Medical device recalls Moderate risk

Hager & Meisinger Gmbh recalls SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 - Product Usage: Cut…

Recall date
July 15, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2937-2020
FDA classification
Class II
Brand / firm
Hager & Meisinger Gmbh
Sold / distributed
US Nationwide distribution including in the states of AZ, CA, FL, IN, NY, PA and TX.

Why it was recalled

US-dates between the product package label and the bar code display.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 in the fabrication of dental devices.

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