Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

INSIGHT Dental Film Recalled by Carestream Health Inc. Due to The Indicator Dot on the film packet's outer...

Date: July 2, 2014
Company: Carestream Health Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Carestream Health Inc. directly.

Affected Products

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

Quantity: 1633 boxes

Why Was This Recalled?

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.

Where Was This Sold?

Worldwide Distribution.

About Carestream Health Inc.

Carestream Health Inc. has 61 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report