Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 229–240 of 439 recalls
The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App softwa…
Antivirus software was not consistently installed on impacted devices during the implementation process.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a…
Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural del…
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Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow.