Ultra-speed Dental Film — Class III medical device recall Z-2143-2014
Terminated recall by Carestream Health Inc., reported 2014-08-13. The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the
| Recall number | Z-2143-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health Inc., Rochester, NY, United States |
| Recall initiated | 2014-07-02 |
| Classified | 2014-08-01 |
| Reported by FDA | 2014-08-13 |
| Terminated | 2016-05-25 |
| Quantity | 1,633 boxes |
| Reason classes | labeling |
| Lot numbers | 333012, 33301201, 33301202, 33301203 |
| Model numbers | 834, 8658 |
Product
Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2143-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.