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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98630

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
April 06, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Stryker Neurovascular

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

INZONE DETACHMENT SYSTEM, REF: M00345100950

Z-2552-2026
Recall number
Z-2552-2026
Initiated
April 06, 2026
Classification
Class II
Status
Ongoing
Recalling firm
Stryker Neurovascular
Quantity
44,937

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

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.