Z-0835-2018Class II

StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR...

Name: Z-0835-2018 StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR...
Creator: Stryker Corporation
Published: 2017-11-17
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2017-11-17 / Terminated / root cause: sterility

FDA source

Stryker Corporation began a recall of StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER... on 2017-11-17. FDA classified it as Class II and gives the reason as "Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0835-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-17
Posted: 2018-03-02
Terminated: 2024-01-29
Recalling firm: Stryker Corp.
Product: StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); c. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Strykeflow 2 with Tip (Model 0250070520) STRYKER LAPAROSCOPIC SUCTION IRRIGATOR
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: On about 11/17/2017 letters were sent by certified mail with tracking information to all domestic accounts and International Stryker sites were notified by email. Instructions include to inform individuals who need to be aware of the device recall, examine all stock areas and/or operating room storage for affected product quarantine and discontinue use of the recalled devices, complete the acknowledgement form, and if affected product is found contact Stryker customer service at 1-800-624-4422 (Option 3) or email [email protected] to arrange for product return.
Quantity in commerce: 60,753 units total
Distribution: Distributed domestically to . Distributed internationally to Australia and Mexico.
Product codes and lots: a. Model 0250070500, Product Code GCJ, UDI 07613327061390, Lot No. 17275FG2, 17276FG2, 17277FG2, 17278FG2, 17279FG2, 17280FG2, 17283FG2, 17284FG2, 17285FG2, 17286FG2, 17289FG2, 17290FG2, 17291FG2, 17292FG2, 17293FG2, 17294FG2, 17297FG2, 17299FG2, 17301FG2); 0250070505, 0250070520; b. Model 0250070505, Product Code GCX, UDI 07613327061406, Lot No. 17294FG2; c. Model 0250070520, Product Code GCX, UDI 07613327061369, Lot No. 17282FG2, 17283FG2, 17286FG2, 17289FG2, 17290FG2, 17292FG2, 17293FG2, 17294FG2, 17296FG2, 17297FG2, 17298FG2, 17299FG2, 17300FG2, 17301FG2, 17302FG2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0835-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0835-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-02
Z-0836-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-02
Z-0837-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-02
Z-0838-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-02

Product code GCJ

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)