Recall Z-2865-2026— Stryker Corporation

Name: FDA recall Z-2865-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-08

Class II · Ongoing

Class II FDA medical device recall by Stryker Corporation, initiated 2026-06-08. It names one FDA 510(k) clearance: K963646. 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..

Recalling firm: Stryker Corporation
Classification: Class II
Status: Ongoing
Initiated: 2026-06-08
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K963646 — STRYKER STRYKEFLOW SUCTION IRRIGATOR GRAVITY FLOWStryker Endoscopy·cleared 1997-04-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.