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.
Becton Dickinson is recalling specific lots of Gravity IV Sets with 3-port Closed Stopcock Manifolds due to a confirmed complaint trend for kinked tubing.
Elekta Limited is recalling 12 Unity MRI-guided radiation therapy systems because acquired images may not represent average anatomy during respiratory motion, potentially affecting treatment accuracy.
Becton Dickinson is recalling specific lots of Gravity IV Sets with 3-port Closed Stopcock Manifolds due to a confirmed complaint trend for kinked tubing.
Integra Limited is recalling 232 units of bioBLOCK Resorbable Subtalar Implants because temperature indicators suggest exposure to temperatures greater than 110°F.
Arrow International Inc is recalling 45 units of Two-Lumen Central Venous Catheterization Sets due to incorrect priming volume labeling on the lidstock.
Roche Diagnostics is recalling 656 COBAS INTEGRA 400 plus analyzers because specific tests require additional wash cycles to prevent carry-over.
Johnson & Johnson Vision Care is recalling one lot of ACUVUE OASYS for Astigmatism contact lenses due to potential incomplete packaging seals.
Roche Diagnostics is recalling 137 cobas c 111 and COBAS INTEGRA 400 plus analyzers because specific tests require additional wash cycles to prevent carry-over.
Beaver Visitec is recalling 196 boxes of Xstar Slit Knives because the package label indicates a 2.4 mm size, while the device marking shows 2.75 mm.
Conformis, Inc. is recalling two iTotal CR Total Knee Replacement Systems prepared with incorrect patient ID labels and potentially incorrect components.
Philips is recalling two Azurion FlexArm units because a manufacturing error caused damage to the 24V power cable of the detector.
Arrow International Inc is recalling specific lots of Two-Lumen Central Venous Catheterization Kits because the lidstock displays an incorrect priming volume.
Integra Limited is recalling 232 units of the bioBLOCK Resorbable Subtalar Implant because temperature indicators suggest exposure to temperatures above 110°F.
Ulrich Medical USA Inc. is recalling 25 Torque Limiting Handles because they are beyond their 3-year calibration life.
Integra Limited is recalling 232 units of the bioBLOCK Resorbable Subtalar Implant because temperature indicators suggest exposure to temperatures above 110°F.
Randox Laboratories is recalling 58 units of Immunoassay Premium Controls due to an incorrect target value listed on the analyzer value sheet.
Randox Laboratories is recalling Liquid Immunoassay Premium Controls because the target value for uptake is incorrect on the value sheet.
Randox Laboratories is recalling Immunoassay Premium Plus Controls due to an incorrect target value listed on the analyzer value sheet.
O-Two Medical is recalling 119 e600 Automatic Transport Ventilators because a manufacturing defect may cause the unit to catch fire.
O-Two Medical Technologies is recalling 632 e700 Automatic Transport Ventilators because a manufacturing defect could cause the unit to catch fire.
O-Two Medical is recalling 136 e500 Automatic Transport Ventilators because a manufacturing defect may cause the unit to catch fire.
Zimmer Biomet is recalling 809 units of RingLoc Hip System Self-Tapping Bone Screws due to a potential packaging error where 30mm screws may be labeled as 20mm and vice versa.
Zimmer Biomet is recalling 809 units of RingLoc Hip System Self-Tapping Bone Screws because 30mm screws may have been packaged as 20mm screws, and vice versa.
Zimmer Biomet is recalling 89 units of the Small Diameter Cement Plug Inserter due to a lack of adequate sterilization validation.
Beckman Coulter is recalling UniCel DxC clinical systems where a software scheduling error can cause sample mishandling and generate incorrect test results.
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