FDA Device recall Z-0915-2022
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
- FDA Device
- Class II
- ongoing
- Published 2022-04-20
On 2022-04-20 the FDA classified a Class II recall of ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy by Boston Scientific, citing pouch seals may be open, compromising sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0915-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-08 |
| Published | 2022-04-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
Product
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
Reason
Pouch seals may be open, compromising sterility.
Identifiers
| code_info | ROTAWIRE Drive Floppy, 5 pack, UPN: H74939462005 Individual units within 5-pack are labeled as Single, UPN: H749394620…ROTAWIRE Drive Floppy, 5 pack, UPN: H74939462005 Individual units within 5-pack are labeled as Single, UPN: H74939462001 Batch numbers: 27622475, 27622478, 27691111, 27698472, 27706785, 27708190, 27756019 27756205, 27756933, and 27756935 GTIN: 08714729996255 |
|---|
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-0915-2022%22
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