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.
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, 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…
- Manufacturer
- Hager & Meisinger Gmbh
- Hazard
- 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
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