Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin…
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare…
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5…
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5…
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare…
Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion…
Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin…
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare…
There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close…
Class IFDA: OngoingOlympus Corporation of the Americas
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare…
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5…
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5…
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5…
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5…
There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close…
Class IFDA: OngoingOlympus Corporation of the Americas
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5…
There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close…
Class IFDA: OngoingOlympus Corporation of the Americas
Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System.
Class IIFDA: OngoingSecuritas Healthcare LLC
About the 2023 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.