Medical device recalls Moderate risk

M.D.L. S.r.l. recalls General Manual surgical instrument

Recall date
August 5, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2493-2021
FDA classification
Class II
Brand / firm
M.D.L. S.r.l.
Sold / distributed
Nationwide

Why it was recalled

Sterility assurance may be compromised.

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

What was recalled

General Manual surgical instrument

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