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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.
Paragon 28, Inc. is recalling a custom-made foot implant due to elevated oxygen levels that may reduce material ductility.
Gentherm Medical is recalling 182 Blanketrol II Model 222S thermal regulating systems because overheating of the 115V CPU board may cause the device to shut down.
Spectral Instruments Inc is recalling 35 Ami HTX units because the 'X-Ray On' banner may briefly disappear during the run readiness check.
Kico Knee Innovation is recalling 78 ARVIS Surgical Navigation System Gen 2 units because an internal sensor issue may cause the eyepiece image to appear tilted.
Spectral Instruments Inc is recalling 40 Lago X units because the 'X-Ray On' banner may briefly disappear during the run readiness check.
FDA is recalling 327 EndoFLIP Systems because a software error incorrectly flags catheters as expired, making them unavailable for clinical procedures.
Paragon 28, Inc. is recalling a custom-made foot implant due to elevated oxygen levels that may reduce material ductility.
Baxter Healthcare is recalling 24,528 units of Duo-Vent Solution Sets due to customer reports of air bubbles in the drip chamber and tubing.
FDA is recalling Surgipro II sutures due to potential sterile packaging defects that could cause biocontamination and infection.
Erbe USA Inc is recalling ERBECRYO 2 Cryosurgical Units because a strong pull on the high-pressure transfer hose may cause the cryoprobe to rupture.
Spectra Medical Devices is recalling Sodium Chloride Injection ampules because manufacturing issues may have compromised sterility, posing a risk of infection or inflammation to patients.
Covidien is recalling Dermalon 4-0 sutures because sterile barrier packaging may be perforated or torn, risking biocontamination and infection.
FDA is recalling V-Loc 180 Absorbable Wound Closure Devices due to potential sterile barrier packaging defects that could lead to biocontamination.
Bioporto Diagnostics is recalling ProNephro AKI Reagent Kits because a non-validated rework process could lead to missed diagnoses of renal disease.
BD Switzerland is recalling 93,700 intravascular extension sets because they may not have received adequate sterilization processing.
Covidien, LP is recalling V-Loc 90 Absorbable Wound Closure Devices due to potential sterile barrier packaging defects that may cause biocontamination.
Medline Industries is recalling Micro-Kill Bleach Germicidal Wipes because bleach concentration may drop below specification, potentially compromising disinfection effectiveness.
FDA is recalling Surgipro sutures due to potential sterile barrier defects that could cause biocontamination and infection.
Cardinal Health is recalling 616 Presource Kits because they contain sponges with unexpected endotoxin variability.
Waldemar Link is recalling Endo-Model tibial plateau replacement sets that incorrectly contain a Pure Hinge plateau, posing a risk of increased wear if implanted.
Cardinal Health 200, LLC is recalling 52,699 Presource surgical kits because they contain MEDICOM Ritmed Neurological Sponges with unexpected endotoxin variability.
Microvention Inc. is recalling 5,500 Bobby Balloon Guide Catheters worldwide due to an increased rate of balloon pinhole defects.
Medline is recalling Micro-Kill Bleach Germicidal Wipes because reduced bleach concentration may compromise disinfection effectiveness, potentially allowing pathogenic microorganisms to survive.
Philips is recalling 4,252 Allura Xper FD interventional fluoroscopic x-ray systems worldwide due to a firmware issue that may cause loss of geometry movements.
Cardinal Health is recalling Presource Kits containing MEDICOM Ritmed Neurological Sponges due to unexpected variability in endotoxin levels.
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