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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.
Skytron recalls its GCX Channel Mounting Accessory (model H8-300-40-A) because mounting screws may loosen or pull out when used as a monitor mount on surgical booms. Affected units were distributed worldwide.
One lot of DVR Anatomic distal radius orthopedic plates was incorrectly etched during manufacturing and may have been placed into kits labeled as a different plate model. The affected plates were distributed to healthcare facilities nationwide.
The ProudP Everyday Uroflow Tracker app may record lower-than-actual urination measurements when a hearing aid or AirPods Live Listen feature is active on the same iPhone, due to interference with the app's sound-based measurement system.
Medline is recalling over 840,000 pill splitters due to a defect where the product lid can come unhinged, exposing a sharp blade and posing a laceration risk.
ROi CPS LLC is recalling 180 CV Minor Kit units due to a nonsterile component accidentally packaged in the sterile kit, posing a contamination and infection risk.
C.R. Bard is recalling 457 Sensica Urine Output System units nationwide due to complaints about urine output measurement accuracy.
Siemens Artis Pheno fluoroscopic X-ray systems may lose video signals from the Large Display during procedures. In rare cases, both transceivers could fail, affecting displays in the examination and control rooms.
Davol, Inc. is recalling the HydroSurg Plus Laparoscopic Irrigator because the device cannot provide irrigation as intended. The recall affects 4,390 units in the US and 390 in Canada.
RayStation 11B radiation therapy planning software has two display issues affecting Linear Energy Transfer values. These errors could lead to incorrect dose calculations if not identified during clinical review.
Haemonetics' TEG5000 Analyzer displays incorrect PlateletMapping assay values when connected to TEG Manager Software versions 1.1–4.3.1, potentially affecting laboratory test interpretation.
Wright Medical is recalling 35 units of the Stryker INFINITY Resect Guide for INBONE Talus (Model #33620254) due to incorrect color coding. The color coding error could lead to misidentification and improper use during ankle surgery.
Olympus is recalling certain SOLTIVE SuperPulsed Laser Fibers because device model and size may be mismatched between packaging and the actual device. This could result in the wrong laser fiber being used in medical procedures.
K2M Inc. is recalling certain Yukon Straight Rod spinal implants due to discoloration from trace amounts of inorganic phosphorous compound. The contaminated devices may cause mild irritation or adverse tissue reactions.
Davol HydroSurg Plus Laparoscopic Irrigators cannot provide irrigation. The FDA issued a Class II recall affecting 4,780 units worldwide.
Atrium Medical Corporation is recalling Atrium Firm PVC Thoracic Catheter 28French due to an expiration date mismatch between the sterile barrier pouch and case labels. The discrepancy allowed product to be used up to five days past its true expiration date.
Haemonetics Corporation is recalling TEG 5000 Functional Fibrinogen Reagent kits because the reference ranges in the instructions have shifted. Clinicians using these outdated ranges could misdiagnose patients or fail to provide necessary treatment.
The NaviCare Nurse Call system software (versions 3.9.100-3.9.300) has a wireless integration defect causing patient calls to be canceled when answered on wireless phones. The issue affects 283 installations in the US and Canada.
GE Healthcare recalls backup batteries for anesthesia devices worldwide that may fail earlier than expected. The batteries are used in Avance CS2, Avance, Amingo, and Aespire View systems.
Arrow International is recalling the Arrow Three-Lumen CVC due to incorrect gravity flow rates on the product lidstock. The defect may affect fluid and medication delivery through the catheter.
The Alphenix 4D CT system may fail to operate due to a system error that activates an interlock restriction. Six affected systems were distributed to hospitals in five U.S. states.
Paint particles may detach from VOLISTA StandOP Surgical Lights and fall into the operating field during surgery, risking infection and organ irritation. Getinge Usa Sales Inc is recalling 337 affected units in the United States.
Baxter Healthcare Corporation is recalling MAC laryngoscope devices due to a packaging error. The recall affects 99 units distributed worldwide.
Fresenius Medical Care is recalling 19 cases of Optiflux 200NRe dialyzers distributed in Pennsylvania after exposure to cold temperatures outside safe storage ranges. Affected lot number is 22AU04017.
Volcano Corp is recalling Visions PV. 035 Digital IVUS Catheters because instructions for use do not include contraindications information. Healthcare providers should contact the manufacturer for complete safety documentation before use.
Volcano Corp is recalling 7,520 units of the Volcano Visions PV. 035 Digital IVUS Catheter due to missing contraindication information in the instructions for use. The IFU lacks details about situations where the device should not be used.
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