FDA Device recall Z-2142-2014
INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc
- FDA Device
- Class III
- terminated
- Published 2014-08-13
On 2014-08-13 the FDA classified a Class III recall of INSIGHT Dental Film, Catalog Number/REF 811 0785, 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
| Agency | FDA Device |
|---|---|
| Recall number | Z-2142-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-07-02 |
| Published | 2014-08-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Carestream Health |
| Distribution | n/a |
Product
INSIGHT Dental Film, Catalog Number/REF 811 0785, 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_info | Lot Numbers: 53901201, 53801303, 53801303-1, 54601201, 54601201-1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2142-2014%22
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