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.
Daye is recalling 3,074 packs of its Initiation 3 Month Regular Flow Bundle because the product lacks 510(k) clearance.
B. Braun is recalling Streamline Bloodline Sets for Dialog because damaged arterial and venous patient connectors may cause micro-air bubbles in the bloodline and air-in-line alarms.
ICU Medical is recalling 23,203 IV administration sets because the burette component is missing an internal shutoff valve intended to stop fluid flow.
Abiomed is recalling Automated Impella Controllers over the potential for purge pressure issues caused by purge retainer failures, covering 9,177 distributed units.
GE HealthCare is recalling 173 Carescape Central Stations running software V3.0.5 because the system can enter a continuous reboot cycle, losing central monitoring of connected patients.
GE HealthCare is recalling 37 Maxicam gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
GE HealthCare is recalling 15 Elscint Varicam gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
Theken Companies is recalling 409 iNSitu Bipolar Hip System head assemblies in a downstream recall after BioPro femoral components failed transit testing, risking sterile barrier issues.
GE HealthCare is recalling three Elscint Helix gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
Cardinal Health is recalling all lots of Salem Sump Anti-Reflux Valves after complaints of valve breakage due to excessive force during use, and is providing additional guidance for use.
GE HealthCare is recalling 28 Elscint SPX6 gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
GE HealthCare is recalling 1,386 Millenium MG/MC gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
GE HealthCare is recalling 11 Elscint Cardial gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
Medline is recalling 8,267,150 Excelsior Medical 0.9% Sodium Chloride prefilled flush syringes because a limited quantity may not meet the required concentration of sodium chloride.
Becton Dickinson is recalling 4,283 BD Phoenix M50 Automated Microbiology Systems after product service credentials used by some technical support teams were accessed by an unauthorized actor.
Philips is recalling 29 Zenition 50 interventional fluoroscopic X-ray systems because corrosion of the image intensifier television control board may cause loss of imaging or poor image quality.
Cardinal Health is recalling all lots of Salem Sump dual lumen stomach tubes with anti-reflux valve after complaints of valve breakage due to excessive force during use.
Becton Dickinson is recalling 1,086 BD BACTEC Blood Culture Systems after product service credentials used by some technical support teams were accessed by an unauthorized actor.
Becton Dickinson is recalling 38 BD Veritor Connect Software units after product service credentials used by some technical support teams were accessed by an unauthorized actor.
Beckman Coulter is recalling 160 DxC 500i Clinical Analyzer modules over a software anomaly that may not apply user-specified manual dilution factors, risking false low or high results.
Cardinal Health is recalling all lots of Salem Sump PVC gastroduodenal tubes after complaints of anti-reflux valve breakage due to excessive force during use.
GE HealthCare is recalling 205 Sopha Medical Vision gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
Cardinal Health is recalling all lots of Salem Sump silicone dual lumen stomach tubes after complaints of anti-reflux valve breakage due to excessive force during use.
Becton Dickinson is recalling 177 BD BACTEC Blood Culture System instruments after product service credentials used by some technical support teams were accessed by an unauthorized actor.
Biomet is recalling 98 ZipTight Acute AC Joint Implants from one lot because of the potential for a missing slotted button assembly.
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