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.
BioPro recalled titanium toe implants due to incorrect claims in documentation about magnetic resonance (MR) compatibility testing that was never conducted. The FDA issued a Class II recall to address the misleading safety information.
BioPro Titanium MPJ toe implants are being recalled due to incorrect statements in device labeling claiming MR Conditional status when MR testing was not performed on the titanium version.
Lacrimedics is recalling Collagen Plugs (models CP3, CP4, CP5) due to potential seal integrity defects in sterile pouches. The seals may contain channels that could compromise sterility and allow contamination.
Microbiologics Inc is recalling Helix Elite Molecular Standards for inactivated RSV A because real-time shelf life testing failed at 24 months, indicating the product may not maintain stability through its claimed expiration date.
Wright Medical Technology is recalling the DARCO Locking Bone Plate System because product labels contain incorrect manufacturing and distribution dates. The recall affects 12 units distributed to Japan and the United Kingdom.
A quality control negative control material in GBS diagnostic testing sets is yielding false-positive results, causing laboratory test failures and operational disruptions.
A lot of LYFO-DISK quality control kit was found susceptible to Gentamicin Synergy when it should have been resistant. The 153 affected units were distributed worldwide.
Microbiologics QC sets used for GBS testing contain a negative control contaminated with Group B Streptococcus, causing test failures. Affects 541 units distributed nationwide.
Microbiologics Inc is recalling its Helix Elite Extended Enteric Bacterial Verification Panel because real-time shelf life testing failed at 24 months.
BioPro is recalling Titanium MPJ toe implants because instructions and patient cards falsely claim the devices are compatible with MRI imaging, when safety testing for this titanium version has not been conducted.
Biomet is recalling certain shoulder stem implants due to potential insufficient adhesion strength in the porous plasma coating. An improper rework process may have compromised the coating's integrity.
Biomet is recalling a shoulder implant stem due to a manufacturing defect in the porous plasma coating. Internal testing indicated the coating may not have sufficient adhesion strength after an unvalidated waterjet rework process.
Collagen Matrix is recalling 68 units of DuraMatrix-Onlay Collagen Dura Substitute Membrane due to unsealed outer packaging that may compromise product sterility and increase infection risk.
Natus Neurology is recalling IPELA FHD PTZ tile kits that may not fit properly in thinner ceiling tile grids and could suddenly fall, creating a safety hazard.
Biomet is recalling a Comprehensive Shoulder System implant component due to a defect in the porous plasma coating. The coating may not have sufficient adhesion strength, compromising the implant's structural integrity.
Biomet is recalling 19 units of the Arcos Modular Revision Hip System because an incorrect rework process may have weakened the coating's adhesion strength, posing a potential implant failure risk.
Biomet is recalling Comprehensive Shoulder System Mini Humeral Stems due to defective porous plasma coating adhesion. Internal testing indicated affected parts may lack sufficient coating strength.
Nobel Biocare is recalling 702 NobelReplace dental implant components due to a manufacturing defect that prevents proper driver engagement. The defect could result in aborted or delayed surgical procedures.
Stryker Sustainability Solutions is recalling 40 units of Color Cuff 18" tourniquet cuffs (Lot #12983349) because they are mislabeled as single-bladder when they are actually dual-bladder, creating a risk of incorrect clinical use.
BD's Vacutainer Luer Lok Access Device may release contaminant particles that can be misidentified as red blood cells in laboratory analysis, potentially leading to false elevated RBC counts.
Biomet is recalling shoulder implant stems due to improper rework of porous plasma coating, which may lack sufficient adhesion strength. Affected units may fail if the coating detaches.
Certain Medtronic Endurant stent graft systems may have taper tips that detach from the delivery system during implant procedures, potentially requiring secondary surgical intervention.
C.R. Bard is recalling 2,120 units of the BARD SURESTEP INTERMITTENT CATHETER TRAY (14Fr) due to a potential leak at the catheter-to-drain-bag connection.
C.R. Bard Inc recalled 1,620 units of Bard Surestep Intermittent Catheter Tray because the catheter may leak where it connects to the drain bag. No injuries have been reported.
Biomet recalls 11 units of its Comprehensive Shoulder System Mini Humeral Stem due to potential coating adhesion defects. An unvalidated rework process was applied to vendor-coated parts, risking implant failure.
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