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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 certain lots of Guider Softip Guide Catheters because they were manufactured with an incorrect tip curve shape that differs from the labeled specification.
Qiagen is recalling therascreen KRAS RGQ PCR Kits due to ambiguous handbook instructions that could lead to false negative results in cancer mutation detection. All kits with expiry dates of March 2023 or later are affected.
Real Intelligence CORI RI.KNEE v2.0 surgical planning software is being recalled due to a missing planning stage in cases with significant knee deformation. Affected units nationwide should not be used without verification.
Boston Scientific is recalling Guider Softip Guide Catheters from certain lots because the tip curve shape does not match the labeled specification. No illnesses or injuries have been reported.
AB Sciex is recalling three API3200MD mass spectrometers due to a rare risk of fire and electrode ejection from a solvent leak combined with electrical discharge. The flame could cause injury to users or property damage.
Boston Scientific is recalling 1,728 units of Guider Softip Guide Catheter 6F due to a manufacturing defect producing incorrect tip curve shapes differing from labeled specifications.
AB Sciex has recalled 38 units of the 4500MD Triple Quad Mass Spectrometer nationwide due to a rare risk of flame and electrode ejection from solvent leaks combined with electrical discharge.
The Puritan Bennett Cuff Pressure Manager's internal power inlet can become dislodged, preventing the device from charging. This may delay patient treatment.
A software defect in the Philips EarlyVue VS30 Vitals Monitor prevents alarms when respiration rate limits are violated, potentially delaying detection of dangerous breathing changes. Thirteen devices distributed in Massachusetts, Michigan, and Brazil are affected.
Certain lots of Guider Softip Guide Catheters were manufactured with an incorrect tip curve shape that differs from labeled specifications. The recalled devices include 17,436 units distributed in Indiana.
Ortho-Clinical Diagnostics is recalling 9,860 Proboscis/Piston Assemblies for VITROS diagnostic systems manufactured April-December 2022 due to a manufacturing defect that may cause falsely elevated drug assay results and delayed patient test results.
Olympus is recalling Veran endobronchial navigation systems due to manufacturing non-conformances and insufficient electromagnetic compatibility evidence. Devices may malfunction or interfere with other medical equipment.
Becton Dickinson is recalling BD Cathena IV catheters because the safety shield may fail to properly engage, potentially exposing the contaminated needle.
Boston Scientific is recalling Guider Softip Guide Catheters (Catalog M003101440) in certain lots due to incorrect tip curve shape that differs from the labeled specification. The recall affects 2,184 units.
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Iron_2 Reagents due to a potential positive bias in test results that could affect the accuracy of Quality Control and patient iron level measurements.
Getinge is recalling the Meera Mobile Operating Table due to unintended movement that could occur during surgery. 224 units nationwide are affected.
Philips is recalling the EarlyVue VS30 Vital Signs Monitor due to a software issue that prevents the device from alarming when a patient's respiration rate exceeds safe limits, potentially delaying critical clinical intervention.
Boston Scientific is recalling Guider Softip Guide Catheters because certain lots were distributed with an incorrect tip curve shape that differs from labeled specifications.
Olympus is recalling 522 units of Veran navigation system biopsy needles due to manufacturing defects and insufficient electromagnetic compatibility testing. Devices may not function properly in certain electromagnetic environments.
Siemens Medical Solutions is recalling over-ear headphones used with MAGNETOM MRI systems. Lubricating grease in the headband may cause visible imaging artifacts during head examinations.
Medtronic is recalling Restore Clinician Programmer Application Software due to compatibility issues with legacy software that prevent communication with implanted neurostimulators. The recall affects 2,408 devices worldwide.
Philips Respironics V60 and V60 Plus ventilators are recalled because their power management components may fail, causing complete loss of ventilator function. The FDA classified this as a Class I recall.
J&T Health and Wellness LLC recalls the ProSun Luxura Vegaz Model 52X ultraviolet tanning device due to a potential safety circuit defect. A communication isolator may cause a disturbance that compromises the safety circuit.
3M is recalling 79,500 Attest Super Rapid Readout Biological Indicators because the cap may melt, deform, or crack during steam sterilization cycles, potentially compromising sterilization validation.
Wolf, Henke Sass is recalling Henke-Ject-2 single-use sterile syringes due to potential damage to the sterile barrier that could compromise product sterility. Approximately 216,000 units are affected across the US and Canada.
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