Z-2230-2026Class II

Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.)...

Name: Z-2230-2026 Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.)...
Creator: O&m Halyard Inc
Published: 2026-04-13
License: https://open.fda.gov/license/

O&M Halyard, Inc. / initiated 2026-04-13 / Open, Classified

FDA source

O&M HALYARD INC began a recall of Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl) on 2026-04-13. FDA classified it as Class II and gives the reason as "Nitrile Exam Glove failed to meet specifications chemical permeation performance". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2230-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-13
Posted: 2026-05-22
Recalling firm: O&M Halyard, Inc.
Product: Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
Product code: LZC Medical Glove, Specialty
Reason for recall: Nitrile Exam Glove failed to meet specifications chemical permeation performance.
FDA root cause: Under Investigation by firm
Action: On August 13, 2026, O&M Halyard, Inc. issued a Urgent Medical Device Recall notification to affected consignees via E-Mail. O&M Halyard ask consignees to take the following actions: 1. REVIEW your inventory for the affected product code(s) and specific lot number(s). 2. DESTROY or DISCARD the product in accordance with the facility s standard disposal procedure. 3. COMMUNICATE the recall notification to your staff to ensure awareness of it. 4. If any of the affected lot(s) identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. 5. Any adverse events associated with the use of the affected product should be reported to complaints@owens minor.com. 6. RETURN the completed Field Action Response Form to [email protected] as soon as possible even if you have no current product inventory. 7. If credit is requested, please contact the Customer Service team and send email to GM-OMRA_RECALLS@owens minor.com.
Quantity in commerce: 452,500 units
Distribution: US Nationwide distribution in the states of GA, CA, NJ, MA, NY, NC.
Product codes and lots: REF: 48771/UDI: 30680651487712 (Package)20680651487715 (Primary)90680651487714 (Unit of Use) ; 48772/30680651487729 (Package)20680651487722 (Primary)90680651487721 (Unit of Use);48773/30680651487736 (Package)20680651487739 (Primary)90680651487738 (Unit of Use);48774/UDI: 30680651487743 (Package)20680651487746 (Primary) 90680651487745 (Unit of Use);48775/UDI:30680651487750 (Package)20680651487753 (Primary)90680651487752 (Unit of Use)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2230-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2230-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-03	2026-05-22

Product code LZC

K200019Class INitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)Hartalega NGC Sdn. Bhd. / cleared 2020-04-06

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)