A product recall is the process of retrieving defective and/or potentially unsafe goods from consumers while providing those consumers with compensation. Recalls often occur as a result of safety concerns over a manufacturing defect in a product that may harm its user. A product recall may be voluntary or mandated by a regulatory body.
Data from the first quarter of 2023 shows that the number of product recalls in the U.S. increased 14.2% from the previous quarter. The number of medical device recalls increased 4.6% to 252 events. While manufacturing defects accounted for the greatest proportion of these (with 59), quality concerns were the leading cause in terms of units impacted, with 68.5 million or 82.3% of all recalled devices.
Insulet Corporation announced a recall for two of its devices among the list of recalled medical devices.
Insulet Corporation announced a Medical Device Correction for the Omnipod 5 Automated Insulin Delivery System. Insulet has received 24 reports that the Omnipod 5 Controller charging port (USB-C port) or cable (USB cable) is melting, deforming, or discolouring due to heat generated by a poor cable connection. No serious injuries have been reported to Insulet as a result of this issue.
Insulet announced a voluntary recall for all Omnipod DASH Personal Diabetes Managers (PDMs) distributed globally. Insulet received reports from Omnipod DASH users regarding PDM battery issues, including battery swelling and leakage, and in rare cases, extreme overheating has resulted in reports of fire. The Company’s investigation determined that the Omnipod DASH PDM is at increased risk of malfunction if overcharged beyond the maximum battery voltage, which could potentially lead to serious injury or death.
BearCare Inc. initiated a voluntary recall of its rechargeable Walnut Wearable Smart Thermometer (Walnut Thermometer) due to reports of injuries, including skin burns, by users. The Walnut Thermometer is an over-the-counter rechargeable device intended for continuous chest temperature monitoring of children ages 0-6 years which can be identified by its silicone exterior resembling a cartoon penguin.
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