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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 601–620 of 1,000 recalls

Class IITerminated

SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.

Microbiologics Inc

The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences).

August 20, 2021 · DeviceView details →

Class IITerminated

Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged

Greiner Bio-One North America, Inc.

Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.

August 20, 2021 · DeviceView details →

Class IITerminated

SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.

Microbiologics Inc

The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences.

August 20, 2021 · DeviceView details →

Class IITerminated

Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,

Philips Ultrasound Inc

Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power.

August 19, 2021 · DeviceView details →

Class IITerminated

Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,

Philips Ultrasound Inc

Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power.

August 19, 2021 · DeviceView details →

Class IITerminated

COVENA PICC Sleeve

Queen Comfort Products lLC

Marketed without FDA clearance

August 18, 2021 · DeviceView details →

Class IITerminated

CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general instrument intended for assisting surgeons in the manipulation of bone during surgical procedures.

In2bones USA, LLC

Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.

August 18, 2021 · DeviceView details →

Class IITerminated

EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160

Olympus Corporation of the Americas

A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.

August 17, 2021 · DeviceView details →

Class IITerminated

BF-XP60 OES Bronchofiberscope, Model No. BF-XP60

Olympus Corporation of the Americas

The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

August 16, 2021 · DeviceView details →

Class IITerminated

Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.

Biodex Medical Systems, Inc.

When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose measurement and/or misadministration

August 16, 2021 · DeviceView details →

Class IITerminated

BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180

Olympus Corporation of the Americas

The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

August 16, 2021 · DeviceView details →

Class IITerminated

BF-3C40 OES Bronchofiberscope, Model No. BF-3C40

Olympus Corporation of the Americas

The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

August 16, 2021 · DeviceView details →

Class IITerminated

BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160

Olympus Corporation of the Americas

The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

August 16, 2021 · DeviceView details →

Class IITerminated

AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332

Biodex Medical Systems, Inc.

August 16, 2021 · DeviceView details →

Class IITerminated

BF-1T60 OES Bronchofiberscope, Model No. BF-1T60

Olympus Corporation of the Americas

The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

August 16, 2021 · DeviceView details →

Class IITerminated

BF-N20 OES Bronchofiberscope, Model No. BF-N20

Olympus Corporation of the Americas

The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

August 16, 2021 · DeviceView details →

Class IITerminated

BF-P60 OES Bronchofiberscope, Model No. BF-P60

Olympus Corporation of the Americas

The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

August 16, 2021 · DeviceView details →

Class IITerminated

BF-Q180-AC EVIS EXERA II Bronchovideoscope, Model No. BF-Q180-AC

Olympus Corporation of the Americas

The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

August 16, 2021 · DeviceView details →

Class IITerminated

BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F

Olympus Corporation of the Americas

The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

August 16, 2021 · DeviceView details →

Class IITerminated

BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180

Olympus Corporation of the Americas

The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

August 16, 2021 · DeviceView details →

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