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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72726

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

Open FDA event record

Event summary

Timeline bucket
November 18, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Rainbow Specialty & Health Products

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

Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol

Z-0476-2016
Recall number
Z-0476-2016
Initiated
November 18, 2015
Classification
Class II
Status
Terminated
Quantity
2775

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Rainbow Specialty & Health Products initiated a field action for Dressol-X and Dressit-X because the labeling does not currently list the percentage of drug components.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Rainbow Specialty & Health Products initiated a field action for Dressol-X and Dressit-X because the labeling does not currently list the percentage of drug components.

Code information

Lot-14317: Exp-052016; Lot-15007: Exp-102016, Lot-15140, Exp-122016

Distribution pattern

Nationwide. No foreign, govt/VA/military consignees.

device · product 2 of 2

Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil

Z-0477-2016
Recall number
Z-0477-2016
Initiated
November 18, 2015
Classification
Class II
Status
Terminated
Quantity
150

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Rainbow Specialty & Health Products initiated a field action for Dressol-X and Dressit-X because the labeling does not currently list the percentage of drug components.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Rainbow Specialty & Health Products initiated a field action for Dressol-X and Dressit-X because the labeling does not currently list the percentage of drug components.

Code information

Lot - 5012, Exp-102016

Distribution pattern

Nationwide. No foreign, govt/VA/military consignees.