Sybron Recalls Pinnacle Cure Sleeves Due to Mislabeling and Cross-Contamination Risk
Sybron Dental Specialties is recalling 172 units of Pinnacle Cure Sleeves because inner packaging is mislabeled, creating a risk of cross-contamination if the sleeves tear.
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 source explicitly states there is a 'low risk' associated with the product and no illnesses or injuries are reported, fitting the criteria for a moderate severity recall involving labeling errors and theoretical contamination risks.
Plain-English summary
Sybron Dental Specialties is recalling 172 units of Pinnacle Cure Sleeve, Curing Light Tip Sleeves. The affected products are identified by Part Number 4513C or 4513-1 and Lot Number 2014030110. These sleeves are designed for single patient use and fit 13mm tips.
The recall was initiated because cases of the 13mm tip sleeves were found with inner boxes labeled with part number 4500, which are intended for 7mm and 8mm tips. This labeling discrepancy creates a low risk that the sleeve may tear during use, potentially leading to cross-contamination.
The affected products were distributed worldwide, including in the United States, Canada, Australia, the Netherlands, Switzerland, and Japan. Consumers and healthcare providers should stop using these specific sleeves and contact Sybron Dental Specialties for further instructions.
The recalled product
- 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…
- Manufacturer
- Sybron Dental Specialties
- Affected units
- 172
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 (1)
- Part Number: 4513C or 4513-1. Lot Number: 2014030110
Distribution
Distributed nationwide across the United States.
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