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.
Amerx Health Care Corp. is recalling 6,993 units of Amerigel Hydrogel Wound Dressing Advanced Formula because the product did not meet specifications for Zinc Acetate.
The Anspach Effort, Inc. is recalling 18 Anspach G1 High Speed Electric Handpiece Air Cooled units because the graphics indicating locked and unlocked positions are reversed.
Nobel Biocare is recalling 53 Replace Select Tapered dental implants due to incorrect top labels on the packaging. The recall covers units distributed in the US and internationally.
Terumo CVS is voluntarily recalling Sarns TCM II heater-cooler units because the Interchlor sanitizer referenced in cleaning instructions is no longer available.
Siemens Medical Solutions is recalling 50 units of Syngo.via PACS software due to incorrect volume calculation values. A software update is available to resolve the error.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur XPT system software versions V1.0.1 through V1.1 due to eight identified issues that may affect test results.
Terumo CVS is voluntarily recalling Sarns Dual Cooler-Heater devices because the distributor no longer sells the Inter chlor sanitizer required for cleaning.
Becton, Dickinson and Company is recalling one lot of BD Trucount Absolute Counting Tubes because they may not be sealed properly, which can degrade product performance.
WalkMed Infusion is voluntarily recalling specific IV administration sets due to the potential presence of particulate matter in or on the devices.
CSL Behring is recalling 898 units of Dimension Vista Homocysteine Flex Reagent Cartridges because opened lots show reduced stability and do not meet the 7-day claim.
Hologic is recalling 16,870 ATEC Suction Canisters because the lids may crack. These devices are used to collect fluid during breast biopsies.
WalkMed Infusion is recalling Triton and Triton FP infusion pumps due to unapproved changes to software, specifications, and intended use.
DePuy Synthes is voluntarily recalling TFNA Blade/Screw Guide Sleeves because a manufacturing defect may prevent proper use, potentially causing surgical delays.
Toshiba is recalling 23 Angio WorkStation systems because a software error caused the displayed Peak Skin Dose to be higher than expected during specific procedures.
Terumo CVS is voluntarily recalling Sarns TCM units because the Interchlor sanitizer referenced in cleaning instructions is no longer sold by the distributor.
Heartware, Inc. is recalling 18,631 HeartWare Ventricular Assist System batteries due to premature depletion. The recall covers devices distributed nationwide in the US.
Hospira is recalling 6,268 LifeCare Pump Model 4200 PCA Infusers because they may fail to detect distal occlusions, a defect that caused one serious injury.
Hospira is recalling 8,216 PCA 3 infusion pumps because normal wear on a component may prevent the device from detecting distal occlusions, a defect that resulted in one serious injury.
Hospira is recalling 53,151 LifeCare PCA Plus II infusion pumps because wear on a component may prevent the detection of distal occlusions, resulting in serious injury.
Hospira is recalling 38,878 LifeCare PCA infusion systems because wear on a component may prevent the pump from detecting distal occlusions, a defect that has resulted in one serious injury.
Hardy Diagnostics is recalling 25 QuickSlide MGS-80 and GramPRO-80 automated Gram stainers because they may produce discrepant culture and Gram stain results, potentially leading to misdiagnosis or improper patient treatment.
Varian Medical Systems is recalling Optical Surface Monitoring Systems (OSMS) used with TrueBeam EDGE because unintended changes to couch rotation parameters can occur during patient set-up.
Sorin Group USA is recalling Aortic Arch Cannulae because the distal tip angle is 15-20 degrees instead of the specified 45 degrees.
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, potentially leading to increased coil stretching.
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, increasing the risk of coil stretching.
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