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.
Medline is recalling bleach wipes that may lose potency before expiration, potentially allowing pathogens to survive.
OBP Medical is recalling ER-Spec Single-Use Vaginal Speculums because a burr on the plastic blade may create a sharp edge, posing a risk of injury to patients and providers.
Cardinal Health is recalling Presource Kits containing MEDICOM Ritmed Neurological Sponges due to unexpected variability in endotoxin levels.
Medline Industries is recalling Micro-Kill Bleach Germicidal Wipes because bleach concentration may drop below specification, potentially compromising disinfection effectiveness.
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.
Medline Industries is recalling Micro-Kill Bleach Germicidal Wipes because reduced bleach concentration may compromise disinfection effectiveness.
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.
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.
Cardinal Health 200, LLC is recalling 52,699 Presource surgical kits because they contain MEDICOM Ritmed Neurological Sponges with unexpected endotoxin variability.
Cardinal Health is recalling 616 Presource Kits because they contain sponges with unexpected endotoxin variability.
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.
Philips is recalling 2,016 Azurion interventional fluoroscopic x-ray systems worldwide due to software defects that may degrade image quality or lose geometry movements, potentially delaying therapy or causing procedural complications.
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 Azurion Rystem X-ray systems due to software defects that may degrade image quality or lose geometry movements, potentially delaying therapy or causing procedural complications.
FDA is recalling Surgipro sutures due to potential sterile barrier defects that could cause biocontamination and infection.
Cardinal Health is recalling 602 Presource surgical kits because they contain MEDICOM Ritmed Neurological Sponges with unexpected endotoxin variability.
Cardinal Health is recalling specific Presource Kits containing MEDICOM Ritmed Neurological Sponges due to unexpected variability in endotoxin levels.
Covidien, LP is recalling V-Loc 90 Absorbable Wound Closure Devices due to potential sterile barrier packaging defects that may cause biocontamination.
Remel Europe Ltd. is recalling specific lots of Neisseria meningitidis Gp C in vitro diagnostics that fail to meet performance criteria.
Spacelabs Healthcare is recalling 6,074 Xhibit Central Station units because an off-the-shelf DisplayPort audio/video splitter component may fail.
Straumann USA LLC is recalling 175 units of BLT dental implants that may be 12mm instead of the labeled 14mm length.
Galt Medical Corporation is recalling 114,260 Boston Scientific Enhance Transcarotid/Peripheral Access Kits because black depth markings may detach from the outer sheath.
Straumann USA LLC is recalling 417 GM Helix dental implants because the implant inside the packaging may not match the outer carton label, potentially causing installation issues.
Terumo Medical Corporation is recalling 7,490 units of Glidesheath Slender A-Kits because they were packaged with a 0.025 guidewire instead of the specified 0.021 guidewire.
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