February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DC
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, C
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Ca
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FA
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRES
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTO
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog N
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to a qualified and authorized he
Hazard: Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
February 19, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and aut
Hazard: Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
February 19, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medications to a qualified and autho
Hazard: Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
February 19, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense medications to a qualified and
Hazard: Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
February 19, 2025Medical DevicesFDA
MICROVENTION INC. recalls MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297
Hazard: Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
February 19, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedSta
Hazard: Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.
February 19, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES
Hazard: Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues
February 19, 2025Medical DevicesFDA
Max Mobility LLC recalls Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Whee
Hazard: Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.
February 19, 2025Medical DevicesFDA
Max Mobility LLC recalls Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheel
Hazard: Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.
February 19, 2025Medical DevicesFDA
Ithera Medical Gmbh recalls The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered com
Hazard: The MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. The previous version of the user manuals contained a wrong value for the Nominal Ocular Hazard Distance (NOHD).
February 19, 2025Medical DevicesFDA
Getinge Usa Sales Inc recalls Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Fl
Hazard: Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia.
February 19, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide S
Hazard: Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
February 12, 2025Medical DevicesFDA
Medicrea International recalls UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-b
Hazard: Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes the following: Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification.
February 12, 2025Medical DevicesFDA
Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Hazard: A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.
February 12, 2025Medical DevicesFDA
US Endodontics, LLC recalls Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP12525
Hazard: Due to devices being irradiated above the established specification which my result in package integrity issues.
February 12, 2025Medical DevicesFDA
Sysmex America, Inc. recalls Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for a
Hazard: Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.
February 12, 2025Medical DevicesFDA
Beckman Coulter Inc. recalls Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
Hazard: Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results may be delayed due to the time required to achieve a passing calibration curve.
February 12, 2025Medical DevicesFDA
DDS Lab recalls Temporary Titanium Abutments
Hazard: Certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the titanium abutment fracture, which may risk loosening of the affixed restoration; fragments could also injure oral mucosa, and could be aspirated.