January 29, 2025Medical DevicesFDA
St. Jude Medical recalls Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" H
Hazard: Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.
January 29, 2025Medical DevicesFDA
Medtronic Perfusion Systems recalls Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
Hazard: Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
January 29, 2025Medical DevicesFDA
Medtronic Perfusion Systems recalls EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Hazard: Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
January 29, 2025Medical DevicesFDA
Medtronic Perfusion Systems recalls DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Hazard: Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
January 29, 2025Medical DevicesFDA
O&M HALYARD, INC. recalls Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Descript
Hazard: Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
January 29, 2025Medical DevicesFDA
Stryker Corporation recalls stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery
Hazard: There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).
January 29, 2025Medical DevicesFDA
Stryker Corporation recalls stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
Hazard: There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).
January 29, 2025Medical DevicesFDA
Stryker Corporation recalls The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neuro
Hazard: There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains a 5820-107-530 device).
January 29, 2025Medical DevicesFDA
Integra LifeSciences Corp. recalls CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides
Hazard: Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
January 29, 2025Medical DevicesFDA
Integra LifeSciences Corp. recalls CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provid
Hazard: Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
January 29, 2025Medical DevicesFDA
Integra LifeSciences Corp. recalls CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides
Hazard: Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
January 29, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis Med 4000 Auxiliary (AUX), REF 314
Hazard: Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
January 29, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis Med ES Auxiliary (AUX), REF 343
Hazard: Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
January 29, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation 4000 AUX, REF 306
Hazard: Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
January 29, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation 4000 Main, REF 303
Hazard: Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
January 29, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation ES AUX, REF 324
Hazard: Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
January 29, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation ES (Med ES Main), REF 323
Hazard: Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
January 29, 2025Medical DevicesFDA
Adept Medical Ltd recalls Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
Hazard: Lack of 510(k) clearance.
January 29, 2025Medical DevicesFDA
Adept Medical Ltd recalls Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
Hazard: Lack of 510(k) clearance.
January 29, 2025Medical DevicesFDA
Adept Medical Ltd recalls Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;
Hazard: Lack of 510(k) clearance.
January 29, 2025Medical DevicesFDA
Adept Medical Ltd recalls Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
Hazard: Lack of 510(k) clearance.
January 29, 2025Medical DevicesFDA
Adept Medical Ltd recalls Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Hazard: Lack of 510(k) clearance.
January 29, 2025Medical DevicesFDA
Adept Medical Ltd recalls Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
Hazard: Lack of 510(k) clearance.
January 29, 2025Medical DevicesFDA
Adept Medical Ltd recalls Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
Hazard: Lack of 510(k) clearance.
January 29, 2025Medical DevicesFDA
Adept Medical Ltd recalls Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
Hazard: Lack of 510(k) clearance.
January 29, 2025Medical DevicesFDA
Percussionaire Corporation recalls VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single P
Hazard: Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.
January 29, 2025Medical DevicesFDA
Jinan Bodor Cnc Machine Co Ltd recalls Bodor P and C series laser cutting machines
Hazard: Non-compliant laser products
January 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V u
Hazard: Potential for distal tip tearing of the Mechanical Lithotriptor V.
January 22, 2025Medical DevicesFDA
Accriva Diagnostics, Inc. recalls VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Hazard: Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibition formula in the notice to manually calculate the percentage of platelet aggregation inhibition for a given patient receiving drug treatment with P2Y12 receptor inhibitor.
January 22, 2025Medical DevicesFDA
A L I Technologies Ltd recalls Change Healthcare Cardiology Hemodynamics software
Hazard: Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).