Z-2170-2025Class II

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

Name: Z-2170-2025 Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
Creator: Stryker Corporation
Published: 2025-06-18
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2025-06-18 / Open, Classified

FDA source

Stryker Corporation began a recall of Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip on 2025-06-18. FDA classified it as Class II and gives the reason as "Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2170-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-18
Posted: 2025-07-23
Recalling firm: Stryker Corp.
Product: Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
Product code: GCJ Laparoscope, General & Plastic Surgery
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.
FDA root cause: Under Investigation by firm
Action: On June 18, 2025, Stryker issued a "Urgent: Medical Device Recall" Notification to affected consignees. On November 20, 2025, Stryker initiated a recall notification update. Stryker ask consignees to take the following actions: 1. Inform individuals within your organization who need to be aware of this action. 2. Check your internal inventory to locate the affected product. 3. If affected product is found, quarantine and initiate the return process for affected units. 3a. Please complete Business Reply Form or use QR Code on Attachment A to return product. 4. If affected product is NOT found: 4a. 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. Response is required.
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.
Product codes and lots: UDI: 07613327061390

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2170-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2170-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-23
Z-2171-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-23

Product code GCJ

K934094Class IIStryker Laparoscopic Suction IrrigatorStryker Corp. / cleared 1994-02-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)