FDA Device recall Z-0711-2024
Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile
- FDA Device
- Class II
- ongoing
- Published 2024-01-17
On 2024-01-17 the FDA classified a Class II recall of Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile by Medline Industries Northfield, citing surgical gowns were manufactured with the wrong sleeve.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0711-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-29 |
| Published | 2024-01-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | MD, OH, TN, TX, WI |
Product
Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
Reason
Surgical gowns were manufactured with the wrong sleeve.
Identifiers
| code_info | Lot #11023060120, UDI (01)40080196029755(11)230615(10)11023060120. |
|---|
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-0711-2024%22
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