Z-2552-2026 Class II Ongoing
FDA device recall Z-2552-2026 was initiated by Stryker Neurovascular on April 6, 2026 and is designated Class II. 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 c… The recall status is ongoing. Affected quantity: 44,937.
Recall Details
- Product Type
- Devices
- Report Date
- July 1, 2026
- Initiation Date
- April 6, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44,937
Product Description
Reason for Recall
Distribution Pattern
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.