Class IOngoingZ-1958-2025
Integra LifeSciences Corp. (NeuroSciences) recalls Extended Tip Applicator
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Integra LifeSciences C…NJJul 2, 2025
Class I recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 469–480 of 634 recalls
Class IOngoingZ-1904-2025
SunMed Holdings, LLC recalls Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife)
The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone.…
SunMed Holdings, LLCMIJul 2, 2025
Class IOngoingZ-1946-2025
Dexcom, Inc. recalls Dexcom One Continuous Glucose Monitoring System
Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values.…
Dexcom, Inc.CAJun 25, 2025
Class IOngoingZ-1945-2025
Dexcom, Inc. recalls Dexcom One+ Continuous Glucose Monitoring System
Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values.…
Dexcom, Inc.CAJun 25, 2025
Class IOngoingZ-1944-2025
Dexcom, Inc. recalls Dexcom G7 Glucose Receiver
Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values.…
Dexcom, Inc.CAJun 25, 2025
Class IOngoingZ-1943-2025
Dexcom, Inc. recalls Dexcom G6 Glucose Receiver
Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values.…
Dexcom, Inc.CAJun 25, 2025
Class IOngoingZ-1902-2025
Cook Incorporated recalls Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and ther…
Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
Cook IncorporatedINJun 25, 2025
Class IOngoingZ-1915-2025
Covidien recalls Newport HT70 Ventilator
Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or…
CovidienCAJun 18, 2025
Class IOngoingZ-1869-2025
Fresenius Kabi USA, LLC recalls IVENIX INFUSION SYSTEM LVP Blood Products Administration Set
Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
Fresenius Kabi USA, LL…MAJun 18, 2025
Class IOngoingZ-1868-2025
Zyno Medical LLC recalls Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids
Unreleased software versions were installed on distributed devices without verification or validation.
Zyno Medical LLCMAJun 18, 2025
Class IOngoingZ-1867-2025
Zyno Medical LLC recalls Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids
Unreleased software versions were installed on distributed devices without verification or validation.
Zyno Medical LLCMAJun 18, 2025
Class IOngoingZ-1866-2025
Zyno Medical LLC recalls Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids
Unreleased software versions were installed on distributed devices without verification or validation.
Zyno Medical LLCMAJun 18, 2025