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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83411

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

Open FDA event record

Event summary

Timeline bucket
July 22, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
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

DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF 54-2465R, 6.5 FR x 24" Polyurethane c) REF 54-2480R, 8 FR x 24" Polyurethane d) REF 54-3680R, 8 FR x 36" Polyurethane Product Usage: Feeding tube

Z-2293-2019
Recall number
Z-2293-2019
Initiated
July 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
DeRoyal Industries Inc
Quantity
180 cases of 10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube.

Code information

a) REF 54-2450R, Lot Numbers: 142844, 143130 b) REF 54-2465R, Lot Numbers: 142843 c) REF 54-2480R, Lot Numbers: 142870 d) REF 54-3680R, Lot Numbers: 142842

Distribution pattern

US Nationwide Distribution in the states of N, TX, IL OH, NM, UT. NB, KY, CO