WRP Asia Pacific Sdn Bhd: Medical Device Recall in 2018 - (Recall #: Z-2036-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112

Product Classification:

Class II

Date Initiated: May 7, 2018

Date Posted: June 6, 2018

Recall Number: Z-2036-2018

Event ID: 79992

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.

Status: Terminated

Product Quantity: 201,000 pairs

Code Information:

Lot 705366565

Distribution Pattern:

Distributors in AL, CA, OH, ID, KS, MN, NC, PA, TX.

Voluntary or Mandated:

Voluntary: Firm initiated