FDA Device recall Z-0916-2022
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
- 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 Extra Support by Boston Scientific, citing pouch seals may be open, compromising sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0916-2022 |
| 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 Extra Support
Reason
Pouch seals may be open, compromising sterility.
Identifiers
| code_info | ROTAWIRE Drive Extra Support, 5 pack, UPN: H74939463005 Individual units within 5-pack are labeled as Single, UPN: H749…ROTAWIRE Drive Extra Support, 5 pack, UPN: H74939463005 Individual units within 5-pack are labeled as Single, UPN: H74939463001 Batch numbers: 27630467, 27632712, 27701910, 27705926, 27749752, 27749754, 27792970 27804244, 27805109, 27806091, 27826574, 27826576, 27853736, 27853738, and 27862767 GTIN: 08714729996231 |
|---|
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-0916-2022%22
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