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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.
Centurion Medical Products Corporation is recalling 168 Circumcision Tray kits because sterile packaging may be compromised. The kits are used for newborn circumcision procedures.
Centurion Medical Products is recalling 48 SNAG FREE SUTURE TRAY kits because sterile packaging may be compromised, posing a risk of infection.
SenTec AG is recalling 198 Membrane Changer units because a defect may result in insufficient electrolyte application during sensor changes.
Centurion Medical Products is recalling sterile Graves vaginal speculums because the sterile packaging may be compromised, potentially exposing patients to infection.
Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints about leaks, suction issues, and failure to obtain samples.
MED-EL is recalling seven Mi1000 CONCERTO cochlear implant devices because they were distributed despite failing helium-fine leak tests. The devices are intended for severely to profoundly hearing impaired individuals.
Centurion Medical Products is recalling 400 sterile fluoro SSP trays because the sterile packaging may be compromised. The kits are used for arthrogram injection and aspiration.
SenTec AG is recalling Neonatal Starter Sets due to a 5% chance of missing or reduced electrolyte application during membrane changes.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products GLU Slides due to potentially biased results.
Biomet 3i is recalling 3 units of Bellatek Tin Abutments because a manufacturing defect causes the screw head to seat too deep without a positive stop.
Hycor Biomedical is recalling HYTEC 288 System and RF assay kits because high IgG levels may cause false positive results, leading to incorrect rheumatoid diagnoses.
ROi is recalling 312 custom surgical packs containing Stryker Pneumosure tubesets due to a risk of tube detachment and gas leakage.
SenTec AG is recalling Standard Starter Sets due to a risk of missing or reduced electrolyte application during the membrane change procedure.
Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints about leaks, suction issues, and failure to obtain samples.
Gk Photonics is recalling the Spectrum Laser Projection Series because the included remote interlock dongle may fail to prevent high-power laser radiation exposure.
Gk Photonics is recalling Logolas Laser Projection Series units because the remote interlock dongle may not fully comply with FDA safety requirements, posing a risk of high-power laser exposure.
Olympus is recalling MAJ-209 Single Use Suction Valves because they may come apart or remain stuck inside endoscopes.
Fresenius Medical Care is recalling Liberty Cycler Cassettes because damaged units may leak dialysis solution into the cycler, posing a contamination risk.
Centurion Medical Products is recalling 120 Neonatal PICC Insertion Trays because the sterile packaging may be compromised, posing a risk of infection.
Integra LifeSciences is recalling 125 units of Codman ISOCOOL Bipolar Forceps because inadequate insulation coating may prevent proper tissue coagulation during surgery.
MED-EL is recalling PULSARci100 Cochlear Implants because they failed helium-fine leak tests. Affected devices were distributed in the US and several international countries.
Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints of leaks, suction issues, and failure to obtain tissue samples.
Ortho Clinical Diagnostics is recalling 89 VITROS 5600 clinical chemistry analyzers worldwide due to a software anomaly that may cause unsuccessful calibrations.
Philips is recalling 116 CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Biomet 3i is recalling 2 units of Bellatek Tin Abutments because a manufacturing defect causes the screw head to seat too deep without a positive stop.
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