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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69319

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

Open FDA event record

Event summary

Timeline bucket
August 22, 2014
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

2 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 2

Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, NON-STERILE, Rx Only general hospital

Z-0097-2015
Recall number
Z-0097-2015
Initiated
August 22, 2014
Classification
Class II
Status
Terminated
Recalling firm
DeRoyal Industries Inc
Quantity
13,900 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.

Code information

1) DeRoyal(R), REF 71-6510, Lot 36408631 2) NOVAPLUS(TM) Cat. No. V71-6510, Lot 36408622

Distribution pattern

Nationwide Distribution including MI, OH, IN, FL, WV, VA, MI, NC, and NY

device · product 2 of 2

DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital

Z-0098-2015
Recall number
Z-0098-2015
Initiated
August 22, 2014
Classification
Class II
Status
Terminated
Recalling firm
DeRoyal Industries Inc
Quantity
5112 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.

Code information

Lot 364817213

Distribution pattern

Nationwide Distribution including MI, OH, IN, FL, WV, VA, MI, NC, and NY