Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 — Class II medical device recall Z-0711-2024
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-01-17, distributed in MD, OH, TN, TX, WI. Surgical gowns were manufactured with the wrong sleeve.
| Recall number | Z-0711-2024 |
|---|---|
| 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 | 2023-11-29 |
| Classified | 2024-01-11 |
| Reported by FDA | 2024-01-17 |
| Distributed | MD, OH, TN, TX, WI |
| Quantity | 2,100 gowns |
| UPC / GTIN / UDI-DI | 40080196029755 |
| Lot numbers | 11023060120 |
| Model numbers | 100/PACK, PT-2208CS |
Product
Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
Reason for recall
Surgical gowns were manufactured with the wrong sleeve.
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-0711-2024. 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.