AmerisourceBergen PF Latex SG — Class II medical device recall Z-2036-2018
Terminated recall by WRP Asia Pacific Sdn Bhd, reported 2018-06-06, distributed in AL, CA, ID, KS, MN, NC, OH, PA…. Some left-handed gloves contain powder. Powdered surgical gloves are a banned medical device in the U.S. Powde
| Recall number | Z-2036-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | WRP Asia Pacific Sdn Bhd, Sepang, N/A, Malaysia |
| Recall initiated | 2018-05-07 |
| Classified | 2018-05-30 |
| Reported by FDA | 2018-06-06 |
| Terminated | 2019-05-30 |
| Distributed | AL, CA, ID, KS, MN, NC, OH, PA, TX |
| Quantity | 201,000 pairs |
| Reason classes | undeclared allergen |
| Lot numbers | 705366565 |
| Model numbers | 10112 |
Product
AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
Reason for recall
Some left-handed gloves contain powder. Powdered surgical gloves are a banned medical device in the U.S. Powder on natural rubber latex gloves can aerosolize latex allergens, resulting in sensitization to latex and allergic reactions. Additional risks of powdered gloves include severe airway inflammation, conjunctivitis, dyspnea, as well as granuloma and adhesion formation when exposed to internal tissue.
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-2036-2018. 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.