Medical devices are essential to patient safety, addressing critical issues in devices that may pose health risks.
Here are some of the latest recalls reported to the FDA:
Integra LifeSciences has recalled certain Codman Disposable Perforators and Craniotomy kits due to a weld defect that may cause the device to disassemble before, during or after use. This issue may result in damage to the dura, bleeding, cerebral injury or irreversible brain damage. Ten injuries have been reported. Users are advised to stop using the product, quarantine inventory and return affected lots.
Drive DeVilbiss Healthcare is recalling certain DV6X-619 Rev E DC car adapter cords used with the iGo2 Portable Oxygen Concentrator after reports of the cords becoming hot or melting during use. The issue may result in burns or thermal injuries; as a result, users were advised to destroy impacted cords and request free replacements through the company’s recall website. Two injuries have been reported.
Dexcom has recalled certain models of its G6, G7, ONE and ONE+ glucose monitor receivers because of a speaker malfunction that could prevent critical audio alerts from sounding. Affected units may fail to warn users about dangerously low or high blood glucose levels, posing a risk of seizures, unconsciousness or death. Dexcom has urged customers to test the speaker during charging, check their device serial number online and request a free replacement if needed. At least 56 injuries have been reported.
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