FDA Device recall Z-1491-2022
EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components
- FDA Device
- Class II
- ongoing
- Published 2022-08-10
On 2022-08-10 the FDA classified a Class II recall of EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components by Boston Scientific, citing product may be mislabeled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1491-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-05-25 |
| Published | 2022-08-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | CA, CT, GA, IA, IL, IN, NY, OH, TX, WY |
Product
EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.
Reason
Product may be mislabeled.
Identifiers
| code_info | UPN: 500-56112 GTIN: 858593006264 Lot Numbers: 8035075263, 8035075264, 8035075265, 8035075266, 8035075267, 803507…UPN: 500-56112 GTIN: 858593006264 Lot Numbers: 8035075263, 8035075264, 8035075265, 8035075266, 8035075267, 8035075268, 8035075269, 8035075270, 8035075271, 8035075272 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1491-2022%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.