Synchro2 — Class II medical device recall Z-0227-2020
Terminated recall by Stryker Neurovascular, reported 2019-11-06, distributed nationwide.
| Recall number | Z-0227-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Neurovascular, Fremont, CA, United States |
| Recall initiated | 2018-06-08 |
| Classified | 2019-10-29 |
| Reported by FDA | 2019-11-06 |
| Terminated | 2021-04-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EG, ES, FI, FR, GB, HK, HR, HU, ID, IL, IN, IR, IT, JO, JP, KR, LT, MX, NL, NO, PH, PL, PT, RO, RU, SA, SE, SG, SK, TH, TR, ZA |
| Quantity | 831 |
| UPC / GTIN / UDI-DI | 04546540688743 |
| Model numbers | 2631 |
Product
Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
Reason for recall
Not stated by FDA.
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-0227-2020. 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.