Class I - Dangerous
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Aesthetics Systems Usa
Class I - Dangerous
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.
Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay the final restoration.
Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay the final restoration.
Class I - Dangerous
The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.
Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
ZOLL Circulation
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Medtronic Perfusion Systems
Class I - Dangerous
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Flower Orthopedics
Class I - Dangerous
Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
Class I - Dangerous
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.
ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
DePuy Orthopaedics
Class I - Dangerous
Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing