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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88846

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 27, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
O&M HALYARD INC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0317-2022
Recall number
Z-0317-2022
Initiated
September 27, 2021
Classification
Class II
Status
Ongoing
Recalling firm
O&M HALYARD INC
Quantity
2,928 cases (5,856,000 gloves)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide distribution - US Nationwide and the countries of EU/Canada.