CLASS II Device recall · Reported 30 Dec 2015 · FDA Enforcement Report

Dressit-X, Radiopaque D recalled by Rainbow Specialty & Health

Rainbow Specialty & Health Products is recalling Dressit-X, Radiopaque D-545, distributed nationwide in the US. The recall was initiated on 18 Nov 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot - 5012, Exp-102016

Quantity recalled150

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0477-2016
FDA event ID: 72726
Recalling firm: Rainbow Specialty & Health Products, Markham, N/A
Classification: Class II
Status: Terminated
Recall initiated: 18 Nov 2015
FDA classified: 23 Dec 2015
Reported: 30 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Dental Devices

Timeline

18 Nov 2015	Recall initiated by company
23 Dec 2015	Classified by FDA	+35 days
30 Dec 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Virginia

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Lot - 5012, Exp-102016

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 72726

This product is part of a recall event; the main page for the event is Dressol-X, Radiopaque D recalled by Rainbow Specialty & Health.

Reported	Class	Recall	Company	Reason	Where
30 Dec 2015	CLASS II	Dressol-X, Radiopaque D recalled by Rainbow Specialty & Health	Rainbow Specialty & Health Products	Device Malfunction	Nationwide

More recalls from Rainbow Specialty & Health Products

All 2

Reported	Class	Recall	Company	Reason	Where
30 Dec 2015Device	CLASS II	Dressol-X, Radiopaque D recalled by Rainbow Specialty & Health	Rainbow Specialty & Health Products	Device Malfunction	Nationwide

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