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.
Philips is recalling PageWriter TC50 devices because end-of-life batteries may overheat, melt, or ignite, posing injury risks to patients and users.
Philips is recalling PageWriter TC30 ECG devices because end-of-life batteries may overheat, melt the case, or ignite, posing injury risks to patients and users.
Philips is recalling PageWriter TC70 cardiographs because end-of-life batteries may overheat, melt, or ignite, posing injury risks to patients and users.
Philips is recalling PageWriter TC70 cardiographs because end-of-life batteries may overheat, melt the case, or ignite, posing a risk of injury to patients and users.
Teleflex Medical is recalling 80 units of Pilling Cooley Sump-Suction Tubes because a missing internal tip prevents the device from functioning as intended.
Intuitive Surgical is recalling da Vinci Harmonic ACE Curved Shears because sterile packaging may be damaged during transit, potentially compromising sterility.
Baxter is recalling 7,688 AMIA Automated Peritoneal Dialysis Systems due to a software defect that may cause shortened dwell times during therapy.
Cook Inc. is recalling 24 units of Check-Flo Performer Introducers because they were manufactured with sheaths longer than specified.
Shimadzu is recalling 13 TRINIAS imaging systems due to software crashes and rare display corruption that may hinder medical examinations.
bioMerieux, Inc. is recalling VITEK 2 AST-N351 Test Kits distributed in the UK and Ireland because they may produce false positive results for ESBL phenotypes.
Medtronic is recalling 731 Power Supply 26907 and CareLink Encore 29901 Programmer units due to a potential electrical short circuit that can cause heating and smoke.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products VALP Reagent Packs because they may produce negative bias results when measuring valproic acid.
Boston Scientific is recalling 49 Stingray Guidewires that are 185cm but incorrectly labeled as 300cm. The mislabeling could lead to improper use during angioplasty procedures.
Ortho Clinical Diagnostics is recalling Vitros Myoglobin Calibrators due to a stability issue that may cause calibration failures or atypical quality control results.
Randox Laboratories is recalling Calcium reagents due to a technical bulletin update regarding reagent carryover, which may cause inaccurate test results.
Smiths Medical ASD Inc. is recalling arterial blood sampling kits because the included povidone iodine prep pads may not maintain potency through their expiration dates.
Leica Microsystems is recalling 142 PROVEO 8 Ophthalmic Microscope Systems worldwide due to software anomalies that may cause unexpected movement interruptions or delayed function stops.
Randox Laboratories is recalling Calcium reagents due to a technical bulletin update regarding reagent carryover. This issue may cause falsely elevated or decreased results in patient and QC samples.
Smiths Medical ASD Inc. is recalling Portex Pulsator Arterial Blood Sampling Kits because the included povidone iodine prep pads may not maintain potency through their expiration dates.
Elekta is recalling MOSAIQ Oncology Information Systems because missing wedge IDs may cause patients to receive higher radiation doses than planned.
AtriCure is recalling 6,176 units of the COBRA FUSION 150 Ablation System because patients may face an elevated risk of thromboembolism during specific off-pump procedures.
AtriCure is recalling 765 units of the COBRA FUSION 150 Ablation System due to a potential elevated risk of thromboembolism during specific off-pump procedures.
Medtronic is recalling specific dual chamber pacemakers due to a circuit error that may affect device functionality when programmed to atrial-sensing mode.
Medtronic is recalling specific Versa, Adapta, and Sensia pacemakers distributed worldwide from 2017 to 2019 due to a potential circuit error that may affect device functionality.
Medtronic is recalling SENSIA dual chamber pacemakers due to a potential circuit error that may affect device functionality when programmed to specific modes.
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