FDA Device recall Z-0760-2025
RUMMELL, Medline Item No. ST006ST
- FDA Device
- Class II
- ongoing
- Published 2025-01-01
On 2025-01-01 the FDA classified a Class II recall of RUMMELL, Medline Item No. ST006ST by Medline Industries Northfield, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0760-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-12 |
| Published | 2025-01-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
RUMMELL, Medline Item No. ST006ST
Reason
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.
Identifiers
| code_info | UDI: 10653160251224 (ea) 00653160251227 (case); Lot 2023111490 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0760-2025%22
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