April 23, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system
Hazard: The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
April 23, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H
Hazard: The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
April 23, 2025Medical DevicesFDA
Philips North America Llc recalls Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
Hazard: Potential for collimator to fall as a result of incorrect installation.
April 23, 2025Medical DevicesFDA
Philips North America Llc recalls Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
Hazard: Potential for collimator to fall as a result of incorrect installation.
April 23, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK
Hazard: If "Clear All" selected medications is selected on patient profile, the automated dispensing cabinet may allow dispensing of medication without first requiring the RxVerify Validation Code be entered/without validation from a pharmacist, which could lead to unintended and incorrect medication removal.
April 23, 2025Medical DevicesFDA
ZOLL Circulation, Inc. recalls Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (C
Hazard: AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.
April 23, 2025Medical DevicesFDA
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Pr
Hazard: Lack of sterility assurance for closed suction catheter systems
April 23, 2025Medical DevicesFDA
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product
Hazard: Lack of sterility assurance for closed suction catheter systems
April 23, 2025Medical DevicesFDA
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Pro
Hazard: Lack of sterility assurance for closed suction catheter systems
April 23, 2025Medical DevicesFDA
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Produc
Hazard: Lack of sterility assurance for closed suction catheter systems
April 23, 2025Medical DevicesFDA
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Produc
Hazard: Lack of sterility assurance for closed suction catheter systems
April 23, 2025Medical DevicesFDA
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product
Hazard: Lack of sterility assurance for closed suction catheter systems
April 23, 2025Medical DevicesFDA
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product D
Hazard: Lack of sterility assurance for closed suction catheter systems
April 23, 2025Medical DevicesFDA
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product D
Hazard: Lack of sterility assurance for closed suction catheter systems
April 23, 2025Medical DevicesFDA
Tandem Diabetes Care, Inc. recalls Tandem Mobi Insulin Pump with Interoperable Technology
Hazard: A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.
April 23, 2025Medical DevicesFDA
Tandem Diabetes Care, Inc. recalls t:slim X2 Insulin Pump with Interoperable Technology
Hazard: A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.
April 23, 2025Medical DevicesFDA
Bard Access Systems, Inc. recalls BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118
Hazard: Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.
April 16, 2025Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
Hazard: Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
April 16, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01
Hazard: Due to a software issue, when attempting to restock the automated dispensing cabinet, user have received the banner message "Stocking window has passed, or item has been removed from purchase order. Please contact Pharmacy for assistance". When this occurs, the medication cannot be restocked and can potentially lead to delays in accessing medication for patients.
April 16, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R
Hazard: Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
April 16, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R
Hazard: Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
April 16, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R
Hazard: Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
April 16, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated Cable, Item Number REF EICA5
Hazard: Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
April 16, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispen
Hazard: Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity to be recorded. This bug can also result in the CUBIE opening more times than needed for the transaction to be completed, which may result in a patient receiving more than the intended dose of medication.
April 16, 2025Medical DevicesFDA
Agilent Technologies, Inc. recalls GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit
Hazard: DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, Human Reference DNA Female aliquot, affected by a mosaic aberration that may result in Chromosome 12 baseline shift, which may lead to false positive/negative results, resulting in diagnosis delay, and may lead to delayed treatment of a treatable genetic disorder.
April 16, 2025Medical DevicesFDA
Medtronic Neuromodulation recalls Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis P
Hazard: There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
April 16, 2025Medical DevicesFDA
Tornier S.A.S. recalls stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty
Hazard: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
April 16, 2025Medical DevicesFDA
Tornier S.A.S. recalls stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Hazard: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
April 16, 2025Medical DevicesFDA
Tornier S.A.S. recalls stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty
Hazard: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
April 16, 2025Medical DevicesFDA
Tornier S.A.S. recalls stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Ins
Hazard: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.