Class IOngoingZ-1960-2025
Integra LifeSciences Corp. (NeuroSciences) recalls Extended Tip Applicator 8CM
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Integra LifeSciences C…NJJul 2, 2025
Recalls: Process change control
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 109–120 of 185 recalls
Class IOngoingZ-1959-2025
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 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 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 IIOngoingZ-1924-2025
Medtronic, Inc. recalls Azure S DR MRI SureScan
Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy.…
Medtronic, Inc.MNJun 18, 2025
Class IIOngoingZ-1663-2025
IHB OPERATIONS B.V. recalls Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread engagement to support the weight of the frame and monitor.…
IHB OPERATIONS B.V.Apr 30, 2025
Class IIOngoingZ-1576-2025
Abbott Diagnostics Scarborough, Inc. recalls Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 S…
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Abbott Diagnostics Sca…MEApr 23, 2025
Class IIOngoingZ-1575-2025
Abbott Diagnostics Scarborough, Inc. recalls Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/C…
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Abbott Diagnostics Sca…MEApr 23, 2025
Class IIOngoingZ-1574-2025
Abbott Diagnostics Scarborough, Inc. recalls Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog…
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
- Process change control
Abbott Diagnostics Sca…MEApr 23, 2025
Class IIOngoingZ-1573-2025
Abbott Diagnostics Scarborough, Inc. recalls Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 S…
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Abbott Diagnostics Sca…MEApr 23, 2025
Class IIOngoingZ-1572-2025
Abbott Diagnostics Scarborough, Inc. recalls Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/C…
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Abbott Diagnostics Sca…MEApr 23, 2025
Class IIOngoingZ-1571-2025
Abbott Diagnostics Scarborough, Inc. recalls Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog…
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
- Process change control
Abbott Diagnostics Sca…MEApr 23, 2025