Stryker recalls disposable suction/irrigator units with disposable tips due to potential irrigation solution leaking into handpiece and battery pack, causing malfunction.
“Stryker Disposable Suction/Irrigator Recall: Irrigation Solution Leak Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52014-stryker-disposable-suction-irrigator-recall-irrigation-solution-leak-risk. Based on FDA recall #Z-2171-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2171-2025%22&limit=1).
The FDA announced on June 18, 2025, that Stryker Corporation is recalling the StrykeFlow REF: 0250070520 / 2 Disposable Suction/Irrigator with Disposable Tip due to a potential leak of irrigation solution into the handpiece and battery pack. This defect may cause the device to malfunction.
How to tell if you have it
Brand: Stryker
Product: StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
UDI: 07613327061369
The hazard
According to the FDA, complaints indicate that irrigation solution may leak into the handpiece and battery pack, causing it to malfunction.
Context
GovInfoNow's records show Stryker Corporation has 34 other recalls on record since November 17, 2017. Recent Stryker recalls include an AHTO Tube Set leaking during use on June 8, 2026, and a Neptune Smart Docking Station electrical shock risk on May 6, 2026. Other recent recalls of similar products include Medline medical procedure kits with Strykeflow 2 irrigation leak risk (December 16, 2025) and Medline Medical Kits Recall: Suction Irrigator Leaks Saline Vapor (December 16, 2025).
How to tell if you have this one
Check for the Stryker brand with model reference 0250070520 / 2 on the product. The unique device identifier (UDI) is 07613327061369.
Brand
Stryker
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Argentina, Philippines, Singapore, China, Japan, Canada, Korea.
Verify the product model number and unique device identifier (UDI) to confirm if it's recalled.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 50 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2171-2025 (June 18, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2171-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.