Carestream Recalls Ultra-speed Dental Film Due to Indicator Dot Misalignment
Carestream Health Inc. is recalling 1,633 boxes of Ultra-speed Dental Film because the indicator dot is incorrectly positioned, which may cause image orientation errors.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, and the hazard involves labeling confusion leading to image orientation errors rather than direct physical injury or adverse health consequences.
Plain-English summary
Carestream Health Inc. is recalling 1,633 boxes of Ultra-speed Dental Film, Catalog Number/REF 834 8658, with KODAK and Carestream DENTAL labels. The affected lot numbers are 33301201, 33301202, 33301203, 333012 (part unknown), and 34301501. The product was distributed worldwide.
The recall was initiated because 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 misalignment may cause confusion for dental practitioners. If a practitioner places the processed film on a view box by referencing the film's raised dot, the image orientation will be rotated 180 degrees.
Dental practitioners and consumers who have these specific lot numbers should stop using the product and contact Carestream Health Inc. for further instructions.
The recalled product
- Product
- Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
- Manufacturer
- Carestream Health Inc.
- Category
- Medical Device — Dental Film
- Hazard
- Affected units
- 1,633
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot Numbers: 33301201
- 33301202
- 33301203
- 333012 part unknown
- 34301501
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Carestream Health Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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