Z-2552-2026Class II

Inzone Detachment System, Ref: M00345100950

Name: Z-2552-2026 Inzone Detachment System, Ref: M00345100950
Creator: Stryker Neurovascular
Published: 2026-04-06
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2026-04-06 / Open, Classified / root cause: design

FDA source

Stryker Neurovascular began a recall of INZONE DETACHMENT SYSTEM, REF: M00345100950 on 2026-04-06. FDA classified it as Class II and gives the reason as "Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2552-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-06
Posted: 2026-06-24
Recalling firm: Stryker Corp.
Product: Inzone Detachment System, Ref: M00345100950
Product code: HCG Device, Neurovascular Embolization
Reason for recall: Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.
Root cause tag: design
FDA root cause: Component design/selection
Action: On 4/3/2026, recall notices were mailed to Supply Chain Management and Recall Coordinators who were asked to do the following: 1) Segregate the affected devices in a secure location for return to recalling firm. 2) If any of the subject devices have been distributed to other organizations, please forward a copy of this notice to the new users and provide contact details to recalling firm so new recipients can be informed appropriately. 3) Maintain awareness of this communication internally until all required actions have been completed within your facility. 4) Complete and return the Business Reply Form via email to [email protected] For any additional information or questions, please contact [email protected] or US Customer Service: 1-855-91-NEURO (1-855-916-3876), Email: [email protected]
Quantity in commerce: 44,937
Distribution: Worldwide - US Nationwide distribution including in the states of PA, AZ, FL, CA, IL, AK, NY, MI, NJ, WI, SD, KY, AR, TX, AL, TN, MO, MA, IN, NE, WV, MT, CT, NC, VA, NV, CO, DC, DE, OH, ME, GA, WA, SC, GU, MN, OK, NH, MD, ND, UT, HI, OR, LA, MS, KS, NM, ID, IA, VT and the countries of ARGENTINA, AUSTRIA, BELGIUM, BRASIL, BULGARIA, CANADA, CANARY ISLANDS, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, IRAN, IRELAND, ISRAEL, ITALIA, JAPAN, KOREA, LATVIA, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NORTHERN IRELAND, NORWAY, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH PACIFIC, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM.
Product codes and lots: UDI-DI: 04546540697950. Lots: WMP133638, WMP133871, WMP133872, WMP133988, WMP133989, WMP134016, WMP134132, WMP134133, WMP134234, WMP134235, WMP134255, WMP134256, WMP134380, WMP134381, WMP134432, WMP134433, WMP134518, WMP134519, WMP134609, WMP134610, WMP134794, WMP134795, WMP134939, WMP134940, WMP135187, WMP135243, WMP135302, WMP135314, WMP135354, WMP135355, WMP135387, WMP135417, WMP135473, WMP135475, WMP135491, WMP135492, WMP135623, WMP135720, WMP135727, WMP135807, WMP135865, WMP135897, WMP136084, WMP136107, WMP136190, WMP136200, WMP136611, WMP136642, WMP136736, WMP136748, WMP136852, WMP136894, WMP136985

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2552-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2552-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-24

Product code HCG

K212455Class IIInZone Detachment SystemStryker Neurovascular / cleared 2021-11-16

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)