Category
FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
Philips Ultrasound, Inc. is recalling Philips C9-5EC transducer devices that were refurbished beyond their useful life, which may affect device performance and safety.
Philips Ultrasound is recalling Philips S5-1 Transducers because they were refurbished beyond their useful life, which may affect device performance and safety.
Siemens Healthcare Diagnostics is recalling 3,266 units of ADVIA 120/2120/2120i 3-in-1 TESTpoint Control worldwide due to incorrect platelet value assignments that could affect test results.
Medline is recalling 36 Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN due to a potential needle retraction failure during insertion.
C.R. Bard Inc is recalling 63 units of the Bard Urologist's Tray due to cather packaging that may contain the incorrect French size, which could affect device use.
VITROS 4600 Chemistry Systems are being recalled because a software anomaly can allow results to be reported using diluent packs the system treats as expired, which can produce erroneous results.
Apex Knee System components are being recalled because the age of the nylon packaging material has caused a loss of integrity of some pouches. 341 units are affected.
Change Healthcare Cardiology Hemodynamics Software version 15.0.1 is being recalled because, following complaints, a software update may cause the software to unexpectedly shut down.
Medline RETINAL PACK-LF convenience kits are being recalled because the BD Insyte Autoguard catheter needle inside may be slow to retract or fail to retract during insertion. 80 units affected.
Becton, Dickinson and Company is recalling BD FACS 7-Color Setup Beads (REF 666289, Lots 85637 and 85638) because errors in the spectral overlap factors table may prevent accurate setup of flow cytometry instruments.
C.R. Bard Inc is recalling BD Heyman Follower Straight Tip catheters because packaging may contain an incorrect French size designation, which could lead to use of the wrong catheter size.
Philips Ultrasound is recalling 5,230 L8-4 transducer units that were refurbished beyond their useful life, which may affect device safety and performance. The units were distributed nationwide and internationally.
Geneoscopy, Inc. is recalling ColoSense Test Kit Part No. 80-001 (Lot 80-001-A2501) due to multiple plate failures caused by Low Positive Template Control being too high and out of range.
Philips Ultrasound is recalling Philips eL18-4 Transducers because they were refurbished beyond their useful life, which may affect device performance and patient safety.
Philips Ultrasound, Inc. is recalling Philips S7-2 Transducer ultrasound devices that were refurbished beyond their useful life. The affected devices have been distributed domestically and internationally.
Philips Ultrasound is recalling approximately 5,230 eL18-4 EMT ultrasound transducers that were refurbished beyond their useful life, which may affect device performance or safety.
C.R. Bard Inc is recalling certain BD Heyman Follower Coude Tip catheters because the packaging may display the incorrect French size, which could lead to use of the wrong size device.
Philips X5-1 Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
BD FACS 7-Color Setup Beads are being recalled because errors in the spectral overlap factors table may affect accurate setup of the flow cytometry instrument. 590 units affected.
Philips VL13-5 Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
VITROS Chemistry Products OP Reagent Gen 15 lots are being recalled because they may generate lower than expected quality control results. 2,017 units are affected.
ADVIA 120/2120/2120i 3-in-1 TESTpoint Control lots are being recalled because they have the incorrect platelet value assignments for ADVIA hematology systems. 4,214 units affected.
Philips L9-3 Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
An interventional fluoroscopic x-ray system is being recalled because a communication failure between the dose sensor and the software may cause the system to incorrectly report a high dose.
Philips X8-2t Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
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