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.
M.D.L. S.r.l. is recalling 2,750 Aspirated Cyto-Histological Biopsy needles nationwide due to compromised sterility assurance. Affected healthcare providers and patients should consult their healthcare provider for guidance.
C.R. Bard is recalling 420 units of Foley catheter care trays nationwide due to potential packaging defects that may impact the sterile barrier.
Philips Ultrasound is recalling Affiniti diagnostic ultrasound systems due to a software defect that intermittently causes device lock-ups when exiting Review Mode during patient exams. No illnesses or injuries have been reported.
Aesculap is recalling Univation X System Tray knee implants due to a loosening defect that may require revision surgery. All lots nationwide are affected.
Paragon 28 is recalling Phantom Nail System surgical drills due to a thin wall condition between the cannulation and flutes. This defect could potentially cause the drill to fracture during use.
Aesculap Implant Systems is recalling Univation X System knee implant devices nationwide due to potential loosening. The malfunction could require revision surgery.
C.R. Bard Inc is recalling approximately 29,890 units of Foley catheter trays due to potential packaging defects that may compromise the sterile barrier. No illnesses or injuries have been reported.
Medtronic is recalling 51,494 DLP Left Heart Vent Catheters due to potential wire protrusion through the catheter tip. This defect could compromise proper device function during use.
M.D.L. S.r.l. is recalling approximately 4,120 units of general manual surgical instruments nationwide due to compromised sterility assurance. Healthcare facilities should verify lot numbers and quarantine affected instruments immediately.
C.R. Bard is recalling 3,980 units of Foley catheter supply kits due to potential packaging defects that may compromise the sterile barrier. No illnesses have been reported.
M.D.L. S.r.l. has recalled approximately 20,129 soft tissue biopsy needles nationwide because sterility assurance may be compromised.
C.R. Bard is recalling a Foley catheter tray system due to packaging defects that may compromise the sterile barrier. The recall affects 8,170 units distributed nationwide.
Aesculap is recalling Univation X System knee implants nationwide because they may loosen, potentially requiring revision surgery.
C.R. Bard Inc is recalling a Foley catheter tray system due to potential packaging defects that may compromise the sterile barrier, affecting 1,760 units distributed nationwide.
C.R. Bard is recalling 960 units of Foley Tray catheter kits (lot NGFR0101) due to potential packaging defects that may compromise the sterile barrier.
In2bones USA is recalling CoLink Bone Graft Harvesters after reports of the instruments breaking at the outer tube weld site. The recall affects 835 units distributed nationwide across 29 states.
C.R. Bard is recalling 11,780 Foley Tray units nationwide due to potential packaging defects that may compromise the sterile barrier.
M.D.L. S.r.l. is recalling 320 units of Mammary Nodules Localization devices distributed nationwide due to potential compromise of sterility assurance.
GE Healthcare is recalling Centricity Universal Viewer and Viewer 6.0 software due to image acquisition and synchronization failures with the Centricity Enterprise Archive that could impact diagnostic data integrity.
Medtronic recalls DLP Left Heart Vent Catheters due to risk of wire protrusion through the catheter tip. The defect could cause internal injury during cardiac procedures.
C.R. Bard is recalling Foley catheter kits due to packaging defects that may compromise the sterile barrier. No illnesses have been reported.
C.R. Bard Inc is recalling Foley Tray kits nationwide due to potential packaging defects that may compromise the sterile barrier. The product was distributed throughout the United States.
Beckman Coulter is recalling Access SARS-CoV-2 IgG test kits nationwide due to insufficient evidence in the FDA authorization submission. The test validation may be inadequate for accurate COVID-19 antibody detection.
M.D.L. S.r.l. is recalling approximately 21,518 bone marrow biopsy needles distributed nationwide because sterility assurance may be compromised.
C.R. Bard is recalling 18,060 units of SureStep Foley Catheter Trays due to potential packaging defects that may compromise the sterile barrier. No illnesses or injuries have been reported.
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