Class I - Dangerous
Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
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Infusion Pumps
🏥 Medical Devices • 4,262 recalls
Reports received of torn corrugated breathing tubes.
Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle Labeling; 2.5mm slit double bevel
International Science & Technology, LP
Class I - Dangerous
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".
Sara Plus Active Floor Lift
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Class I - Dangerous
The device may emit smoke or ignite.
Class I - Dangerous
Reports received of torn corrugated breathing tubes.
Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
Baxter Healthcare
Class I - Dangerous
Firm discovered a firmware memory leak with a supplier-manufactured component.
Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912
Clinician's Choice Dental Products
Class I - Dangerous
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.
NaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
Baxter Healthcare
Class I - Dangerous
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.
Class I - Dangerous
There is a potential for foreign matter.
Class I - Dangerous
Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue.
Class I - Dangerous
Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue.
Class I - Dangerous
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
Class I - Dangerous
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
Class I - Dangerous
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
Class I - Dangerous
QC process was not adequate for the specification range.
Class I - Dangerous
False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.
Inactivated macrolide-resistant Mycoplasma genitalium
Microbiologics
Class I - Dangerous
The QC process was not adequate for the specification range.