Hager & Meisinger Recalls Dental Carbide Burs Due to Packaging Error
Hager & Meisinger is recalling 2,500 dental carbide burs because a 1.0 mm blade may have been packaged in 0.9 mm packaging.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a packaging-only problem (incorrect size labeling) with no reported injuries or illnesses.
Plain-English summary
Hager & Meisinger Gmbh is recalling 2,500 units of Singles carbide burs (US-No: 245, Reference: HMUN245-009) due to a packaging error. The recall is limited to Lot #R23891.
The recall was initiated because there is a potential that a 1.0 mm carbide blade was packaged in a 0.9 mm carbide blade packaging. This discrepancy could lead to the use of an incorrect bur size during dental procedures.
The affected products were distributed in Nevada, Pennsylvania, Florida, South Carolina, Iowa, and North Carolina. Dental professionals should stop using the affected burs and contact the manufacturer for further instructions.
The recalled product
- Product
- Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/10mm: 009,Head Length/mm:
- Manufacturer
- Hager & Meisinger Gmbh
- Hazard
- Affected units
- 2,500
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 #R23891 UDI: +E0HM26UN2453140099/$$8250523R23891+
Distribution
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