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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.
BD Insyte Autoguard BC IV catheters may have needles that fail to retract properly, potentially causing contaminated needlestick injuries, blood leakage, and repeated insertion attempts.
24 Olympus EVIS EXERA III colonoscopes distributed to six states are recalled due to improperly repaired connectors that may cause image loss, decreased suction, or improper reprocessing, potentially exposing patients to contaminated equipment.
PATH's SENTIERO SCREENING hearing examination devices (Model SOH100098) are being recalled due to technical distortions that may exceed expected levels. The recall affects devices distributed in Florida, Missouri, Ohio, and Wisconsin.
Abbott is recalling specific lots of the Alinity m HCV AMP Kit due to reports of false positive results and reactive negative controls. The kit detects hepatitis C virus in blood samples.
Siemens RAPIDPOINT 500e blood gas systems may show falsely elevated sodium readings in patients taking Perhexiline Maleate or Atomoxetine, risking misdiagnosis and inappropriate treatment of electrolyte imbalances.
Aizu Olympus gastrointestinal videoscopes (GIF-H190) may have defective repairs that prevent proper sterilization, risking patient exposure to contaminated material. Affected units were distributed to medical facilities in six states.
Medtronic recalled 64,739 ICM LNQ22 LINQ II insertable cardiac monitors due to potential amplified noise or signal reduction that may interfere with heart rhythm recordings.
Aizu Olympus is recalling 24 colonoscopes with defective repairs to the light guide connector. The defect may prevent proper imaging, reduce suction, and impair device cleaning, potentially exposing patients to contamination.
PATH recalls SENTIERO hearing examination devices for excessive technical distortions. Affected units are distributed in FL, MO, OH, and WI.
Edwards Lifesciences is recalling 1417 FloTrac Sensors used for intravascular pressure monitoring due to potential flushing difficulties during kit setup. No illnesses or injuries have been reported.
Edwards Lifesciences is recalling Acumen IQ intravascular pressure monitoring sensors (6,714 units) due to potential flushing difficulties during setup of the pressure monitoring kit.
EMD Millipore's Lugol's Iodine Solution (Lot 3124) is recalled due to an improper seal between the cap and bottle, which allows iodine vapors to dissipate and reduces the product's potency over time.
Edwards Lifesciences' FloTrac Sensor with Vamp System is being recalled due to potential flushing difficulties during setup of the pressure monitoring kit. No injuries have been reported.
PATH is recalling AuDX PRO hearing examination devices because they may produce technical distortions greater than expected, which could affect diagnostic accuracy. The recall affects 23 units distributed in Florida, Missouri, Ohio, and Wisconsin.
Edwards Lifesciences is recalling 118,570 units of the TruWave Pressure Monitoring Set due to potential flushing difficulties during setup. The device is used for hemodynamic pressure monitoring.
Unomedical recalls 3,362 units of VariSoft infusion sets due to connector damage causing premature disconnection and missed insulin doses, risking dangerous elevation of blood glucose and ketone levels.
The FDA recalls 1,679 VariSoft infusion sets (Model 1002828) due to connector damage that causes improper detachment. Undetected disconnections can lead to missed insulin doses and diabetic ketoacidosis.
Unomedical is recalling 8,028 VariSoft infusion sets due to a manufacturing defect that makes the connector prone to unintended disconnection, potentially leading to missed insulin doses and serious blood glucose complications.
Certain BD Extension Sets sold as free of DEHP (di(2-ethylhexyl) phthalate) actually contain this restricted phthalate. The products have been distributed worldwide.
Convergent Dental is recalling 39 Solea laser surgical instruments due to potential unintended laser activation without foot pedal depression. No injuries have been reported.
SunMed Holdings recalls Ventlab STAT-Check manual resuscitators due to a backwards leak in the integrated manometer allowing CO2 rebreathing, which may impair ventilation. Multiple models (Adult, Infant, Pediatric) are affected and distributed nationwide.
Aizu Olympus is recalling cystonephroscope endoscopes due to an unvalidated air drying process that allowed water to remain in instrument channels. Retained moisture poses a risk of contamination and infection.
Aizu Olympus is recalling 61 tracheal videoscopes (Model LF-V) due to an unvalidated air drying process that left water in channels after repair. Water in the endoscope channels may become contaminated and pose an infection risk.
Aizu Olympus is recalling 3,627 gastrointestinal videoscopes because the channel air drying process was not validated. A small percentage of devices returned after repair had wet channels, creating potential for contamination and risk of infection.
Aizu Olympus is recalling 1577 ureteralscope units due to an unvalidated channel air drying process that left some units with residual water after repair, creating a contamination and infection risk.
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