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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.
UIH Technologies is recalling 95 uMI 550 PET/CT systems because third-party outer covers can become trapped between the patient table and gantry.
Home Health US is recalling 4,661 One Step Sterile Lancets because of incorrect or missing Unique Device Identifier codes.
Olympus is recalling EVIS EXERA III Bronchovideoscope BF-P190 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type Q180-AC units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Boston Scientific is recalling 3,592 PROPONENT DR EL 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.
Boston Scientific is recalling 12,326 VISIONIST 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 4,055 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.
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.
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.
Olympus is recalling Bronchofiberscope BF Type PE2 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
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 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.
Olympus is recalling Bronchovideoscope BF-XT190 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Boston Scientific is recalling 190,088 ESSENTIO DR EL 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 106,536 PROPONENT DR SL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Olympus is recalling Bronchovideoscope BF-1TQ170 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Olympus is recalling Bronchovideoscope BF Type 1T150 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Abbott is recalling 407 TactiFlex Sensor Enabled Ablation Catheters in the UniD curve D configuration after becoming aware of tip detachment events during removal from the packaging.
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 Bronchovideoscope BF-H1100 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
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.
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 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.
Cook Medical is recalling 695 Zenith Alpha 2 Thoracic Endovascular Grafts because affected devices may contain PTFE coating scrapings that could be released during deployment.
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