Recall of Sterile Powdered Surgical Gloves Due to Banned Powder Content
WRP Asia Pacific Sdn Bhd is recalling 201,000 pairs of AmerisourceBergen sterile surgical gloves because some left-handed gloves contain powder, which is banned in the U.S.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly lists severe health consequences including 'severe airway inflammation' and 'granuloma and adhesion formation,' which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk medical device defects, warranting a score of 4.
Plain-English summary
WRP Asia Pacific Sdn Bhd is recalling 201,000 pairs of AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112. The recall is limited to Lot 705366565. The affected gloves were distributed to distributors in Alabama, California, Ohio, Idaho, Kansas, Minnesota, North Carolina, Pennsylvania, and Texas.
The recall was initiated because some left-handed gloves in the lot contain powder. Powdered surgical gloves are classified as a banned medical device in the United States. The presence of powder on natural rubber latex gloves can aerosolize latex allergens, leading to sensitization and allergic reactions. Additional risks associated with powdered gloves include severe airway inflammation, conjunctivitis, dyspnea, and the formation of granulomas and adhesions when exposed to internal tissue.
Healthcare facilities and distributors should stop using the affected gloves and contact the recalling firm for instructions on return or disposal. Consumers who have purchased these specific gloves should discontinue use and contact the manufacturer or their healthcare provider for guidance.
The recalled product
- Product
- AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
- Manufacturer
- WRP Asia Pacific Sdn Bhd
- Category
- Medical Device — Surgical Gloves
- Affected units
- 201,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 705366565
Distribution
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