FDA Medical Device Recalls (openFDA)
Halyard Health: Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.
- Recall number
- Z-0758-2017
- Recalling firm
- Halyard Health
- Product
- Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.
- Status
- Terminated
- Initiated
- 2016-11-10
- Posted
- 2016-12-14
- Terminated
- 2017-05-04
- Reason
- Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing.
- Root cause
- Under Investigation by firm
- Action
- Consignees were notified by letter via Fed Ex on/about 11/10/2016.
- Quantity
- 59 cases
- Distribution
- CA, FL, GA, IA, IN, LA, MA, MN, MT, NM, OR, TX and UT.
- Lot, serial or model codes
- Product Code: 53130 01 (105313001), Lot numbers: SM52741 and SM52721.
- 510(k) numbers
- ["K081027"]
- PMA numbers
- not on file
- Product code
- LZA
- Firm FEI
- 3011157493
- Firm city
- Roswell
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28