Stay Safe Cap — Class II medical device recall Z-0507-2024
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2023-12-13, distributed nationwide. Updating the labeling to include additional warnings and contraindications for potential side effects.
| Recall number | Z-0507-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2023-10-10 |
| Classified | 2023-12-07 |
| Reported by FDA | 2023-12-13 |
| Distributed | Nationwide (US) |
| Quantity | 18,236,160 eaches |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00840861100835 |
| Model numbers | 050-95012 |
Product
Stay Safe Cap
Reason for recall
Updating the labeling to include additional warnings and contraindications for potential side effects.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0507-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.