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.
Gk Photonics is recalling ClubMax Laser Projection Series units because the remote interlock dongle may fail to prevent high-power laser exposure.
St Jude Medical is recalling 47 Ellipse VR ICDs worldwide due to damaged aluminum wires that may prevent the delivery of high-voltage therapy.
SenTec AG is recalling 3 sets of Membrane Changer Sets because there is a 5% chance of insufficient electrolyte application during sensor changes.
Comet Technologies is recalling 93 YXLON Cougar Cabinet X-Ray Systems because the door interlocks fail to meet federal performance standards for power disconnection.
MED-EL is recalling 10 SONATAti100 cochlear implants because they failed helium-fine leak tests. The devices were distributed despite not meeting specifications.
ROi Consolidated Service Center is recalling 261 custom surgical packs containing Stryker Pneumosure tubesets that may detach from the cassette, potentially causing gas leaks.
Gk Photonics Inc is recalling the Atom Laser Projection Series because the provided remote interlock dongle does not fully comply with FDA manual reset requirements, posing a risk of high-power laser exposure.
Gk Photonics Inc is recalling the Burstberry Laser Projection Series because the provided remote interlock dongle fails to meet FDA safety requirements, posing a risk of high-power laser radiation exposure.
Abbott is recalling 943 Alinity ci-series System Control Modules because software may fail to detect issues in specific electrolyte assays.
Centurion Medical Products Corporation is recalling 1,224 LVAD Dressing System kits because the sterile packaging may be compromised, posing a risk of infection.
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 Maxim Laser Projection Series because the provided remote interlock dongle may not fully comply with FDA safety requirements, potentially exposing users to high-power laser radiation.
Centurion Medical Products Corporation is recalling 3,250 Daily Driveline Kits because the sterile packaging may be compromised, posing a risk of infection.
Centurion Medical Products is recalling Laceration Tray Kits because sterile packaging may be compromised, posing a risk of infection.
MicroAire is recalling 103 SmartRelease Endoscopic Carpal Tunnel Release Handpieces because the blade may fail to retract when tightened.
Centurion Medical Products is recalling 1,900 Driveline Management Tray Kits because sterile packaging may be compromised, posing a risk of infection.
Centurion Medical Products Corporation is recalling 220 Circumcision Tray kits (Lot # 2019052190) because the sterile packaging may be compromised, posing a risk of infection during newborn procedures.
Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints about leaks, suction problems, and failure to obtain tissue samples.
Bard Peripheral Vascular Inc is recalling 239 units of EnCor Breast Biopsy Probes due to reports of leaks, suction issues, and failure to obtain tissue samples.
Comet Technologies is recalling 77 YXLON Cheetah cabinet X-Ray systems because the door interlock fails to meet federal performance standards for power disconnection.
Biomet 3i is recalling 6 units of Certain Bellatek Titanium Abutments because a manufacturing defect causes the screw head to seat too deep without a positive stop.
Centurion Medical Products is recalling Universal Block Tray kits because sterile packaging may be compromised, posing a risk of infection during regional anesthesia.
SenTec AG is recalling Membrane Changer Inserts due to a 5% chance of missing or reduced electrolyte application during sensor changes.
Medline Industries is recalling endoscopic cleaning brushes because they may detach during use, potentially leaving parts inside endoscopes.
Siemens is recalling two Lantis 8.3 Commander units due to a Microsoft Windows Remote Desktop Protocol vulnerability.
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