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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.
Biopsybell S.R.L. is recalling 5 units of the BPB medica CEMIX cement mixing system because products labeled as sterile may not have been sterilized.
Biopsybell is recalling 8G Direct Working Cannula Bevel Tips labeled as sterile that may not have been sterilized. The recall affects 30 units distributed in Mississippi and Kentucky.
Boston Scientific is recalling VICI RDS Venous Stent Systems manufactured between May 2018 and April 2021 due to reports of stent migration after implantation.
Biopsybell S.R.L. is recalling 500 units of the Cement Mixing System, Vertebroplasty-Kyphoplasty, Ref VCF-1051, because products labeled as sterile may not have been sterilized.
BPB medica is recalling 10 units of RENOVA SPINE kyphoplasty cannulas labeled as sterile but potentially not sterilized. The recall covers distribution in Mississippi and Kentucky.
Biopsybell S.R.L. is recalling 75 units of 10 Gauge Drills labeled as sterile that may not have been sterilized.
Biopsybell S.R.L. is recalling CEMIX Cement Mixing Systems labeled as sterile because they may not have been sterilized.
Bard Access Systems is recalling Groshong NXT ClearVue Catheters due to defects in the distal connector that may prevent proper catheter passage or locking.
Medtronic is recalling Guardian Sensor 3 units worldwide because use with hydroxyurea may cause inaccurate glucose readings.
Bard Access Systems is recalling specific lots of Groshong NXT ClearVue Catheters because connector defects may prevent proper catheter passage or locking.
Medtronic is recalling Guardian Sensor 3 kits because use with the drug hydroxyurea may cause inaccurate, elevated glucose readings.
RaySearch Laboratories is recalling RayStation software because the total dose display may be incorrect when using multiple plans in a treatment course.
BPB medica is recalling Osteobell Explant Needles because they were labeled as sterile but may not have been sterilized.
Bard Access Systems is recalling specific lots of Groshong NXT ClearVue Catheters because connector defects may prevent proper catheter passage or locking.
Bard Access Systems is recalling specific replacement connectors for Groshong NXT PICC catheters due to manufacturing defects that may prevent proper catheter passage or locking.
Bard Access Systems is recalling specific Groshong NXT ClearVue Catheter Basic Kits because the distal connector may be defective, preventing proper catheter passage or locking.
Bard Access Systems is recalling specific Groshong NXT ClearVue catheters because connector defects may prevent proper catheter passage or locking.
Bard Access Systems is recalling Groshong NXT ClearVue Catheters because connector defects may prevent proper catheter passage or locking.
Biopsybell S.R.L. is recalling 60 units of Renova Spine Bone Filler labeled as sterile but potentially not sterilized. The product was distributed in Mississippi and Kentucky.
Biopsybell S.R.L. is recalling 8G Direct Working Cannula Bevel Tips labeled as sterile but potentially not sterilized. The recall affects 30 units distributed in Mississippi and Kentucky.
Medtronic is recalling Guardian Sensor 3 units because use with hydroxyurea may cause inaccurate glucose readings.
Medtronic is recalling Enlite Glucose Sensors because use with hydroxyurea may cause inaccurate elevated readings.
Bard Access Systems is recalling specific lots of Groshong NXT ClearVue Catheters because connector defects may prevent proper catheter passage or locking.
Medtronic is recalling Enlite Glucose Sensors because use with hydroxyurea may cause inaccurate elevated readings.
Medtronic is recalling Guardian Sensor 3 units because use with the drug hydroxyurea can cause inaccurate elevated glucose readings.
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