FDA Device recall Z-0507-2024
Stay Safe Cap
- FDA Device
- Class II
- ongoing
- Published 2023-12-13
On 2023-12-13 the FDA classified a Class II recall of Stay Safe Cap by Fresenius Medical Care Holdings, citing updating the labeling to include additional warnings and contraindications for potential side effects.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0507-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-10 |
| Published | 2023-12-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
Product
Stay Safe Cap
Reason
Updating the labeling to include additional warnings and contraindications for potential side effects.
Identifiers
| code_info | Model No. 050-95012; UDI-DI: 00840861100835; All Lots. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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FDA Drug · Class II · 2026-05-13 · Fresenius Medical Care Holdings
All Fresenius Medical Care Holdings recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0507-2024%22
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