FDA Device recall Z-2143-2014
Ultra-speed Dental Film, Catalog Number/REF 834 8658, 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 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
| Agency | FDA Device |
|---|---|
| Recall number | Z-2143-2014 |
| 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
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_info | Lot 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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2143-2014%22
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