Category
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.
Becton Dickinson is recalling 811,200 units of 10 mL syringes due to possible adulteration and non-conforming manufacturing practices.
Sedecal USA is recalling 145 mobile x-ray systems in the US due to a software defect that may apply adult exposure parameters to newborns.
Becton Dickinson is recalling 176,000 units of 10 mL syringes due to possible adulteration and non-conforming manufacturing practices.
Philips Healthcare is recalling 423 Brilliance 64 CT systems in the US due to software defects causing incorrect scan lengths and dose calculations.
Medtronic is recalling RestoreSensor implantable neurostimulators because insufficient coupling during recharging can cause rapid battery depletion and loss of therapy.
Hospira is recalling 2,567 Plum A+ infusion pumps because a calibration error caused false occlusion alarms. The devices were distributed in the U.S. and 13 foreign countries.
Philips Healthcare is recalling Ingenuity Core CT systems due to software defects that cause incorrect scan lengths and dose calculations.
Philips Healthcare is recalling Brilliance iCT SP CT systems due to software defects that cause incorrect scan lengths and dose calculations.
Ortho-Clinical Diagnostics is recalling VITROS 5600 systems due to a software defect that may cause sample aspiration errors, leading to inaccurate or contaminated test results.
Ortho-Clinical Diagnostics is recalling VITROS 3600 systems due to a software timing anomaly that may cause the device to aspirate or dispense into unintended samples, potentially leading to erroneous or contaminated results.
Stryker is recalling 189 Maestro Air Motor pneumatic cranial drill units because grease buildup may cause the orange grease to leak and contaminate surgical wounds.
Philips Healthcare is recalling Ingenuity CT systems due to software defects that cause incorrect scan lengths and dose calculations.
DePuy Synthes is voluntarily recalling Norian Drillable Inject 5 CC-Sterile units because the internal rotary pouch may be labeled with the incorrect powder volume, though the actual contents are correct.
Ellipse A/S is recalling 14 Ellipse ND: YAG Laser applicators because they lack required instructions for calibration procedures and schedules.
Teleflex Medical is recalling 6,390 sterile tracheal tubes because some units labeled as 7mm may actually be 7.5mm.
Beckman Coulter is recalling Uric Acid reagent (OSR6x98) because Dipyrone may cause erroneous, false low results in assays.
Beckman Coulter is recalling Triglyceride OSR6x118 assays because Dipyrone may cause false low results.
Integrated Science Systems is recalling Sure Vue Staph kits due to customer complaints of weak reactions and false negative results.
Remel Inc is recalling Oxoid Nitrocefin reagents because individual bottles may produce weak reactions, leading to delayed or false negative beta-lactamase test results.
Datascope is recalling Mega and Sensation Plus Intra-Aortic Balloon Catheter kits because they were packaged with the wrong instruction manual for the STATLOCK device.
Synthes (USA) Products LLC is recalling 19 units of 1.5 mm Rapid Resorbable Orbital Floor Plates due to potential expiration date discrepancies on outer packaging labels.
DePuy Synthes is voluntarily recalling Norian Drillable Inject 3 CC-Sterile because the internal pouch may be labeled with the incorrect powder volume, though the actual contents are correct.
Synthes (USA) Products LLC is recalling Norian Drillable Inject 10 CC-Sterile units because the internal rotary pouch may be labeled with the incorrect powder volume, though the actual contents are correct.
Philips Healthcare is recalling 160 DigitalDiagnost stationary X-ray systems because the detector may incorrectly signal readiness, resulting in failed image acquisition.
Stryker is recalling 21 FlowPort II Adapters because the arthroscope sits in the adapter 180 degrees in the wrong direction.
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