FDA (Devices) recall action 92920
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
MEDLINE INDUSTRIES is recalling ReNewal Ligasure Sealer/Divider electrosurgical instruments due to incomplete seals on packaging trays. The recall affects 268 units distributed in the United States.
Medline is recalling 58 units of ReNewal Ligasure Maryland Jaw Sealer electrosurgical instruments due to incomplete seals on packaging trays that may allow contamination during reprocessing.
MEDLINE ReNewal Harmonic ACE+7 surgical shears may have incomplete seals on packaging trays. Approximately 18 units were distributed in the United States. Affected products should not be used.
Medline is recalling 11 reprocessed Covidien LigaSure and Ethicon Harmonic electrosurgical devices due to incomplete seals on their packaging trays.