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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.
B. Braun Medical is recalling 540 units of CE17TKN epidural Tuohy needle filters because the filter membrane is damaged, preventing the device from achieving its intended filter capacity.
B. Braun Medical is recalling 200 units of Con Epi Trays because damage to the filter membrane prevents the device from achieving its required filter capacity.
B. Braun Medical is recalling 3,820 units of Accu-Bloc Perifix Kits because damage to the filter membrane prevents the device from achieving its intended filter capacity.
Roche Diagnostics is recalling 19 Cobas 8000 Modular Analyzer Series units due to a quality issue with high pressure solenoid valves.
B. Braun Medical is recalling 200 units of spinal and epidural trays because the filter membrane is damaged, preventing the device from achieving required filter capacity.
LeMaitre Vascular is recalling 62 units of Aortic Occlusion Catheters because the packaging lists the incorrect device size.
Haag-Streit USA Inc is recalling HS Hi-R NEO 900 operating microscopes because a software error in the floor stand's central control unit may affect device function.
Heidelberg Engineering is recalling 29 SPECTRALIS ophthalmic imaging devices because a software configuration error may cause incorrect display of patient master data.
Fujifilm is recalling 174 FDR Go Plus mobile X-ray systems because a graphics driver issue may cause the device to display a Blue Screen of Death.
Boston Scientific is recalling AMS 800 Artificial Urinary Sphincter belt cuffs labeled as 4.5 cm but measuring 4.0 cm due to mislabeling.
Roche is recalling Tina-Quant Myoglobin Gen. 2 assays due to signal drops causing calibration failures and QC imprecision on specific analyzers.
Helena Laboratories is recalling 65 kits of Titan Gel Serum Protein Control due to customer complaints about a narrow assay range.
Roche Diagnostics is recalling two cobas c513 Analyzers due to a quality issue with high pressure solenoid valves.
Coltene is recalling a specific lot of Diatech diamond dental burs because the instruments in the batch vary in length despite having the same shape and grit.
CareFusion 303, Inc. is recalling 76 Alaris EtCO2 capnographs because they may have been calibrated with a lower-than-specified CO2 concentration.
SonarMed Inc is recalling 16 AirWave Monitor units because two error codes may render the devices inoperable.
Karl Storz Endoscopy is recalling 14 Flexible Intubation Fiberscopes because they were improperly manufactured with a double port luer instead of a single port luer.
Haag-Streit USA Inc is recalling HS Hi-R NEO 900A operating microscopes and specific floor stands due to a software error in the central control unit.
AngioDynamics is recalling VenaCure EVLT NeverTouch Procedure Kits because an RFID programming error prevents the product from being used with the laser source.
Alere San Diego, Inc. is recalling 186 Alere Cholestech LDX Analyzer kits because the power supplies have reversed polarity, rendering the devices inoperable.
Getinge is recalling 1,444 boxes of disposable CO2 absorbers because the expiration and manufacturing dates on the labels are reversed.
Bard Peripheral Vascular Inc. is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.
Spectrum Medical Ltd. is recalling 108 Quantum Pump Consoles because they may unexpectedly shut down while in use.
Bard Peripheral Vascular Inc is recalling Equistream XK Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.
Siemens is recalling 17 Artis zee and Artis Q interventional X-ray systems because cracks in the patient table mainframe could cause the upper bed to detach, posing a hazard to patients and staff.
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