Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Outer cardboard box labeling: Pinnacle Cure Sleeve Recalled by Sybron Dental Specialties Due to Cases of Cure Sleeve labeled with part number...

Date: February 11, 2015
Company: Sybron Dental Specialties
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Sybron Dental Specialties directly.

Affected Products

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

Quantity: 172

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Sybron Dental Specialties

Sybron Dental Specialties has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report