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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.
Beckman Coulter is recalling specific lots of COULTER DxH Diluent due to out-of-specification conductivity, osmolality, and pH. The diluent may produce inaccurate blood cell test results.
Medtronic Catalyft LS Expandable Interbody System spinal implants are being recalled due to out-of-specification device dimensions that may affect proper placement and spinal support.
Medline Industries recalled 15 units of non-sterile PVP solution in EAR CDS kits that were mislabeled as 'Sterile PVP SLN' instead of 'Non-Sterile PVP Solution, Sterile Packaging.' The mislabeling could result in inappropriate use in sterile medical applications.
GE Healthcare is recalling 5,039 TruSignal Wrap Sensor oximeters due to potential defibrillation energy loss, electrical shock risk, and inaccurate measurements. No illnesses have been reported.
GE Healthcare is recalling 512 TruSignal ear oximeter sensors worldwide due to potential defibrillation energy loss, unintended voltage exposure, and measurement inaccuracy risks.
GE Healthcare's TruSignal Adult/Pediatric ear oximeter sensors are recalled worldwide due to potential reduction of defibrillation energy, risk of unintended electrical contact, and inaccurate oxygen measurement.
GE Healthcare is recalling 708 TruSignal Integrated Ear Sensors (medical-grade pulse oximeters) due to potential defects that could reduce defibrillation energy, cause electrical shock, or produce inaccurate measurements.
GE Healthcare is recalling 2,707 TruSignal Integrated Ear Sensors (GTIN 00840682103428) worldwide due to potential reduced defibrillation energy delivery, unintended voltage exposure, and inaccurate measurements.
GE Healthcare is recalling 36,337 TruSignal AllFit Sensor oximeters worldwide due to potential defibrillation energy loss, voltage exposure, and measurement errors.
GE Healthcare is recalling 2,097 TruSignal Sensitive Skin Sensor oximeters worldwide due to risks of reduced defibrillation energy, unintended electrical contact, and inaccurate measurements.
GE Healthcare is recalling 237 TruSignal Integrated Ear Sensors worldwide due to potential failures in defibrillation energy delivery, unintended voltage contact, and measurement inaccuracy.
Quidel Triage Cardiac Panel diagnostic kits are recalled due to a raw material defect causing approximately 30% troponin signal reduction. The defect won't be detected by quality controls, potentially resulting in missed or delayed heart attack diagnosis.
GE Healthcare is recalling approximately 10,451 TruSignal Ear Sensor oximeters worldwide due to potential electrical hazards and inaccurate measurements that could affect patient safety.
TEI Biosciences is recalling 10,159 units of PriMatrix Ag Meshed dermal repair scaffolds due to testing failures that cannot verify endotoxin levels. Procedures for testing bacterial toxin levels during manufacturing quality control were found to be flawed.
TEI Biosciences recalled 7,264 units of PriMatrix Ag Fenestrated dermal repair scaffolds nationwide due to possible out-of-specification endotoxin test results caused by testing methodology defects.
DeRoyal Industries is recalling 306 custom medical procedure packs because the outer package seals could be open or compromised, affecting the sterility of the contents. Affected packs were distributed nationwide.
Wright Medical Technology is recalling the Stryker Infinity Alignment Frame Distal Sub-Assembly due to manufacturing defects that prevent proper assembly. The pin sleeve holes were manufactured too narrow, preventing insertion of pin sleeves and proper device configuration.
Teleflex recalls the Pilling LOWSLEY PROSTATIC TRACTOR STR due to incomplete pre-cleaning instructions in the product manual. The issue affects 32 units distributed nationwide and internationally.
TEI Biosciences is recalling 9,215 units of SurgiMend PRS Meshed, a surgical collagen matrix, due to possible out-of-specification endotoxin test results.
The FDA has recalled BETTA LINK SR Knotless Implant Kits because the drill guides may bend during surgical procedures, potentially releasing metal shavings. This affects surgeons and patients undergoing orthopedic ligament and tendon repair procedures worldwide.
T.A.G. Medical is recalling BETTA LINK SR surgical drill guides due to risk of bending and metal shavings during surgery.
NeuroLogica is recalling OmniTom CT imaging devices due to wheels that may loosen and battery boards that may be contaminated, both of which could prevent the device from operating properly and delay patient imaging.
Intuitive Surgical is recalling 46,033 da Vinci Xi/X Tip-Up Fenestrated Graspers worldwide due to a manufacturing issue that can cause grip breakage, potentially allowing stainless steel fragments to enter the patient.
Full Vision Inc is recalling 1,416 TrackMaster GE T2100-ST2 220V treadmills worldwide due to a drive circuit board defect that can cause the treadmill to stop suddenly, reverse unexpectedly, or accelerate forward, posing a risk of falls or injury.
DeRoyal Industries is recalling 4,225 custom medical procedure packs nationwide because outer package seals may be open or compromised, potentially affecting sterility of the surgical materials inside.
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