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.
GE HealthCare is recalling 292 Millenium MPR gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
GE HealthCare is recalling 45 Elscint SPX4 gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
Baxter is recalling 5,209 oral probes for Welch Allyn SureTemp Plus thermometers that were inadvertently programmed with the rectal probe configuration and may read low.
GE HealthCare is recalling 82 Millenium Myosight gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
HeartSine Technologies is recalling 1,291,165 Pad-Pak units because defibrillator pads may contain damaged pins that disrupt the mechanical fit and electrical contact.
GE HealthCare is recalling 64 Elscint Model 4XX gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
Tandem Diabetes Care is recalling 122,958 t:slim X2 and Mobi insulin pumps because a software defect when paired with a Dexcom G7 sensor may trigger an unexpected automatic correction bolus.
Becton Dickinson is recalling 2,050 BD EpiCenter Microbiology Data Management Systems after product service credentials used by some technical support teams were accessed by an unauthorized actor.
Beckman Coulter is recalling 571 DxI 9000 Access Immunoassay Analyzers over a software anomaly that may not apply user-specified manual dilution factors, risking false low or high results.
GE HealthCare is recalling one Optima NX gamma camera because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
GE HealthCare is recalling 54 Millenium MPS 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 ENFit Salem Sump PVC tubes after complaints of anti-reflux valve breakage due to excessive force during use.
GE HealthCare is recalling 102 Starcam and Camstar 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 dual lumen stomach tubes after complaints of anti-reflux valve breakage due to excessive force during use.
GE HealthCare is recalling 2,306 Carescape Central Stations running software V3.0.5 because the system can enter a continuous reboot cycle, losing central monitoring of connected patients.
Becton Dickinson is recalling 62 BD MAX System instruments after product service credentials used by some technical support teams were accessed by an unauthorized actor.
GE is recalling 29,225 MAC VU360 acquisition trunk cables and module holders because incorrect placement of the module can wear the cable until it overheats in use.
Sedecal is recalling the SHIMADZU RF.004 mobile X-ray system, serial 75723, after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling one SM_40HF_BDC3 mobile X-ray system after emailing consignees to remind users that the equipment is not water-resistant.
UIH Technologies is recalling two uCT 780 computed tomography systems because third-party outer covers can become trapped between the patient table and gantry.
Sedecal is recalling one SM-20HF-Batt 20KW analog mobile X-ray system after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling one mobile X-ray system after emailing consignees to remind users that the equipment is not water-resistant and must be cleaned strictly per the manual.
UIH Technologies is recalling 11 uCT 760 computed tomography systems because third-party outer covers can become trapped between the patient table and gantry.
Synthes is recalling 122 low profile locking screws because 42mm screws were packaged and labeled as 46mm and 46mm screws were labeled as 42mm, though the etched length is correct.
Sedecal is recalling 56 SM-40HF-B-D-KM (AeroDR X30) mobile digital diagnostic X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
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