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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.
Ossur Americas is recalling various orthopedic braces and medical devices, including knee braces and back supports, due to a defect described as 'the p'.
Siemens Medical Solutions is recalling 89 Cios Alpha mobile X-ray systems due to software issues. The units were distributed nationwide to 30 states.
Siemens is recalling four Cios Alpha mobile X-ray systems because a defective part could increase the risk of electrical shock for service personnel during maintenance.
Siemens is recalling 124 CT systems due to a potential malfunction hazard when using specific cardio licenses.
Ossur Americas is recalling various medical devices, including Miami J collars and knee shields, due to a manufacturing defect.
ICU Medical is recalling specific I.V. infusion administration sets because a connection may develop a leak. The recall affects 350 units distributed in the US and internationally.
Ossur Americas is recalling various medical devices, including knee braces and walkers, due to unspecified product issues.
Medtronic is voluntarily removing a single Ascenda Intrathecal Catheter kit due to incorrect outer package labels that may result in missing components.
Philips Medical Systems is recalling 4,180 foot switches used with Allura Xper systems because a bent pedal can cause loss of key image functionality.
Medtronic is recalling Reveal LINQ insertable cardiac monitors because an algorithm issue may trigger replacement alerts prematurely. The device battery and data collection capabilities remain functional.
Implant Direct Sybron is recalling GoDirect Implants because some consignees received the wrong tool to drive the implant to bone level.
Siemens is recalling 1,757 Artis zee/zeego angiographic X-ray systems because a possible leak in the cooling system could allow fluids to seep into the equipment cabinet.
Siemens is recalling 3,090 E.CAM gamma camera systems to provide supplemental instructions and visual aids for proper collimator changes.
Biomet Spine is recalling specific Solitaire Ti Spacers because they are mislabeled as having a 12-degree lordotic angle when the actual angle is 6 degrees.
Siemens is recalling one Artis One angiography system because imported left atrium segmentation results may be incorrectly mirrored to a 3D mapping system.
Siemens is recalling 726 Symbia gamma camera systems worldwide to provide supplemental instructions clarifying the proper collimator change procedure.
Philips Medical Systems is recalling 168 foot switches used with the MultiDiagnost Eleva system because a bent pedal can cause loss of key image functionality.
Innovative Ophthalmic Products is recalling Molteno3 Glaucoma Implants because the package insert was updated to add a caution statement to minimize off-label use.
Beckman Coulter is recalling MicroScan LabPro software because it allows incorrect manual editing of carbohydrate substrates for specific test panels.
Pelton & Crane is recalling 156 Helios HL3T and HLT track mounted dental lights because they were missing two set screws during initial installation.
Wfr/aquaplast Corp is recalling 30 prone breast treatment tables and devices because some may have misaligned scales, potentially causing orientation differences.
Ossur Americas is recalling various medical devices, including knee shields and walkers, because the packaging is defective.
Siemens Healthcare Diagnostics is recalling IMMULITE 1000 Estradiol Test kits because the drug Faslodex may cause falsely elevated results.
The FDA is recalling specific lots of Aplicare Castile Soap towelettes found in medical kits due to bacterial contamination.
Covidien LLC is recalling Castile soap towelettes found in Foley trays and specimen kits because they are contaminated with bacteria.
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