Class II — WRP Asia Pacific Sdn Bhd
| Recalling firm | WRP ASIA PACIFIC SDN. BHD. |
|---|---|
| Registered facility | WRP ASIA PACIFIC SDN. BHD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112 |
| Quantity | 201,000 pairs |
| Distribution | Distributors in AL, CA, OH, ID, KS, MN, NC, PA, TX. |
| Initiated | 2018-05-07 |
| Classified | 2018-05-30 |
| Terminated | 2019-05-30 |
| Recall number | Z-2036-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — WRP Asia Pacific Sdn Bhd (Z-2036-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79992/
Alerts for WRP ASIA PACIFIC SDN. BHD.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.