RecallRadar

FDA Device recall Z-2143-2014

Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc

On 2014-08-13 the FDA classified a Class III recall of Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc by Carestream Health, citing 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 ca….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2143-2014
ClassificationClass III
Statusterminated
Initiated2014-07-02
Published2014-08-13
Last updated2026-09-13 11:53 UTC
CompanyCarestream Health
Distributionn/a

Product

Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.

Reason

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.

Identifiers

code_infoLot Numbers: 33301201, 33301202, 33301203, 333012 part unknown, 34301501

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Other recalls by Carestream Health

All Carestream Health recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2143-2014%22

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