INZONE DETACHMENT SYSTEM — Class II medical device recall Z-2552-2026
Ongoing recall by Stryker Neurovascular, reported 2026-07-01, distributed nationwide. Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not
| Recall number | Z-2552-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Neurovascular, Fremont, CA, United States |
| Recall initiated | 2026-04-06 |
| Classified | 2026-06-24 |
| Reported by FDA | 2026-07-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BE, BG, CA, CH, CL, CO, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IR, IS, JP, KR, LU, LV, MX, MY, NL, NO, PH, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, TH, TR, TW, ZA |
| Quantity | 44,937 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04546540697950 |
| Lot numbers | 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 and 13 more |
| Model numbers | M00345100950 |
Product
INZONE DETACHMENT SYSTEM, REF: M00345100950
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2552-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.