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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.
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 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 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 5,039 TruSignal Wrap Sensor oximeters due to potential defibrillation energy loss, electrical shock risk, and inaccurate measurements. No illnesses have been reported.
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.
Full Vision's TrackMaster treadmill can experience drive PCB malfunctions causing unexpected stopping, reversal, and acceleration. The malfunction affects 264 units distributed worldwide.
Betta Link LG surgical guides used in soft tissue and bone repair may bend under pressure during surgery, potentially releasing metal shavings that could injure patients. The manufacturer is recalling affected units in the U.S. and internationally.
TEI Biosciences is recalling PriMatrix Meshed dermal repair scaffolds due to endotoxin testing failures. The recall affects 33,277 units distributed nationwide.
Siemens Aptio Automation Storage and Retrieval Module has a firmware error that may incorrectly associate test results to patient samples, potentially leading to incorrect patient results. Eighty-three units are affected worldwide.
TEI Biosciences recalls 199 units of Revize Collagen Matrix due to possible out-of-specification endotoxin test results from faulty testing procedures. The product is distributed nationwide.
TEI Biosciences recalls 14,535 units of SurgiMend collagen matrices distributed nationwide due to potential endotoxin testing verification problems. Affected devices cannot be confirmed to meet endotoxin specifications.
TEI Biosciences is recalling 4,832 units of TissueMend Advanced Soft Tissue Repair Matrix due to possible out-of-specification endotoxin test results. No illnesses or injuries have been reported.
TEI Biosciences is recalling SurgiMend 2.0 collagen matrices nationwide due to possible out-of-specification endotoxin test results from issues with in-process and finished goods testing procedures.
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.
Full Vision Inc recalls 95 TRACKMASTER GE T2100-ST2 treadmills with a defective drive PCB that may misread signals, causing the equipment to unexpectedly stop, reverse, or accelerate forward.
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.
GE HealthCare is recalling Giraffe OmniBed neonatal incubators with potentially incorrect secondary latches on bedside panels. An incorrect latch type may have been installed on northeast and/or northwest panels of affected units.
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.
TEI Biosciences is recalling 1,689 units of PriMatrix Ag dermal repair scaffolds distributed nationwide due to potential endotoxin testing deficiencies. Testing procedures may not have been conducted reliably.
SurgiMend 3.0 collagen matrix is being recalled nationwide (13,390 units) due to possible endotoxin contamination from deficiencies in endotoxin testing procedures.
TEI Biosciences is recalling 5,664 units of SurgiMend 4.0 soft tissue reconstruction implants nationwide due to issues with endotoxin testing that may have resulted in out-of-specification test results.
The LinkSymphoKnee Distal Femoral Augment is being recalled because fixation screws were inserted in the wrong direction during manufacturing. The improper placement could affect the implant's structural stability.
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.
T.A.G. MEDICAL PRODUCTS is recalling BETTA LINK LG KNOTLESS IMPLANT KIT because drill guides may bend during surgical use, potentially creating metal shavings that could injure patients.
TEI Biosciences is recalling 30,528 units of PriMatrix Fenestrated dermal repair scaffolds due to possible out-of-specification endotoxin test results. The FDA Class II recall affects wound healing products distributed nationwide.
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