Halyard Purezero Ultraviolet Nitrile Glove Recall Update: Check Refs 48771-48775

Status: Open FDA Class II recall confirmed; the cause remains under investigation and the record may be updated. The Food and Drug Administration updated its recall record on August 13, 2026. The update says buyers got an urgent notice for Halyard Purezero Ultraviolet Nitrile Exam Gloves. The gloves failed chemical-permeation performance standards.

The recall did not start on August 13. FDA’s record says O&M Halyard Inc. began it on April 13. The agency posted it on May 22. The August 13 entry covers the urgent notice and is the latest update in the official record. Keeping the dates apart stops an update from being reported as a new recall.

Which gloves are listed

The FDA lists recall number Z-2230-2026 and event 98805. It also lists 510(k) K200019 and product code LZC. The affected Halyard Purezero glove references and sizes are:

• 48771 – extra small
• 48772 – small
• 48773 – medium
• 48774 – large
• 48775 – extra large

The record lists 452,500 units. They went to California, Georgia, Massachusetts, North Carolina, New Jersey, and New York. It names the maker as O&M Halyard Inc., FEI 3014421917. A buyer or site should compare its stock with the official record. It should not assume every Halyard glove is part of the recall.

What the August 13 notice requires

FDA’s database says the urgent notice tells buyers to review stock. They must destroy or discard affected product. They must also tell staff and later buyers, report adverse events, and return the response form. A site that moved the product must do more than check one room. Each later buyer needs the same product details.

The agency lists the recall as Class II. FDA uses that class when a product may cause short-term or reversible harm. It can also apply when the chance of serious harm is remote. That broad class does not prove an injury happened in this recall. The official record cited here gives no injury count.

Why this deserves a documented inventory check

Medical gloves can guard workers from chemical exposure. A failed test calls for a clear paper trail. Sites should identify affected references, record the number removed, tell each later buyer, and keep the recall reply. Sending a notice alone does not prove all 452,500 units were fixed or removed.

FDA marks the recall open. That means not all affected product has been fixed or removed. The database says the firm is still looking for the cause, and that cause may change. BadPD does not claim every listed glove failed in use. It does not claim all Halyard gloves are affected or that this recall caused an injury.

What remains unknown

• Which lots or customer facilities still hold affected inventory.
• How many of the 452,500 units have been destroyed, discarded, or otherwise corrected.
• The firm’s final root-cause determination.
• Whether FDA will add adverse-event counts or change the recall status.

Health sites and sellers should follow the official notice and their own safety steps. They can report adverse events through FDA MedWatch. This article is a public-record alert. It is not medical advice or a substitute for the maker’s instructions.

Official sources

• FDA recall record, last updated August 13, 2026
• FDA medical-device recall information
• FDA MedWatch reporting program