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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-08-15NAINo action indicatedEthicon, Inc.0
2025-08-15NAINo action indicatedEthicon, Inc.0
2025-02-26NAINo action indicatedEthicon, Inc.0
2025-02-26NAINo action indicatedEthicon, Inc.0
2021-02-24NAINo action indicatedEthicon, LLC0
2021-02-24NAINo action indicatedEthicon, LLC0
2018-12-19VAIVoluntary action indicatedEthicon, Inc.0
2018-12-19VAIVoluntary action indicatedEthicon, Inc.0
2017-09-14VAIVoluntary action indicatedEthicon, Inc.7
2015-09-24NAINo action indicatedEthicon Inc0
2015-09-24NAINo action indicatedEthicon Inc0
2015-06-16NAINo action indicatedEthicon, LLC0
2015-06-16NAINo action indicatedEthicon, LLC0
2015-04-24NAINo action indicatedEthicon, LLC0
2015-04-24NAINo action indicatedEthicon, LLC0
2015-04-24VAIVoluntary action indicatedEthicon, Inc.2
2015-03-05NAINo action indicatedJohnson & Johnson Medical GMBH0
2014-02-20NAINo action indicatedEthicon Sarl, a Johnson & Johnson Company0
2013-08-30VAIVoluntary action indicatedEthicon, Inc.0
2012-03-21NAINo action indicatedEthicon, Inc.0
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