FDA Device recall Z-1291-2015
Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves
- FDA Device
- Class II
- terminated
- Published 2015-03-25
On 2015-03-25 the FDA classified a Class II recall of Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves by Sybron Dental Specialties, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1291-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-11 |
| Published | 2015-03-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Sybron Dental Specialties |
| Distribution | US |
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
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.
Identifiers
| code_info | Part Number: 4513C or 4513-1. Lot Number: 2014030110 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1291-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.