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.
PTW Freiburg is recalling VERIQA RT MonteCarlo 3D software because it fails to clearly display bolus inclusion during secondary dose calculation, which may lead to incorrect dose delivery.
Abiomed is recalling 5,232 Automated Impella Controllers because a purge flag component may fail, causing recognition issues.
AVID Medical is recalling 1,640 Haylard 18G Single Shot Epi Trays because they contain Sodium Chloride ampules subject to a separate recall for potential quality and sterility issues.
AVID Medical is recalling Haylard Basic Biopsy Trays because they contain Sodium Chloride ampules subject to a separate recall for quality and sterility issues.
Nova Biomedical is recalling StatStrip Glucose Hospital Meter Systems due to a software defect that can cause patient glucose results to be assigned to the wrong medical record.
Medline is recalling specific lots of Anesthesia L&D A-Line Sets due to potential Aspergillus penicillioides contamination in sterile applicators.
Nova Biomedical is recalling StatStrip Glucose and B-Ketone meters because a software defect may cause patient data to be assigned to the wrong medical record.
Howmedica Osteonics Corp. is recalling specific orthopaedic implant components made with aged UHMWPE material. The material may oxidize, leading to increased wear and potential device failure.
GE Medical Systems is recalling Carescape Central Station units that may not resume patient monitoring for three minutes after a system restart.
Pi-Cardia is recalling 46 ShortCut transfemoral catheters because the positioning arm may detach due to a weld issue.
Bard Access Systems is recalling 22,980 DuoGlide and Niagara short-term dialysis catheters nationwide as a downstream action to a Class I recall.
Howmedica Osteonics Corp. is recalling OMNIFIT Series I acetabular inserts because aged polyethylene material may cause excessive wear and device failure.
BD Switzerland is recalling BD Alaris Pump Infusion Sets due to discrepancies in performance data that may lead to inappropriate pump performance.
Howmedica is recalling specific Scorpio patella implants because aged polyethylene material may cause excessive wear, leading to device failure and potential revision surgery.
Medline Industries is recalling 447 convenience kits nationwide due to potential fungal contamination that could cause serious health consequences.
Abiomed is recalling Impella Optical Controllers because a purge flag component may fail, causing recognition issues. The recall covers 4,100 units distributed in the US and internationally.
AVID Medical is recalling 340 biopsy kits because they contain sodium chloride ampules subject to a separate recall for quality and sterility issues.
Howmedica is recalling 12,156 orthopaedic implant components made with aged polyethylene material. The aging may cause excessive wear, leading to device failure and potential need for revision surgery.
Howmedica Osteonics Corp. is recalling Trident polyethylene knee inserts because aged raw material may cause excessive wear and device failure.
Medline is recalling 10,407 convenience kits containing sterile applicators that may be contaminated with Aspergillus penicillioides, posing a risk of serious infection.
AVID Medical is recalling 80 Haylard Continuous Nerve Block Kits due to potential sterility issues in included Sodium Chloride ampules.
AVID Medical is recalling Halyard IV Start Kits because they contain applicators contaminated with Aspergillus penicillioides.
Nova Biomedical is recalling StatStrip Glucose meters due to a software defect that may assign patient test results to the wrong medical record.
Abiomed is recalling 1,422 Impella Optical Controllers because a purge flag component may fail, causing purge cassette recognition issues.
Bard Access Systems is recalling Power-Trialysis dialysis catheters as a downstream action to a Class I recall.
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