Perioscopy Sheath: Part number: 1008 — Class II medical device recall Z-2530-2016
Terminated recall by Danville Materials, Inc., reported 2016-08-24. The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/e
| Recall number | Z-2530-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Danville Materials, Inc., San Ramon, CA, United States |
| Recall initiated | 2016-06-24 |
| Classified | 2016-08-12 |
| Reported by FDA | 2016-08-24 |
| Terminated | 2016-12-09 |
| Countries outside the US | AU, CA, GB, IL, IT, JP, MX, NZ |
| Quantity | 2,123 units |
| Reason classes | labeling |
| Lot numbers | 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, 1326 |
| Model numbers | 1008 |
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 of the tooth anatomy and deposits below the gum line (i.e. calculus root fractures, restoration margins, tooth decay).
Reason for recall
The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date. Danville Materials has become aware that validation data are not available to support the 3-year shelf-life/expiration dating claim.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2530-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.