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

FDA device recall Z-2866-2026 · posted 2026-08-03 · Open, Classified

Recall details

Recalling firm

Stryker Corporation

Reason for recall

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

Action taken

Stryker issued an URGENT: Medical Device Recall notice to its consignees on 7/6/2026 via USPS Certified Mail. The notice explained the issue, potential risks, and requested the following: "Actions needed: 1. Inform individuals within your organization who need to be aware of this action. 2. Check your internal inventory to locate the affected product using Attachment B. 3. If affected product is found a. Quarantine, stop use and initiate the return process for affected units. b. Please complete Business Reply Form or use QR Code on Attachment A. 4. If affected product is NOT found: a. Please complete Business Reply Form or use QR Code on Attachment A. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility." For any additional information or questions please contact Endorecall@stryker.com or Stryker Customer Service at 800-624-4422.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GEI

Quantity affected

589 Units

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, Swed

Date initiated

2026-06-08

Date posted

2026-08-03

Location

San Jose, CA

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