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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.
Exactech is recalling certain Optetrak Logic PS Knee Systems due to potential loss of vacuum in the inner-most vacuum bag. The company has received 3 complaints involving 4 devices.
Karl Storz Endoscopy injection needles used in surgery may not be reliably cleaned by hand, exposing patients to higher infection risk. The recall affects 4,878 units.
Exactech Equinoxe Reverse Shoulder implants have been recalled due to loss of vacuum in the storage bag. The manufacturer received 3 complaints involving 4 devices.
Stryker Spine is recalling 9 units of the LITe Decompression Snake Arm due to an incorrect clamp component that prevents proper attachment to the arm post shaft. Affected units were distributed in the US and internationally.
Siemens is recalling RAPIDPoint 500 Systems Measurement Cartridges because the sodium sensor can develop a negative measurement bias that could delay diagnosis of serious electrolyte disorders or cause treatment errors.
Exactech is recalling the Novation Hip System due to loss of vacuum in the sterile packaging. The company has received complaints about this defect affecting 4 devices.
Exactech is recalling specific models of its Equinoxe Shoulder System implants due to loss of vacuum in the inner-most vacuum bag. Four devices have been affected according to three complaints received.
Karl Storz Endoscopy is recalling injection needles used in general and visceral surgery due to concerns that the manual cleaning process cannot ensure adequate sterilization, which may increase infection risk.
Siemens RAPIDPoint 500 measurement cartridges may produce inaccurate sodium readings, risking delayed diagnosis of dangerous electrolyte imbalances or unnecessary treatment.
Karl Storz Endoscopy is recalling injection needles and cannulas because the manual cleaning process may not effectively remove contaminants, potentially exposing patients to infection risk.
Exactech recalls certain Truliant Knee System units due to loss of vacuum in the inner vacuum bag. The affected units were distributed across multiple U.S. states and international locations.
Exactech is recalling two catalog numbers of Vantage Ankle System devices due to loss of vacuum in the inner-most vacuum bag. Three complaints have been received relating to four affected devices.
Karl Storz Endoscopy is recalling injection needles used in general and visceral surgery because the manual cleaning process cannot be assured effective, which may expose patients to a higher risk of infection.
Exactech is recalling specific catalog numbers of the Optetrak Knee Implant System due to loss of vacuum in the protective inner bag. Three complaints affecting four devices have been reported.
Siemens is recalling RAPIDPoint 500 measurement cartridges because the sodium sensor can produce inaccurate readings, potentially leading to delayed diagnosis or incorrect treatment of electrolyte imbalances.
AC power adapters for LIFEPAK 15 Monitor/Defibrillators may fail to charge batteries or power on the device. Physio-Control is recalling 18,732 units manufactured between November 2021 and April 2023.
CardioQuip LLC is recalling 2 units of its Model MCH-1000(m) Modular Cooler-Heater due to potential bacterial contamination that could result in patient infection. The affected devices are distributed in California, Texas, Pennsylvania, Washington, Ohio, and Nebraska.
Philips is recalling Azurion ceiling-mount imaging systems because a rotation cover may fall if the L-arm collides with hospital equipment, potentially causing injury or affecting sterilization.
Siemens epoc NXS blood analysis systems have a software defect causing incorrect test results to be printed or transmitted. Results may include data from previous patients, potentially leading to misdiagnosis.
Exactech is recalling Vantage Mobile Bearing Tibial Inserts due to loss of vacuum in the innermost vacuum bag. Three complaints involving four devices have been reported.
Abbott CELL-DYN Ruby and Sapphire hematology analyzers contain latex that is not labeled on the device, posing a risk to users with latex allergies. The recall affects 670 devices distributed across 33 states, Puerto Rico, and Brazil.
Maquet Medical Systems USA is recalling venous probe connection cables for the Cardiohelp-i System due to insulation and wire breaks. Defective cables may prevent the system from receiving critical blood flow and temperature information.
Exactech is recalling Truliant and Activit-E knee replacement inserts for loss of vacuum in storage packaging. The defect was identified in 3 complaints involving 4 devices, with no reported injuries.
Zeus Scientific recalls ZEUS ELISA Parvovirus B19 IgM test kits due to an unapproved modification to the test conjugate that was implemented without FDA review and approval.
Vero Biotech is recalling GENOSYL DS Generation 3 cassettes that failed to meet manufacturing flow specifications. The recall affects 2 units distributed in Arizona and Florida.
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