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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.
Linkbio Corp. is recalling 14 units of LINK SLED Knee System knee implant components due to risk of early loosening and wear caused by suboptimal implant positioning or inadequate cementing technique. Affected patients should contact their surgeon.
Inpeco laboratory automation systems have a firmware defect that may cause sample ID mis-association, leading to incorrect test results for electrolyte measurements. Potential consequences include abnormal treatment decisions and serious health complications.
Linkbio Corp. is recalling LINK SLED Knee System tibial components due to risk of early aseptic loosening or premature wear caused by suboptimal implant positioning or inadequate cementing during surgery. The manufacturer is updating surgical technique guidance and training.
OttLite Rechargeable UVC Disinfecting Wand model UV10002M emits excessive ultraviolet radiation above safe limits. Approximately 7,376 units were distributed nationwide.
Linkbio Corp. is recalling 13 units of the LINK SLED knee implant component due to risk of early aseptic loosening or increased wear caused by suboptimal surgical positioning or inadequate cementing technique. Amended surgical technique guidance has been provided.
Siemens Healthcare Diagnostics is recalling 18,961 ADVIA Centaur Cortisol diagnostic kits due to negative bias in urine samples causing intermittently low test results that could affect clinical diagnosis.
Steris Corporation is recalling 263,280 surgical light handle covers worldwide because they may separate from the light handle during procedures, potentially compromising the sterile field.
Linkbio Corp. is recalling the LINK SLED Knee System tibial component (15 units) due to risk of early loosening and increased wear from inadequate surgical technique, potentially requiring earlier-than-expected revision surgery.
Vesmatic Cube 80 laboratory automation system firmware can incorrectly identify patient samples, potentially leading to wrong test results and inappropriate treatment. Affected systems include FlexLab, Accelerator a3600, and Aptio Automation units.
Linkbio Corp. recalls the LINK SLED Knee System due to risk of aseptic loosening from improper positioning or cementing technique, potentially requiring revision surgery. Five units affected in US and international distribution.
FDA recalls LINK SLED Knee System tibial components due to risk of aseptic loosening and premature wear. Patients may require revision surgery.
Labories Medical Technologies is recalling injeTAK Adjustable Tip Needles because packaging damage may compromise the sterile barrier, creating a risk of contamination.
Linkbio Corp. is recalling 14 LINK SLED Knee implants due to risk of aseptic loosening and increased wear caused by improper surgical technique. The implants may fail earlier than expected, requiring revision surgery.
Linkbio Corp. is recalling 12 units of the LINK SLED Knee System due to risk of implant loosening and wear that could require revision surgery sooner than expected.
Refurbished VITROS 5600 diagnostic systems may have a defective MicroTip Pack Opener Assembly that fails to properly remove or replace pack caps, potentially causing delayed test results. Ortho-Clinical Diagnostics is recalling 1,148 units distributed nationwide and internationally.
DeVilbiss Healthcare is updating the instruction manual for its 1025 Series Oxygen Concentrator to comply with IEC-60101-1 standard labeling requirements. This recall affects 143,397 units distributed nationwide and worldwide.
Baxter is recalling Hill-Rom pro+ mattress covers that may delaminate, allowing fluid to seep into the mattress. No injuries have been reported.
The LINK SLED Knee System tibial implant may experience early aseptic loosening if not positioned or cemented properly during surgery. Linkbio recommends updated surgical technique training for optimal implant placement.
The MicroTip Pack Opener Assembly on VITROS 5600 systems may fail to remove or replace pack caps properly, making packs unusable and delaying clinical test results. Approximately 4,895 units were distributed.
The LINK SLED Knee System requires updated surgical technique training due to risks of aseptic loosening and implant wear when improperly positioned or cemented. The manufacturer is issuing reinforced surgical guidelines and training to prevent unsatisfactory outcomes.
The MicroTip Pack Opener Assembly in VITROS XT 7600 laboratory analyzers may fail to properly remove or replace reagent pack caps, potentially causing unusable packs and delayed test results. Approximately 2,001 affected units were distributed nationwide and internationally.
DermLite LLC is recalling DERMLITE DL4W diagnostic devices due to incorrect package labeling. The serial number on the package differs from the serial number on the product itself.
Linkbio Corp. is issuing amended surgical technique guidance for its knee implant system to prevent early loosening and wear caused by improper positioning or inadequate cementing.
Richard Wolf surgical forceps may fail to open when used during endoscopic procedures if the endoscope shaft becomes bent. Approximately 838 units are affected worldwide.
ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. The affected kits were distributed in Florida and Missouri.
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