Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-01-29FDA-DeviceSt. Jude MedicalClass IIMerlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100) The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.
Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.
- 2025-01-29FDA-DeviceMedtronic Perfusion SystemsClass IISelect Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
- 2025-01-29FDA-DeviceMedtronic Perfusion SystemsClass IIEOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
- 2025-01-29FDA-DeviceMedtronic Perfusion SystemsClass IIDLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
- 2025-01-29FDA-DeviceO&M HALYARD, INC.Class IIBrand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
- 2025-01-29FDA-DeviceStryker CorporationClass IIstryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery
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).
- 2025-01-29FDA-DeviceStryker CorporationClass IIstryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
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).
- 2025-01-29FDA-DeviceStryker CorporationClass IIThe 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/ Otorhinolaryngology, orthopedic, and general surgical applications including maxillofacial and craniofacial surgeries. The 3.0MM Prec Neuro Match Head bur (5820-107-530) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spi
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).
- 2025-01-29FDA-DeviceIntegra LifeSciences Corp.Class IICODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
- 2025-01-29FDA-DeviceIntegra LifeSciences Corp.Class IICODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
- 2025-01-29FDA-DeviceIntegra LifeSciences Corp.Class IICODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
- 2025-01-29FDA-DeviceCareFusion 303, Inc.Class IIBD Pyxis Med 4000 Auxiliary (AUX), REF 314
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,
- 2025-01-29FDA-DeviceCareFusion 303, Inc.Class IIBD Pyxis Med ES Auxiliary (AUX), REF 343
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,
- 2025-01-29FDA-DeviceCareFusion 303, Inc.Class IIBD Pyxis MedStation 4000 AUX, REF 306
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,
- 2025-01-29FDA-DeviceCareFusion 303, Inc.Class IIBD Pyxis MedStation 4000 Main, REF 303
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,
- 2025-01-29FDA-DeviceCareFusion 303, Inc.Class IIBD Pyxis MedStation ES AUX, REF 324
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,
- 2025-01-29FDA-DeviceCareFusion 303, Inc.Class IIBD Pyxis MedStation ES (Med ES Main), REF 323
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,
- 2025-01-29FDA-DeviceAdept Medical LtdClass IIOtological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
Lack of 510(k) clearance.
- 2025-01-29FDA-DeviceAdept Medical LtdClass IIOtological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
Lack of 510(k) clearance.
- 2025-01-29FDA-DeviceAdept Medical LtdClass IIOtological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;
Lack of 510(k) clearance.
- 2025-01-29FDA-DeviceAdept Medical LtdClass IIOtological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
Lack of 510(k) clearance.
- 2025-01-29FDA-DeviceAdept Medical LtdClass IIOtological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Lack of 510(k) clearance.
- 2025-01-29FDA-DeviceAdept Medical LtdClass IIOtological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
Lack of 510(k) clearance.
- 2025-01-29FDA-DeviceAdept Medical LtdClass IIOtological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
Lack of 510(k) clearance.
- 2025-01-29FDA-DeviceAdept Medical LtdClass IIOtological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
Lack of 510(k) clearance.
- 2025-01-29FDA-DevicePercussionaire CorporationClass IVDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 Control Unit Tester -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON -PRT 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10 -PRT 993, VDR4 Humidification Kit with Cross Tee, Case of 10 The Phasitron breathing circuit kit is intended to be used for continuous ventilation intended for controlled ventilation of patients
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.
- 2025-01-29FDA-DeviceJinan Bodor Cnc Machine Co LtdClass IIBodor P and C series laser cutting machines
Non-compliant laser products
- 2025-01-22FDA-DeviceOlympus Corporation of the AmericasClass IILithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.
Potential for distal tip tearing of the Mechanical Lithotriptor V.
- 2025-01-22FDA-DeviceAccriva Diagnostics, Inc.Class IIVerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
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.
- 2025-01-22FDA-DeviceA L I Technologies LtdClass IIChange Healthcare Cardiology Hemodynamics software
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
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