StrykeFlow recallZ-2865-2026 · Stryker Corporation · initiated Jun 8, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
FDA root cause category: Under Investigation by firm
What the company is doing
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 [email protected] or Stryker Customer Service at 800-624-4422.
Recall details
- Recall number
- Z-2865-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 8, 2026
- Posted by the FDA
- Aug 3, 2026
- Recalling firm
- Stryker Corporation
- Quantity
- 11,857 Units
- Product code
- GEI
- FDA submissions
- K963646
- 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.
Product description
STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
Code information (models, lots, serial 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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- StrykeFlow 0250070530Stryker Corporation · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall12 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 99340).
- Z-2862-2026 · Open, ClassifiedSTRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
- Z-2863-2026 · Open, ClassifiedSTRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620
- Z-2864-2026 · Open, ClassifiedSTRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640
- Z-2866-2026 · Open, ClassifiedSTRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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