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.
Mueller Sports Medicine is recalling Hybrid Wraparound Knee Supports because they contain natural rubber despite being labeled as latex-free.
Mediana Co., Ltd. is recalling 180 Attendant Vital Signs Monitors because failures were found in the temperature measurement function while in predict mode.
LivaNova is recalling 325 Vein Irrigation Cannulas because internal tests found potential breaches in the sterile barrier, which could compromise sterility.
Smiths Medical is recalling 20 pediatric tracheostomy tubes because one lot was packaged with the wrong size flange plate.
Westmed, Inc. is recalling Neo-Vent Infant T-Piece Resuscitation Circuits because a mold repair resulted in non-compliant 15mm OD connections that prevent use with compatible infant resuscitators.
Ortho Clinical Diagnostics is recalling VITROS 5600 Integrated System software versions 3.3.3 and below because assay parameters may reset to defaults.
ROi CPS LLC is recalling 200 Respirator Crash Cart Kits because the kits are labeled with an expiration date later than the soonest component to expire.
Ortho Clinical Diagnostics is recalling VITROS XT 7600 Integrated System software versions 3.5.1 and below because MicroWell Qualitative Assay parameters may reset to defaults.
ROi CPS LLC is recalling 24 Isolation Droplet Bundle Kits because the kits are labeled with an expiration date later than the expiration date of the soonest component.
Ortho Organizers is recalling Maestro Orthodontic Brackets due to mislabeling. The recall involves 147 kits distributed to US and international consignees.
Ethicon, Inc. is recalling specific lots of PERMA-HAND/MERSILK and VIRGIN SILK Blue twisted Silk Sutures because they may not meet the required 5-year shelf life.
Ortho Clinical Diagnostics is recalling 27 refurbished VITROS 3600 Immunodiagnostic Systems because assay parameters may reset to defaults, potentially affecting test results.
Ortho Clinical Diagnostics is recalling 130 refurbished VITROS 5600 Integrated Systems because software modifications to assay parameters may be inadvertently reset to default.
Ortho Organizers is recalling Maestro Orthodontic Brackets due to mislabeling. The recall affects 104 packages distributed to US and international consignees.
Westmed, Inc. is recalling Neo-Vent Infant T-Piece Resuscitation Circuits because a manufacturing error resulted in non-compliant 15mm OD connections, preventing use with compatible infant resuscitators.
Ortho Clinical Diagnostics is recalling VITROS 3600 Immunodiagnostic System software versions 3.3.3 and below because MicroWell Qualitative Assay parameters may reset to defaults.
Westmed is recalling Neo-Vent Infant T-Piece Resuscitation Circuits because a mold repair resulted in non-compliant 15mm OD connections, preventing use with compatible infant resuscitators.
Mevion Medical Systems is recalling eight MEVION S250i and S250 Proton Radiation Treatment Systems because a software error can cause couch correction moves to be partially lost.
Siemens is recalling 927 Atellica Solution IM1300 Analyzers because they may fail to detect insufficient samples when using specific sample cups.
Suntech Medical is recalling Oscar 2 blood pressure monitors because the display may show an incorrect decimal point for three-digit readings in mmHg.
Zest Anchors LLC is recalling Locator Overdenture Implant Systems because the abutments may be out of specification, potentially causing a gap between the implant and abutment.
Hocoma AG is recalling 494 Lokomat Pro units because a motor controller failure may cause the body weight support rope to move up or down in an uncontrolled way.
Tosoh Bioscience Inc is recalling 529 AIA-900 Analyzers because the substrate monitoring system may fail to detect empty bottles, leading to erroneous immunoassay test results.
Merge Healthcare is recalling specific versions of Merge Cardio software due to a calculation error that may produce false negative Z-Scores.
GE Healthcare is recalling CARESCAPE Patient Data Modules because they may display false flat-line ECGs and asystole alarms when used with an AED.
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