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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94129

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

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Event summary

Timeline bucket
February 13, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
DeRoyal Industries 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

GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART

Z-1382-2024
Recall number
Z-1382-2024
Initiated
February 13, 2024
Classification
Class I
Status
Ongoing
Recalling firm
DeRoyal Industries Inc
Quantity
134 tracecarts

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.

Code information

a) 53-1831 ORTHO TOTAL JOINT TRACECART, GTIN 0749756598088, Lot Numbers: 57587017 exp 2/1/2024, 57760377 exp 2/1/2024, 58185167 exp 5/1/2024, 58628933 exp 6/1/2024, 58834059 exp 9/1/2024, 58864266 exp 7/1/2024, 59223364 exp 7/1/2024, 59355050 exp 2/1/2025, 59548003 exp 5/1/2025; b) 53-1836 GENERAL SURGERY TRACECART, GTIN 0749756598132, Lot Numbers: 58654875 exp 6/1/2024, 58736096 exp 6/1/2024, 59146688 exp 7/1/2024, 59223356 exp 7/1/2024, 59443367 exp 11/1/2024, 59510136 exp 11/1/2024, 59515455 exp 3/1/2025, 59661866 exp 5/1/2025

Distribution pattern

Florida