Carestream Recalls INSIGHT Dental Film Due to Indicator Dot Misplacement
Carestream Health Inc. is recalling INSIGHT Dental Film because the indicator dot on the packaging is misaligned, which may cause dental practitioners to view images upside down.
What this means for you
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, which by definition is unlikely to cause adverse health consequences. The hazard is a labeling error that causes image orientation confusion, not a direct physical or chemical health risk.
Plain-English summary
Carestream Health Inc. is recalling INSIGHT Dental Film, Catalog Number/REF 811 0785, with KODAK and Carestream DENTAL labels. The recall involves 1,633 boxes distributed worldwide. The specific lot numbers affected are 53901201, 53801303, 53801303-1, 54601201, and 54601201-1.
The recall was initiated because the Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to 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 using the film's raised dot as a reference, the image orientation will be rotated 180 degrees.
Dental practitioners and consumers should check their inventory for the specific lot numbers listed above. If the product is found, it should be removed from use and returned to the supplier or Carestream Health Inc. for further instructions.
The recalled product
- Product
- INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
- Manufacturer
- Carestream Health Inc.
- Category
- Medical Device — Dental Imaging
- 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: 53901201
- 53801303
- 53801303-1
- 54601201
- 54601201-1
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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