FDA Device recall Z-0753-2022
DREAMTOME 44-30MM/260CM Material Number: M00584050
- FDA Device
- Class II
- ongoing
- Published 2022-03-23
On 2022-03-23 the FDA classified a Class II recall of DREAMTOME 44-30MM/260CM Material Number: M00584050 by Boston Scientific, citing sterility of device is compromised due to a sterile barrier breach.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0753-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-12-22 |
| Published | 2022-03-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
DREAMTOME 44-30MM/260CM Material Number: M00584050
Reason
Sterility of device is compromised due to a sterile barrier breach
Identifiers
| code_info | Lot Numbers: 27453804 27457431 27549729 27556712 27575367 27579180 27605386 27605881 27660096 27667092 27672343 2770819…Lot Numbers: 27453804 27457431 27549729 27556712 27575367 27579180 27605386 27605881 27660096 27667092 27672343 27708191 27709633 27787771 27789167 27899695 27924755 27971482 27976277 27979230 28047306 28054381 GTIN: 8714729778271 |
|---|
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-0753-2022%22
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