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.
Shimadzu Medical Systems is recalling its Digital Radiography X-Ray System because a report was received regarding lost images under certain circumstances.
Bio-Rad is recalling Variant II beta-thalassemia Short Program kits because buffer issues may cause calibration and quality control failures.
Stryker Endoscopy is recalling 2,591 12-Instrument Sterilization Trays because gravity sterilization parameters in the reprocessing guide did not fully consider all worst-case scenarios during validation testing.
Tenex Health Inc is recalling TX1 Tissue Removal Systems because cracks in the packaging may compromise the sterile barrier during transport in extreme cold.
Alere San Diego, Inc. is recalling specific lots of the Alere Triage BNP Test because they may not recover within range when tested with certain controls.
Siemens Healthcare Diagnostics Inc is recalling CLINITEK Status+ Analyzers with Sample Interference Notes enabled because they were not cleared for US marketing.
Brainlab AG is recalling ExacTrac 6.0 systems because they may position patients to unintended radiation targets, potentially delivering dose to the wrong location.
Hospira is recalling 13,218 Abbott Acclaim Infusion Pumps because broken door assemblies may prevent the door from closing, potentially causing unrestricted flow or therapy delays.
Hospira is recalling 13,218 Acclaim Encore infusion pumps because broken door assemblies may prevent proper closure, causing unrestricted flow or therapy delays.
Hospira is recalling GemStar Docking Stations because they may cause infusion pumps to fail to power up or stop infusions due to voltage errors.
Acumed LLC is recalling the Osteo-Clage System because the stainless steel used in manufacturing was not within specifications.
GE Healthcare is recalling 1,548 MRI scanners because a malfunctioning cradle release mechanism could delay or impede patient egress from the system.
Philips Medical Systems is recalling 1,043 ADAC nuclear gamma cameras because a belt slippage issue could cause the detector head to drift and contact patients.
GE Healthcare is recalling CardiacVX and CardiacVX Flow software because it may report flow values higher than actual. The recall affects 101 units distributed worldwide.
Fisher Scientific is recalling Fisherbrand Sterile Swabs after a customer reported the presence of an organism in a lot of wood applicator swabs.
Acumed LLC is recalling specific lots of Tension Band Pins because they were manufactured with stainless steel that does not meet specifications.
Alfa Wassermann is recalling specific lots of ACE AST Reagent because they produce extremely low absorbance readings, which may affect clinical test results.
Ortho-Clinical Diagnostics is recalling VITROS Specialty Diluent because it may cause C-Reactive Protein test results to be approximately 51% lower than expected.
Siemens Healthcare Diagnostics is recalling IMMULITE Total IgE assays due to a confirmed 23% positive bias against the WHO 2nd IRP 75/502.
Siemens recalls IMMULITE Androstenedione assays because they over-recover samples above 5.5 ng/mL, contradicting the stated 10 ng/mL linearity limit.
Alfa Wassermann is recalling 731 kits of ACE ALT Reagent due to extremely low absorbance readings that may affect test accuracy.
Siemens recalls Androstenedione assays because they over-recover samples above 5.5 ng/mL, contradicting the stated 10 ng/mL limit.
Medtronic is recalling external neurostimulators because current labeling indicates the cycling feature improves device longevity and recharge interval.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products FS Diluent Pack 3 because internal testing found it may cause C-Reactive Protein test results to be approximately 51% lower than expected when used for dilution.
Teleflex Medical is recalling 7,380 units of Dekna-lok sutures because they did not meet minimum resorption strength requirements. The affected products were distributed in the US, Ireland, and Singapore.
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