Breast Augmentation Pack — Class II medical device recall Z-0155-2017
Terminated recall by Windstone Medical Packaging, Inc., reported 2016-10-26, distributed nationwide. The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because
| Recall number | Z-0155-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Windstone Medical Packaging, Inc., Billings, MT, United States |
| Recall initiated | 2015-04-22 |
| Classified | 2016-10-20 |
| Reported by FDA | 2016-10-26 |
| Terminated | 2016-10-25 |
| Distributed | Nationwide (US) |
| Quantity | 1,498 kits |
| Reason classes | sterility |
| Lot numbers | 57138, 57192, 58407, 59278, 60740, 61619, 62067, 62436, 62922, 63467, 63539, 64110, 64703, 65271, 65364, 65837, 65894, 67400, 67704, 68310, 68624, 69434, 69850, 70246, 70351, 71639, 71656, 71948, 71949, 72862, 72944, 73628, 73680, 73982, 73989, 74027, 74377, 74582, 74974, 75175 and 14 more |
| Model numbers | AMS1786 |
Product
Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430. convenience custom kits used for general surgery in hospital operating room
Reason for recall
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
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-0155-2017. 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.