Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka — Class II medical device recall Z-0893-2017
Terminated recall by Ansell Healthcare Products LLC, reported 2016-12-28, distributed in FL, IL, MA, NJ, PA. Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive S
| Recall number | Z-0893-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ansell Healthcare Products LLC, Iselin, NJ, United States |
| Recall initiated | 2016-10-24 |
| Classified | 2016-12-22 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2017-10-23 |
| Distributed | FL, IL, MA, NJ, PA |
| Quantity | 15 cartons |
| Lot numbers | 1607018105 |
| Model numbers | 20277285 |
Product
Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium Manufactured for/ Fabrique' pour: Ansell Healthcare products LLC. 1635 Industrial Road Dothan, AL 36303, USA TEL USA- 1-800-952-9916 CAN- 1-844-494-7854 catalog #20277285
Reason for recall
Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive Surgical Gloves because the packaged contents incorrectly included a natural rubber Latex surgical glove.
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-0893-2017. 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.