Class II — Potential Health Hazard

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

Microfil Composite Instruments are packaged in an unsealed plastic sleeve Recalled by Almore International Inc Due to Microfil Composite Instruments were distributed with a sterile...

Date: April 20, 2017
Company: Almore International Inc
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 Almore International Inc directly.

Affected Products

Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a cardboard box. Microfil Composite Instruments are intended to be sterilized by the dentist prior to each use. It is used for composite restoration development. The thin paddles shape light-cured composites. Paddles slide under the gum line to shape the margin. The flat ends contour the surfaces of the teeth and the thin edge is used to create esthetic highlights. Models: #96041  Gold Microfil #96042  Green Microfil #96043  Blue Microfil #96044  Set of 3 Microfil (Gold, Green, Blue)

Quantity: 1773 devices (US =1570; International = 203)

Why Was This Recalled?

Microfil Composite Instruments were distributed with a sterile symbol on their packaging label inserts, indicating that the products are sold as sterile devices. These products are not sterile and they are intended to be sterile prior to each use.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Almore International Inc

Almore International Inc has 1 total recall tracked by RecallDetector.

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