Z-2143-2014Class III

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

Name: Z-2143-2014 Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream...
Creator: Carestream Health Inc.
Published: 2014-07-02
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2014-07-02 / Terminated / root cause: packaging

FDA source

Carestream Health Inc. began a recall of Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc on 2014-07-02. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2143-2014
Classification: Class III
Status: Terminated
Initiated: 2014-07-02
Posted: 2014-08-01
Terminated: 2016-05-25
Recalling firm: Eastman Kodak Company
Product: Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
Product code: IWZ Film, Radiographic
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.
Root cause tag: packaging
FDA 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 in commerce: 1633 boxes
Distribution: Worldwide Distribution.
Product codes and lots: Lot Numbers: 33301201, 33301202, 33301203, 333012 part unknown, 34301501

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2143-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2142-2014	Class III	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-01
Z-2143-2014	Class III	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-01

Product code IWZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)