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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.
Ad-Tech Lightweight CABRIO Cables with incorrect labels are being recalled. Mislabeling could cause product misidentification affecting proper use in clinical monitoring applications.
C.R. Bard is recalling 5,950 SureStep Foley Tray kits nationwide due to potential packaging defects that may impact the sterile barrier.
C.R. Bard is recalling 2,660 units of SureStep Foley Catheter Trays nationwide due to potential packaging defects that may impact the sterile barrier.
Aesculap Implant Systems is recalling Univation X System knee implant devices because they may loosen, potentially requiring revision surgery. All lots distributed in the US are affected.
GE Healthcare's Centricity PACS-IW system experiences image acquisition and synchronization failures that could impair the display of medical images. The software malfunction affects 392 devices globally.
Argon Medical Devices is recalling the Scorpion Portal Vein Access Set due to design changes that have caused the sheaths to crack or break at the tips. The affected product was distributed in the United States.
C.R. Bard Inc is recalling SureStep Foley Trays (Catalog A902616) due to packaging defects that may compromise the sterile barrier. Affected units were distributed nationwide.
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.
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 Inc is recalling Foley catheter care kits (catalog A303416A) because potential packaging defects could compromise the sterile barrier. Approximately 6,440 units were distributed nationwide.
C.R. Bard is recalling Foley catheter kits due to packaging defects that may compromise the sterile barrier. No illnesses have been reported.
Aesculap Implant Systems is recalling Univation X System knee implants nationwide due to potential loosening that may require revision surgery.
Aesculap Implant Systems is recalling Univation X System knee implants because they may loosen, potentially requiring additional surgery. The recall affects devices distributed nationwide.
Olympus is recalling the EVIS EXERA BF-XT160 bronchofibervideoscope due to a missing gluing step in manufacturing. The affected devices may develop leaks in the insertion tube, posing an infection control risk.
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.
Roche Molecular Systems is recalling cobas SARS-CoV-2 & Influenza A/B test kits following reports of increased false positive SARS-CoV-2 results.
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 Inc is recalling a Foley catheter tray due to potential packaging defects that may compromise the sterile barrier. Approximately 1,710 units were distributed nationwide.
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.
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 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 Inc is recalling SureStep Foley Catheter Trays due to potential packaging defects that may compromise the sterile barrier. The affected lot includes 1140 units distributed nationwide.
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.
C.R. Bard Inc is recalling approximately 4830 SureStep Foley catheter trays due to potential packaging defects that could compromise the sterile barrier.
C.R. Bard is recalling 11,780 Foley Tray units nationwide due to potential packaging defects that may compromise the sterile barrier.
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