FDA Device Recalls

Class ITerminated

LiquaSonic Ultrasound Gel 5L, Model No. 001222

Athena Medical Products Inc

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.

August 20, 2021 · DeviceView details →

LiquaSonic Ultrasound Gel 5L, Model No. 001222

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

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.

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

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

COVENA PICC Sleeve

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.

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

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

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

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

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

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

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

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

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

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

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

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

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