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.
Becton Dickinson is recalling BD Vacutainer PST Gel and Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.
Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.
Becton Dickinson is recalling BD Max Enteric Viral Panel EU kits because foil bags containing extraction tubes may not have been sealed properly.
Pro-Dex Inc is recalling sterile surgical driver battery packs due to visual particulates found within the Tyvek pouches.
Becton Dickinson is recalling BD Max MRSA XT kits because foil bags containing extraction tubes may not have been sealed properly.
Becton Dickinson is recalling BD MAX Reagent extraction tube kits because foil bags may not be sealed properly.
Becton Dickinson is recalling BD Max Enteric Parasite Panel EU kits because foil bags containing extraction tubes may not be sealed properly.
Becton Dickinson is recalling BD Max StaphSR kits because foil bags containing extraction tubes may not have been sealed properly.
Siemens Medical Solutions USA is recalling 143 MAGNETOM Aera MRI devices due to a potential open port in the quench venting system when using the optional horizontal outlet.
Becton Dickinson is recalling 715 units of the Kit EXT Enteric Bacterial Panel because foil bags containing extraction tubes may not have been sealed properly.
Becton Dickinson is recalling BD Max ExK TNA 2 kits because foil bags containing extraction tubes may not have been sealed properly.
Becton Dickinson is recalling 115 units of BD Max ExK DNA 1 USA kits because foil bags containing extraction tubes may not be sealed properly.
Becton Dickinson is recalling BD MAX Reagent extraction tubes because foil bags may not be sealed properly, potentially compromising product integrity.
Cambridge Sensors Limited is recalling Microdot Xtra blood glucose test strips in Illinois because faulty manufacturing equipment prevented the strips from fitting into the meter.
Becton Dickinson is recalling 176 units of BD MAX MRSA Reagent Kits because foil bags containing extraction tubes may not have been sealed properly.
Aniara Diagnostica LLC is recalling 46 units of ZYMUTEST HIA MonoStrip ELISA kits due to residual crystallization and out-of-range negative controls.
Becton Dickinson is recalling BD Max StaphSR kits because foil bags containing extraction tubes may not be sealed properly.
Becton Dickinson is recalling BD MAX Reagent extraction tubes because foil bags may not be sealed properly, potentially compromising product integrity.
Becton Dickinson is recalling BD MAX Enteric Bacterial Panel kits because foil bags containing extraction tubes may not have been sealed properly.
Becton Dickinson is recalling BD MAX Cdiff EU reagent kits because foil bags containing extraction tubes may not have been sealed properly.
Becton Dickinson is recalling 27 units of BD Max Enteric Viral Panel RUO kits because foil bags containing extraction tubes may not have been sealed properly.
Becton Dickinson is recalling 666 BD Max Vaginal Panel kits because foil bags containing extraction tubes may not be sealed properly.
Aniara Diagnostica LLC is recalling 51 units of the ZYMUTEST HIA MonoStrip IgG ELISA kit due to residual crystallization and out-of-range negative controls.
Becton Dickinson is recalling BD Max GC RT PCR Assay kits because foil bags containing extraction tubes may not be sealed properly.
Becton Dickinson is recalling 130 units of BD Max Check-Points CPO IVD kits because foil bags containing extraction tubes may not be sealed properly.
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