MEDLINE SIRUS Surgical Gown — Class II medical device recall Z-3079-2017
Ongoing recall by Master & Frank (Pinghu) Co., Ltd., reported 2017-09-06, distributed in IL. The sleeve seam of the breathable material was found to have inconsistent sealing, which has the potential to
| Recall number | Z-3079-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Master & Frank (Pinghu) Co., Ltd., Hangzhou, N/A, China |
| Recall initiated | 2017-06-01 |
| Classified | 2017-08-28 |
| Reported by FDA | 2017-09-06 |
| Distributed | IL |
| Quantity | 2,160 units |
| Serial numbers | 45016070513PH |
Product
MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile Gown/Hand Towel/CSR Wrap and boxes of 18 Gowns.
Reason for recall
The sleeve seam of the breathable material was found to have inconsistent sealing, which has the potential to allow fluid to flow pass through the protective seam.
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-3079-2017. 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.