CLASS II ONGOING Device recall · Reported 30 Jul 2025 · FDA Enforcement Report

Stryker, StrykeFlow , REF: 0250070500, 2, Disposable recalled

Stryker is recalling Stryker, StrykeFlow , REF: 0250070500, 2, Disposable, distributed nationwide in the US. The recall was initiated on 18 Jun 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 07613327061390

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2170-2025
FDA event ID: 97039
Recalling firm: Stryker, San Jose, CA
Classification: Class II
Status: Ongoing
Recall initiated: 18 Jun 2025
FDA classified: 23 Jul 2025
Reported: 30 Jul 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

18 Jun 2025	Recall initiated by company
23 Jul 2025	Classified by FDA	+35 days
30 Jul 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.

Which lots are affected?

UDI: 07613327061390

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 97039

This product is part of a recall event; the main page for the event is Stryker, StrykeFlow REF: 0250070520 recalled.

Reported	Class	Recall	Company	Reason	Where
30 Jul 2025	CLASS II	Stryker, StrykeFlow REF: 0250070520 recalled	Stryker	Packaging Defects	Nationwide

More recalls from Stryker

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Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Device	CLASS II	Pkg., Strykeflow Suction/irrigator Ps recalled by Stryker	Stryker	Packaging Defects	Nationwide
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