The Recall Desk
LowFDA (Devices)·Z-0493-2020·Announced 2019-11-27

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.

What this means for you

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:
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

Distributed in 6 states:

Same manufacturer · Hager & Meisinger Gmbh

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