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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.
Medtronic is recalling IN.PACT AV paclitaxel-coated balloon catheters because packaging damage may result in loss of sterility. The devices were distributed worldwide and in the United States.
American Contract Systems is recalling ACS Arthroscopy, Knee, and Hand surgical kits because they were sterilized using a higher than specification ethylene oxide concentration.
Instrumentation Laboratory is recalling HemosIL ReadiPlasTin due to variable and out-of-specification quality control results. The manufacturer is removing all affected lots and providing customers with an alternative reagent.
Karl Storz cystoscopes manufactured since January 2018 are recalled because they may not achieve required disinfection levels. Inadequate disinfection could lead to patient infection during urological procedures.
Simplivia Healthcare is recalling OnGuard2 CSTD Bag Adaptors because they may disconnect from infusion bags, potentially spilling hazardous medications.
Shanghai United Imaging's digital X-ray systems may display reversed spine positioning labels, potentially causing misdiagnosis and unnecessary repeat radiation exposure for patients.
Karl Storz ureteroscopes and flexible video ureteroscopes may fail to achieve adequate sterilization during the disinfection process, potentially leaving microorganisms on the devices that could cause patient infections.
Daavlin is recalling 1 Series CX phototherapy units due to a software bug that swaps calibration distance settings when resuming interrupted treatments, resulting in incorrect dosing.
American Contract Systems recalls ACS Lap Chole Pack surgical kits due to sterilization with ethylene oxide concentration exceeding manufacturer specification.
Karl Storz is recalling multiple Flexible Video Urethro Cystoscope models because they may fail to achieve proper disinfection between procedures, posing a risk of microbial contamination.
Karl Storz Endoscopy is recalling flexible ureteroscopes manufactured or distributed since January 2018 due to the disinfection process failing to achieve expected microbial reduction levels.
Karl Storz Endoscopy is recalling CMOS Video Cysto-Urethroscope devices because they fail to achieve adequate microbial reduction during disinfection, creating infection risk.
Olympus is issuing updated instructions for reprocessing its EVIS EXERA bronchovideoscopes to ensure proper sterilization and disinfection procedures. Improper reprocessing could compromise device safety.
Karl Storz Endoscopy is recalling Flexible Video-Uretero-Renoscope instruments due to inadequate microbial disinfection. All units manufactured since January 2018 are affected.
Karl Storz Endoscopy is recalling Flexible Video Cysto-Urethroscopes due to a disinfection process failure that may not adequately eliminate microorganisms. Affected units have been distributed nationwide and internationally since January 2018.
The Philips Hemodynamic Application, Model 722463, may not automatically switch to neonatal mode for blood pressure monitoring, potentially applying excessive cuff pressure that could cause bruising, nerve damage, or bone deformity in newborns.
The FDA is recalling KARL STORZ Slim Nasopharyngolaryngoscope models 11001RD1 and 11001RDK1 because they fail to achieve adequate disinfection, potentially allowing microorganisms to persist on the device and transmit between patients.
Synthes has updated safety instructions for its Radial Head Replacement System implant with absolute contraindications for use in patients with infection, sepsis, or osteomyelitis. The FDA has classified this as a Class II recall.
Karl Storz is recalling HD-VIEW Flexible HD Cysto-Urethroscope models that fail to adequately disinfect during processing, creating a potential infection risk. All units manufactured since January 2018 are affected.
Microtek Medical Inc. is recalling TMJ Arthroscopy Drapes that contain latex but were mislabeled as latex-free, posing an allergic reaction risk to patients and healthcare workers with latex sensitivities.
Karl Storz is recalling flexible bronchoscopes due to potential failure of the disinfection process. The devices may not eliminate microorganisms adequately, posing an infection risk to patients.
Karl Storz Endoscopy is recalling Flexible Video-Uretero-Renoscope (FLEX-XC) models because they may fail to achieve adequate disinfection, creating potential microbial contamination risk.
Karl Storz Flexible Cystoscope units may not be properly disinfected because the disinfection process fails to achieve the expected reduction of microorganisms. All units manufactured since January 2018 are potentially affected.
American Contract Systems is recalling ACS Spine Pack and ACS Lumbar/Back Set Up Tray surgical instrument sets due to improper sterilization with excess ethylene oxide. The affected sets were distributed in Illinois, Missouri, Nebraska, and Texas.
Certified Safety Mfg Inc is recalling first aid kits and cabinets containing Medi-First medication components due to manufacturing practice deviations at the component supplier.
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