Ambitex NMD400 Nitrile Exam Gloves size medium — Class II medical device recall Z-0133-2016
Terminated recall by Cardinal Health, reported 2015-10-28, distributed nationwide. Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. The produ
| Recall number | Z-0133-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health, Waukegan, IL, United States |
| Recall initiated | 2015-08-25 |
| Classified | 2015-10-16 |
| Reported by FDA | 2015-10-28 |
| Terminated | 2016-08-01 |
| Distributed | Nationwide (US) |
| Quantity | 34 cases |
| Reason classes | packaging |
| Lot numbers | 25314 |
Product
Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Reason for recall
Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. The product was under Exam Hold because samples pulled from a shipment manufactured by the firm failed the water leak test performed by FDA as described at 21 CFR 800.20.
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-0133-2016. 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.