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.
Elekta is recalling Monaco Radiation Treatment Planning software due to unintended updates to dose and MU values and incorrect bolus assignments.
Welch Allyn is recalling KleenSpec Corded Illuminators because they may be connected to AC power, posing a shock hazard.
Resource Optimization & Innovation LLC is recalling 10 custom surgical kits distributed in Texas and Louisiana because compromised package integrity may affect sterility.
Resource Optimization & Innovation LLC is recalling 77 custom cardiovascular surgical kits because a component's compromised packaging may affect sterility assurance.
Resource Optimization & Innovation LLC is recalling 28 custom cardiovascular surgical kits because a component had compromised package integrity, potentially affecting sterility.
Resource Optimization & Innovation LLC is recalling 84 custom cardiovascular surgical kits because compromised package integrity may affect sterility assurance.
Siemens Medical Solutions is recalling 44 CIOS ALPHA fluoroscopic x-ray systems due to a potential system failure that could interrupt patient procedures.
Siemens is recalling ADVIA Chemistry XPT systems because unplugged electrodes may cause unflagged errors in sodium, potassium, or chloride results.
Philips Medical Systems is recalling 268 Brilliance Big Bore CT systems worldwide due to X-ray measurement errors causing image artifacts.
LifeHealth is recalling BG cartridges for the IRMA TRUPOINT Blood Gas Analyzer because the pH sensor may provide falsely elevated results as the product ages.
LifeHealth, LLC is recalling IRMA TRUPOINT Blood Gas Analyzer CC Cartridges because the pH sensor may provide falsely elevated results as shelf life progresses.
Materialise N.V. is recalling four patient-specific surgical guides for knee arthroplasty because image data processing errors led to inaccurate surgical planning.
Resource Optimization & Innovation LLC is recalling 80 custom cardiovascular surgical kits because compromised package integrity may affect sterility assurance.
Resource Optimization & Innovation LLC is recalling 153 custom cardiovascular surgical kits because compromised package integrity may affect sterility assurance.
Perkin Elmer is recalling Specimen Gate software because abnormal newborn screening test results may be incorrectly interpreted as normal.
Integra is recalling Bone Marrow Biopsy Trays because they contain Hospira Lidocaine vials with visible particulate matter.
Encore Medical is recalling 277 Turon Shoulder Impaction Fixtures because polymer material wore off during assembly, potentially contaminating the implant.
Resource Optimization & Innovation LLC is recalling 17 custom surgical kits in Texas and Louisiana because a component was recalled for compromised package integrity, potentially affecting sterility.
Abbott Laboratories is recalling 65 ARCHITECT i2000SR diagnostic systems worldwide because they contain incorrect tubing.
Encore Medical is recalling 634 units of Reverse Shoulder Prosthesis Stem Impaction Fixtures because polymer wear from the fixtures can damage the titanium coating on humeral stems during assembly.
Siemens is recalling 2,099 ACUSON SC2000 ultrasound systems due to hardware defects involving wheel lock disconnection and system lockups.
Synthes (USA) Products LLC is recalling 25 units of Threaded Plate Holders that are incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate.
Philips Medical Systems is recalling 109 Ingenuity Core 128 CT systems due to X-ray measurement errors causing image artifacts.
Synthes (USA) Products LLC is recalling 98 units of 2.7 mm locking screws that were mislabeled as 2.4 mm. The units were distributed to Tennessee.
Sentinel CH SpA is recalling 765 kits of Sentinel MULTIGENT Ammonia Ultra Reagent because results may be below the linear range for samples collected in heparin tubes.
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