Medical device recalls Moderate risk

Southmedic product recalled over sterility concerns

Recall date
November 6, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Southmedic, Inc. recalls Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for prepar…
Recall number
Z-1892-2018
FDA classification
Class II
Brand / firm
Southmedic, Inc.
Sold / distributed
US Distribution to the states of : IA, IL, NE, NY and TX

Why it was recalled

Scalpels lot contains non-sterile products labeled as sterile.

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

What was recalled

Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.

Get recall alerts

Free email alert whenever Southmedic, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Southmedic, Inc.