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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94769

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

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Event summary

Timeline bucket
May 13, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
SVS LLC

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

Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The range of sizes includes small, medium, large, and extra-large.

Z-2320-2024
Recall number
Z-2320-2024
Initiated
May 13, 2024
Classification
Class II
Status
Ongoing
Recalling firm
SVS LLC
Quantity
155,540 inner boxes

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and mislabeled products (e.g., outer box indicating one size, but inner box indicating another size).

Code information

Item Numbers: size XS - D5061/lot number: AEAM1105/UDI: 00811220035433; size S - D5062/lot number: AEAM1103,AEAM1104,AEAM1105,AEAM1106,AEAN0204,AEAN0205,AEAN0206,AEAN0307,AEAN0308,AEAN0309,AEAN0310,AEAN0311,AEAN0312,AEAN0316,AEAN0317,AEAN0318/ UDI: 00811220035440; size M - D5063/lot number: AEAM1104,AEAM1105,AEAM1112,AEAN0204,AEAN0205,AEAN0206,AEAN0307,AEAN0308,AEAN0309,AEAN0311,AEAN0312,AEAN0316,AEAN0317,AEAN0318,AEAN0319,AEAN0320,AEAN0206/UDI: 00811220035457; size L - D5064/lot number: AEAM1103,AEAM1104,AEAM1106,AEAN0204,AEAN0205,AEAN0206,AEAN0307,AEAN0308,AEAN0309,AEAN0310,AEAN0311,AEAN0312,AEAN0317,AEAN0318,AEAN0319,AEAN0320/UDI: 00811220035464; and size XL D5065/lot number: AEAN0204,AEAN0205,AEAN0206,AEAN0308,AEAN0310,AEAN0311/UDI: 00811220035471

Distribution pattern

US Nationwide distribution in the states of MI, NE, FL, GA, PA, AR, CO, and NY.