The Recall Desk
ModerateFDA (Devices)·Z-2937-2020·Announced 2020-09-16

Hager & Meisinger Recalls Dental Burs Due to Labeling Discrepancy

Hager & Meisinger is recalling 144 units of SINGLES Carbide dental burs because the US dates on the package label do not match the bar code display.

What this means for you

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, and the source text identifies the issue as a labeling discrepancy (dates) without reporting any injuries or illnesses, fitting the criteria for a moderate severity labeling error.

Plain-English summary

Hager & Meisinger Gmbh is recalling 144 units of SINGLES Carbide US-No. FG556 dental burs (Lot R50753). These sterile, single-use instruments are intended for cutting hard structures in the mouth, such as teeth or bone, as well as hard metals, plastics, and porcelains used in dental device fabrication.

The recall was initiated because there are discrepancies between the US dates displayed on the product package label and the bar code. The affected units were distributed nationwide in the United States, including in Arizona, California, Florida, Indiana, New York, Pennsylvania, and Texas.

Dental professionals and patients who have used or possess these specific burs should stop using them and contact the manufacturer for further instructions.

The recalled product

Product
SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 - Product Usage: Cutting of hard structures in the mouth, such as teeth or bone, it is also intended to cut hard metals, plastics, porcelains, and similar materials intended for use
Affected units
144

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)

  • LOT R50753

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Same manufacturer · Hager & Meisinger Gmbh

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