The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2069-2017·Announced 2017-05-17

Almore Microfil Composite Instruments Recalled for Incorrect Sterile Labeling

Almore International Inc. is recalling Microfil Composite Instruments because packaging labels incorrectly display a sterile symbol, although the devices are not sterile.

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 recall is classified as FDA Class II, but the hazard is a labeling error regarding sterility status rather than a structural defect or contamination, fitting the criteria for moderate severity involving minor labeling errors.

Plain-English summary

Almore International Inc. is recalling Microfil Composite Instruments due to a labeling error. The packaging label inserts for these instruments display a sterile symbol, which indicates that the products are sold as sterile devices. However, the source text clarifies that these products are not sterile and are intended to be sterilized by the dentist prior to each use.

The recall involves 1,773 devices, with 1,570 distributed in the United States and 203 distributed internationally. The affected models include #96041 Gold Microfil, #96042 Green Microfil, #96043 Blue Microfil, and #96044 Set of 3 Microfil. These instruments are used for composite restoration development, specifically to shape light-cured composites and contour tooth surfaces.

The devices were distributed worldwide, including nationwide in the US across states such as AZ, CA, CO, CT, FL, GA, IA, IL, IN, MA, MN, MO, NC, NJ, NV, NY, OH, PA, TN, TX, WA, and WI, as well as in Canada, the Netherlands, and South Korea. No lot codes are associated with this recall. Consumers and dental professionals should stop using these instruments and contact the recalling firm for instructions.

The recalled product

Product
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…
Manufacturer
Almore International Inc
Category
Medical Device — Dental Instruments
Hazard

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)

  • no lot codes

Distribution

Distributed nationwide across the United States.

The notice also names 22 states specifically:

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