🏥 Medical Devices • 4,350 recalls
GE Healthcare
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
Ion Beam Applications S.A.
First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed
Busse Hospital Disposables
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Busse Hospital Disposables
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.
Busse Hospital Disposables
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
XVIVO PERFUSION AB
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
Busse Hospital Disposables
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
Reports received of torn corrugated breathing tubes.
International Science & Technology, LP
Surgical knives may contain incorrect description printed on handles. Specifically, some surgical knife handles may contain a size of "2.5mm" when the actual size is "2.2mm".
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
The device may emit smoke or ignite.
Reports received of torn corrugated breathing tubes.
Baxter Healthcare
Firm discovered a firmware memory leak with a supplier-manufactured component.
Clinician's Choice Dental Products
Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK
Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International, that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products.
Baxter Healthcare
Firm discovered a firmware memory leak with a supplier-manufactured component.
First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer.
There is a potential for foreign matter.