Danville Materials Recalls Perioscopy Sheaths Due to Unsupported Shelf-Life Labeling
Danville Materials is recalling Perioscopy Sheaths because validation data to support the 3-year shelf-life claim on the label is unavailable.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a labeling error regarding shelf-life without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Danville Materials, Inc. is recalling approximately 2,123 units of Perioscopy Sheaths (Part number 1008). The Perioscopy Sheath is a single-use sterile component used with the Perioscopy System, a medical device that features miniaturized digital video technology to allow healthcare professionals to view magnified details of tooth anatomy and deposits below the gum line.
The recall was initiated because the sheaths are currently labeled with a 3-year shelf-life and expiration date. Danville Materials has determined that validation data are not available to support this 3-year shelf-life and expiration dating claim.
The affected units were distributed in the United States, New Zealand, Australia, Canada, Japan, Israel, the United Kingdom, Italy, and Mexico. The specific lot numbers involved are 1133, 1135, 1136, 1137, 1138, 1163, 1171, 1172, 1173, 1174, 1175, 1218, 1240, 1243, 1258, 1264, 1264-1, 1275, 1276, 1277, 1311, 1314, 1315, 1325, and 1326.
The recalled product
- Product
- Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile component used with the Perioscopy System, which is a medical device that features miniaturized digital video technology, and enables the healthcare professional to see magnified details…
- Manufacturer
- Danville Materials, Inc.
- Hazard
- Affected units
- 2,123
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 (20)
- Part number 1008: Lot numbers: 1133
- 1135
- 1136
- 1137
- 1138
- 1163
- 1171
- 1172
- 1173
- 1174
- 1175
- 1218
- 1240
- 1243
- 1258
- 1264
- 1264-1
- 1275
- 1276
- 1277
Distribution
Distribution scope not specified by the agency.
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