RUMMELL — Class II medical device recall Z-0760-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-01-01, distributed nationwide. Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to incr
| Recall number | Z-0760-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-11-12 |
| Classified | 2024-12-23 |
| Reported by FDA | 2025-01-01 |
| Distributed | Nationwide (US) |
| Quantity | 21,440 total |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00653160251227, 10653160251224 |
| Lot numbers | 2023111490 |
| Model numbers | ST006ST |
Product
RUMMELL, Medline Item No. ST006ST
Reason for recall
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
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-0760-2025. 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.