FDA Device recall Z-0227-2020
Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO - Product Usage: produc…
- FDA Device
- Class II
- terminated
- Published 2019-11-06
On 2019-11-06 the FDA classified a Class II recall of Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO - Product Usage: produc… by Stryker Neurovascular.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0227-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-08 |
| Published | 2019-11-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Stryker Neurovascular |
| Distribution | US |
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
Identifiers
| code_info | UPN: M00326310 Lot Numbers/UDI: 0000000563/ (01)04546540688743(17)201031(10)0000000563; 0000000986/ (01)0454654068…UPN: M00326310 Lot Numbers/UDI: 0000000563/ (01)04546540688743(17)201031(10)0000000563; 0000000986/ (01)04546540688743(17)201031(10)0000000986; 0000001646/ (01)04546540688743(17)201130(10)0000001646; 0000002238/ (01)04546540688743(17)201130(10)0000002238; 0000002426/ (01)04546540688743(17)201231(10)0000002426; 0000002640/ (01)04546540688743(17)201231(10)0000002640; 0000003465/ (01)04546540688743(17)210131(10)0000003465; 0000004906/ (01)04546540688743(17)210228(10)0000004906; 0000005147/ (01)04546540688743(17)210228(10)0000005147; 0000005343/ (01)04546540688743(17)210228(10)0000005343; 0000007637/ (01)04546540688743(17)210421(10)0000007637; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0227-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.