FDAClass II · Medical device · Recall Z-2552-2026 · Recalled July 1, 2026
INZONE DETACHMENT SYSTEM recall — Stryker Neurovascular
Agency report date: July 1, 2026.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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.
Agency product description and boundaries
INZONE DETACHMENT SYSTEM, REF: M00345100950
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
2. Agency hazard and consumer action
FDA reports: 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.
No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.
Class II: may cause temporary or medically reversible health consequences.
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.
Firm notified the public via
N/A
FDA event ID
98630
Recall initiated
April 6, 2026
FDA classified
June 24, 2026
FDA report date
July 1, 2026
Related recalls
Other medical device recalls from around the same time
Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes;
the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved September 29, 2026 at 6:00 PM UTC.