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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93306

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 19, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
MEDLINE INDUSTRIES, LP - Northfield

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

3 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 3

Medline Leg bag, REF DYND12574

Z-0533-2024
Recall number
Z-0533-2024
Initiated
October 19, 2023
Classification
Class II
Status
Ongoing
Quantity
28942 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Undeclared latex

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Undeclared latex

Code information

UDI/DI 40080196990338 (case), 10080196990337 (insert), Lot Numbers: 48623040001, 48623050001, 48623060001, 48623080001

Distribution pattern

US and Panama

device · product 2 of 3

Medline Leg bag, REF DYND12578

Z-0534-2024
Recall number
Z-0534-2024
Initiated
October 19, 2023
Classification
Class II
Status
Ongoing
Quantity
19406 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Undeclared latex

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Undeclared latex

Code information

UDI/DI 40080196990321 (case), 10080196990320 (insert), Lot Numbers: 48623040001, 48623050001, 48623060001, 48623070001, 48623080001

Distribution pattern

US and Panama

device · product 3 of 3

Medline Leg bag, REF URO12573

Z-0535-2024
Recall number
Z-0535-2024
Initiated
October 19, 2023
Classification
Class II
Status
Ongoing
Quantity
144 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Undeclared latex

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Undeclared latex

Code information

UDI/DI 20888277719290 (case), 10888277719293 (insert), Lot Numbers: 48623050001, 48623060001

Distribution pattern

US and Panama