HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES… recallZ-0317-2022 · O&M Halyard Inc · initiated Sep 27, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from O&M Halyard Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Component design/selection
What the company is doing
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.
Recall details
- Recall number
- Z-0317-2022
- Status
- Open, Classified
- Initiated by the company
- Sep 27, 2021
- Recalling firm
- O&M Halyard Inc
- Quantity
- 2,928 cases (5,856,000 gloves)
- Product code
- LZC
- FDA submissions
- K182851
- Distribution
- Worldwide distribution - US Nationwide and the countries of EU/Canada.
Product description
HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
Code information (models, lots, serial numbers)
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
Devices named in this recall
5 devices in the FDA device registry whose identifier appears in the recall's code information.
- Halyard 47459O&M Halyard, Inc. · Polymer patient examination glove1 recall0 reports
- Halyard 47460O&M Halyard, Inc. · Polymer patient examination glove1 recall0 reports
- Halyard 47461O&M Halyard, Inc. · Polymer patient examination glove1 recall0 reports
- Halyard 47462O&M Halyard, Inc. · Polymer patient examination glove1 recall0 reports
- Halyard 47463O&M Halyard, Inc. · Polymer patient examination glove1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page