STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540
Summary
The FDA issued a Class II for STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540 by Stryker Corporation. Reason: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use..
Details
Source
Device Recall
External ID
Z-2866-2026
Action Date
2026-08-12
Status
Ongoing
Category
device
Product Description
STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540
Lot/Code Info: GTIN 0761332706146, Batch Numbers: 24297FG2, 24306FG2, 24344FG2, 25007FG2, 25065FG2, 25091FG2, 25168FG2.
Quantity Affected: 589 Units
Reason for Recall
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-08
Company
San Jose, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 400 device-related FDA actions this month.
Stryker Corporation has 102 FDA actions in our database, including 95 recalls and 7 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Corporation have FDA actions?
Stryker Corporation has 102 FDA actions in our database, including 95 recalls and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2866-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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