Outer cardboard box labeling: Pinnacle Cure Sleeve — Class II medical device recall Z-1291-2015
Terminated recall by Sybron Dental Specialties, reported 2015-03-25, distributed nationwide. Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part n
| Recall number | Z-1291-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sybron Dental Specialties, Orange, CA, United States |
| Recall initiated | 2015-02-11 |
| Classified | 2015-03-18 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2015-05-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, JP, NL |
| Quantity | 172 |
| Reason classes | labeling |
| Lot numbers | 2014030110 |
| Model numbers | 4500, 4513-1, 4513C |
Product
Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 4513-1 Single Patient Use Fits 13mm Tips. Pack of 400. Metrex Research, Manufacturer. Inner individual packaging of each sleeve: Cure Sleeve by Pinnacle Model 4500
Reason for recall
Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination.
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-1291-2015. 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.