Class I - Dangerous
Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
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Infusion Pumps
🏥 Medical Devices • 4,262 recalls
Class I - Dangerous
Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incorrectly loaded and calibration will not be completed successfully.
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Beckman Coulter
Class I - Dangerous
Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused by sample-to-pack carryover predominantly into the particle well of the reagent pack by way of the probe. The particle well then becomes contaminated by the high sample from the probe. The extent of the carryover is dependent on sample concentration and frequency of high concentration samples.
Zoll, REF 8700-000871-40, Quattro (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
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.
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
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
The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.
Zoll, REF 8700-000872-40, SOLEX 7(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
Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.)
ZOLL Circulation
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Zoll, REF 8700-000869-40, Cool Line (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
Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator.
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
GE Healthcare
Class I - Dangerous
A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA).
Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002
Contamac Solutions
Class I - Dangerous
Contact lens solution may contain foreign material
Class I - Dangerous
The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.
Class I - Dangerous
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.