CLASS III Device recall · Reported 13 Aug 2014 · FDA Enforcement Report

Insight Dental Film recalled by Carestream Health

Carestream Health is recalling Insight Dental Film. The recall was initiated on 2 Jul 2014 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot Numbers: 53901201, 53801303, 53801303-1, 54601201, 54601201-1

Quantity recalled1633 boxes

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-2142-2014
FDA event ID: 68647
Recalling firm: Carestream Health, Rochester, NY
Classification: Class III
Status: Terminated
Recall initiated: 2 Jul 2014
FDA classified: 1 Aug 2014
Reported: 13 Aug 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Dental Devices

Timeline

2 Jul 2014	Recall initiated by company
1 Aug 2014	Classified by FDA	+30 days
13 Aug 2014	Published in enforcement report	+12 days

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

Reason for recall

The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may cause confusion for the dental practitioner. If the processed film is placed on the view box by referencing the film's raised dot, the image orientation will be rotated 180 degrees.

Product as listed by the FDA

INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.

Where it was distributed

Worldwide Distribution.

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Numbers: 53901201, 53801303, 53801303-1, 54601201, 54601201-1

Where was it sold?

Worldwide Distribution.

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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 68647

Reported	Class	Recall	Company	Reason	Where
13 Aug 2014	CLASS III	Ultra-speed Dental Film recalled by Carestream Health	Carestream Health	Other	NY

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1 May 2019Device	CLASS II	OnSight 3D Extremity System- X-Ray, Tomography Computed System recalled	Carestream Health	Other	Nationwide

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