Data Foundry

Medical device recalls 2016

Sterling Nitrile Sterile Powder Free Exam Gloves — Class II medical device recall Z-0758-2017

Terminated recall by Halyard Health, reported 2016-12-21, distributed in CA, FL, GA, IA, IN, LA, MA, MN…. Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves withou

Recall numberZ-0758-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmHalyard Health, Roswell, GA, United States
Recall initiated2016-11-10
Classified2016-12-14
Reported by FDA2016-12-21
Terminated2017-05-04
DistributedCA, FL, GA, IA, IN, LA, MA, MN, MT, NM, OR, TX, UT
Quantity59 cases
Lot numbersSM52721, SM52741

Product

Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.

Reason for recall

Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing.

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-0758-2017. 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.