FDA Device recall Z-2036-2018
AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
- FDA Device
- Class II
- terminated
- Published 2018-06-06
On 2018-06-06 the FDA classified a Class II recall of AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112 by Wrp Asia Pacific Sdn Bhd, citing 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, resu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2036-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-07 |
| Published | 2018-06-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Wrp Asia Pacific Sdn Bhd |
| Distribution | AL, CA, ID, KS, MN, NC, OH, PA, TX |
Product
AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
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.
Identifiers
| code_info | Lot 705366565 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2036-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.