Z-0317-2022Class II

HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL

Name: Z-0317-2022 HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
Creator: O&m Halyard Inc
Published: 2021-09-27
License: https://open.fda.gov/license/

O&M Halyard, Inc. / initiated 2021-09-27 / Open, Classified / root cause: design

FDA source

O&M HALYARD INC began a recall of HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL on 2021-09-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0317-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-27
Posted: 2021-12-01
Recalling firm: O&M Halyard, Inc.
Product: HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
Product code: LZC Medical Glove, Specialty
Reason for recall: 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 tag: design
FDA 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 in commerce: 2,928 cases (5,856,000 gloves)
Distribution: Worldwide distribution - US Nationwide and the countries of EU/Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0317-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0317-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-08	2021-12-01

Product code LZC

K182851Class ISkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsO&M Halyard, Inc. / cleared 2019-06-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)