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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.
Boston Scientific is recalling 32,695 ACCOLADE DR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 16,077 ACCOLADE SR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Olympus is recalling OES Bronchofiberscope BF Type P60 units for additional instructions-for-use updates clarifying safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling EVIS EXERA III Bronchovideoscope BF-Q190 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Boston Scientific is recalling 4,055 ALTRUA 2 DR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Olympus is recalling EVIS EXERA Bronchovideoscope BF Type XT160 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Boston Scientific is recalling 22,714 ESSENTIO DR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 1,050 VISIONIST CRT-P EL devices under model U226, part of a software update designed to prevent Safety Mode starting outside hospital.
Boston Scientific is recalling 1,380 PROPONENT SR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Olympus is recalling EVIS EXERA III Bronchovideoscope BF-H190 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Percussionaire is recalling 59,160 Phasitron 5 IPV in-line valves whose pressure relief seal may leak when used with a ventilator, and is warning against use in neonates and infants.
Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type 1T180 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling Bronchofiberscope BF Type TE2 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling EVIS EXERA III Bronchovideoscope BF-1TH190 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Boston Scientific is recalling 10,833 ESSENTIO DR EL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 3,620 VALITUDE CRT-P EL devices, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 4,827 ESSENTIO SR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 50,135 ACCOLADE SR SL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 2,426 PROPONENT DR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Olympus is recalling OES Bronchofiberscope BF Type XT40 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling Bronchovideoscope BF-1TH1100 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Boston Scientific is recalling 223,163 ESSENTIO DR SL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 90,931 ACCOLADE DR SL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 41,009 PROPONENT SR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type 1TQ180 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
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