January 22, 2025Medical DevicesFDA
A L I Technologies Ltd recalls Change Healthcare Cardiology Hemo software
Hazard: Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
January 22, 2025Medical DevicesFDA
A L I Technologies Ltd recalls McKesson Cardiology Hemo software
Hazard: Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
January 22, 2025Medical DevicesFDA
Murata Vios, Inc. recalls muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Hazard: During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor.
January 22, 2025Medical DevicesFDA
IsoTis OrthoBiologics, Inc. recalls OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc,
Hazard: Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-235
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A;
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25, Model Number 96-2224A;
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO S
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814;
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-413
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960;
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A,
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603;
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-411
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M;
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number 96-4921A
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286;
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-417
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-263
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOOK 1.5MM STERILE CS/25, Model Number 96-4020
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPATULA #24 STRL CS/25, Model Number 96-2245M,
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-224
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-242
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320;
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.
January 22, 2025Medical DevicesFDA
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-
Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.