FDA Medical Device Recalls (openFDA)
Carestream Health Inc.: Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
- Recall number
- Z-2143-2014
- Recalling firm
- Carestream Health Inc.
- Product
- Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
- Status
- Terminated
- Initiated
- 2014-07-02
- Posted
- 2014-08-01
- Terminated
- 2016-05-25
- 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.
- Root cause
- Package design/selection
- Action
- Recall notices were mailed to US Customers via overnight carrier on 07/02/2014. Customers are asked to complete an inventory of goods to be returned which will be ultimately destroyed by recalling company. If you have any questions or concerns, please contact the Carestream Customer Care Center in the U.S. at 1-800-933-8031.
- Quantity
- 1633 boxes
- Distribution
- Worldwide Distribution.
- Lot, serial or model codes
- Lot Numbers: 33301201, 33301202, 33301203, 333012 part unknown, 34301501
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IWZ
- Firm FEI
- 1315356
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28