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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 recalls Catalyft LS spinal implants due to potential out-of-specification dimensions. The affected devices may not properly fit or function as intended during spine fusion surgery.
GE Healthcare Vivid S70 ultrasound devices may experience delayed startup. This can reduce equipment availability during time-critical emergency situations.
GE Healthcare Vivid S60N ultrasound systems may fail to boot in a timely manner. This can delay device availability during time-critical emergency situations.
Osteomed is recalling orthopedic screws with undersized heads that may pass through bone plates. Affected lot numbers were distributed nationwide in the US and Singapore.
Medline is recalling Total Knee Theda surgical kits where the non-sterile PVP solution was mislabeled as sterile. Healthcare providers should immediately stop using the recalled kits and contact Medline.
Abiomed 14Fr Low Profile Introducer Sets are being recalled due to silicone oil contamination that may cause sidearm detachment during use. One detachment has been documented; no injuries have been reported.
Medline Industries is recalling 128 units of non-sterile PVP solution incorrectly labeled as sterile. Using a non-sterile product in sterile contexts could create infection risk.
Baxter Healthcare recalls 1,010 Allen Advance Chest Support devices due to potential cracking where the support attaches to operating room table rails. No injuries reported.
Medline is recalling Non-Sterile PVP Solution Hystero Pack kits due to mislabeling: affected lots labeled as 'Sterile' when actually 'Non-Sterile'. Using non-sterile solution in sterile gynecological procedures creates infection risk.
Medline is recalling 4,500 surgical kits because the non-sterile PVP solution inside was mislabeled as sterile. Using the mislabeled product in sterile surgical procedures could introduce non-sterile materials into surgical fields.
Medtronic is recalling Catalyft LS spinal implants due to potential out-of-specification device geometries that may not properly accommodate patient anatomy.
Osteomed recalls orthopedic AutoDrive screws used in osteotomy procedures due to undersized screw heads that could pass through the mounting plate hole, potentially affecting surgical fixation.
Medline Industries is recalling 1,500 units of non-sterile PVP solution mislabeled as sterile in ophthalmic and eye surgical kits. Users may unknowingly apply non-sterile solution in eye procedures, risking infection.
Medtronic recalls 10 units of Catalyft LS spinal implants due to potential out-of-specification device geometries. The affected implants may not properly support or accommodate patient anatomy during lumbar fusion surgery.
Stryker Power-PRO 2 ambulance cots may develop bent base leg assemblies, risking cot tips, unstable motion, and operational difficulties. Approximately 1,980 units were recalled.
Medtronic is recalling 11 units of its Catalyft LS Expandable Interbody System spinal implants due to potential out-of-specification dimensions that could affect surgical fit and stability.
Medtronic is recalling eight units of Catalyft LS Expandable Interbody System spinal implants due to potential out-of-specification device dimensions that could affect surgical fitting and spinal stability.
Medtronic recalls 25 units of Catalyft LS spinal implants (lot numbers NM21J039, NM21M026) due to out-of-specification device dimensions that may affect surgical fit and function.
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'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 36,337 TruSignal AllFit Sensor oximeters worldwide due to potential defibrillation energy loss, voltage exposure, and measurement errors.
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 is recalling approximately 10,451 TruSignal Ear Sensor oximeters worldwide due to potential electrical hazards and inaccurate measurements that could affect patient safety.
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