FDA Medical Device Recalls (openFDA)
O&M HALYARD INC: HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
- Recall number
- Z-0317-2022
- Recalling firm
- O&M HALYARD INC
- Product
- HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
- Status
- Open, Classified
- Initiated
- 2021-09-27
- Posted
- not on file
- Terminated
- not on file
- Reason
- All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.
- Root cause
- Component design/selection
- Action
- O&M Halyard Inc has issued a voluntary recall of the Sterling Zero Nitrile Powder-free Exam Glove on 10/08/2021 by email or Fed Ex. The letter requested that the consignee segregate and destroy all affected product. Distributors were directed to notify their customers.
- Quantity
- 2,928 cases (5,856,000 gloves)
- Distribution
- Worldwide distribution - US Nationwide and the countries of EU/Canada.
- Lot, serial or model codes
- All lots of the following sizes: a. XS, REF 47459, UDI (01)20680651474593 b. S, REF 47460, UDI (01)20680651474609 c. M, REF 47461, UDI (01)20680651474616 d. L, REF 47462, UDI (01)20680651474623 e. XL, REF 47463, UDI (01)20680651474630
- 510(k) numbers
- ["K182851"]
- PMA numbers
- not on file
- Product code
- LZC
- Firm FEI
- 3014421917
- Firm city
- Alpharetta
- 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