, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
589 Units

Product Description

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

Reason for Recall

There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

Distribution Pattern

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.

Code Information

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