FDA Device recall Z-1033-2022
TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only
- FDA Device
- Class II
- ongoing
- Published 2022-05-11
On 2022-05-11 the FDA classified a Class II recall of TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only by Johnson And Johnson Surgical Vision, citing potential breach in the sterility barrier for tray ring covers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1033-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-06 |
| Published | 2022-05-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Johnson And Johnson Surgical Vision |
| Distribution | US |
Product
TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
Reason
Potential breach in the sterility barrier for tray ring covers.
Identifiers
| code_info | All Lots within Expiry: GTIN:05050474520707 |
|---|
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-1033-2022%22
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