FDA Device recall Z-0763-2022
HYDRATOME RX 49-20MM/260CM Material Number: M00583000
- FDA Device
- Class II
- ongoing
- Published 2022-03-23
On 2022-03-23 the FDA classified a Class II recall of HYDRATOME RX 49-20MM/260CM Material Number: M00583000 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-0763-2022 |
| 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
HYDRATOME RX 49-20MM/260CM Material Number: M00583000
Reason
Sterility of device is compromised due to a sterile barrier breach
Identifiers
| code_info | Lot Numbers: 27852433 28028722 GTIN: 8714729755159 |
|---|
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-0763-2022%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.