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.
Aesculap Implant Systems LLC is recalling the LEFT CORONAL BENDER (TEK1939) surgical instrument used in spinal procedures because it may deform implants when used with spinal system devices.
Hobbs Medical Polypectomy Snares (Catalog No. 7202) may accordion at the proximal end, preventing full closure and potentially causing injury. Specific lots distributed to medical facilities in NC, TX, WA, and Canada are affected.
GE Healthcare's SIGNA Premier MRI scanner is being recalled because under rare conditions, the gradient coils can produce elevated acoustic noise that could potentially cause hearing loss with prolonged exposure.
Certain Hill-Rom PRO+ MRS mattresses may have a Microclimate Management feature failure that increases patient pressure ulcer risk. Affected units were distributed to 25+ U.S. states and Canada.
Becton Dickinson is recalling BD Connecta Plus3 White Blend infusion connectors (Lot 1127328) due to potential stopcock leakage. The defect may interrupt treatment, expose patients to biohazardous material, or cause under-infusion.
Becton Dickinson recalls BD Connecta White 360 infusion connectors for potential leakage at the stopcock housing. The defect may interrupt treatment and expose patients to biohazardous materials.
A software error in SurgiCount+ System Application may allow duplicate surgical sponges to be counted without the required documentation prompt. This could allow surgical cases to close without proper verification that all sponges were accounted for.
Baxter Healthcare is recalling 404 Hill-Rom PRO+ 36" mattresses due to performance degradation in their heat and moisture management feature. This failure increases the risk of pressure ulcer development in patients.
Aesculap is recalling AESCULAP S4 Cervical Cross Connectors used in spinal fusion surgery due to insufficient clamping force that may cause the connectors to loosen or shift on the spinal rods.
Affected Hill-Rom Centrella Pro+ hospital mattresses can fail to properly manage heat and moisture removal, increasing the risk of pressure ulcer development in patients.
Siemens' Sensis diagnostic tool may lose communication and fail to display vital signs during initial patient exams or after inactivity. Software updates are required.
Randox Cholesterol diagnostic kits fail to meet stated performance specifications. Calibration issues cause quality control results to fall outside acceptable ranges, potentially delaying test results.
Aesculap Implant Systems is recalling the UR5 robotic arm component in its Aeos Digital Microscope System due to malfunction that prevents arm movement and requires system restart.
Boston Scientific is recalling GreenLight HPSEA Laser Fibers due to an incompatibility with the fiber card that causes an error message and requires equipment replacement during procedures.
Randox Laboratories is recalling Soluble Transferrin Receptors Calibrator kits used in lab analyzers. The calibrators can produce incorrect test results, with some values potentially underestimated by up to 30 percent.
Stryker Neurovascular is recalling 71 Trevo Trak 21 Microcatheter units because the product carton label is missing the required product drawing or illustration.
Xstrahl Limited is recalling specific lot codes of the X80 RADiant Photoelectric Therapy System due to a potential compatibility issue with replacement treatment applicators. Devices were distributed in Florida, California, and Kentucky.
Stryker is updating the Instructions for Use for the Triton Sponge System software (versions 4.6.5, 4.8.7, 4.9.6) to clarify proper handling technique for sponges and calibration placard. The FDA Class III recall affects 51 units distributed nationwide.
LumiraDx is recalling SARS-CoV-2 antibody quality control products because modifications to the test were made outside the scope of FDA-approved authorization. The recall affects 99 units distributed across 13 U.S. states.
Randox Laboratories is recalling Soluble Transferrin Receptor reagent (TF10159) due to calibration curve defects causing inaccurate test results on Siemens Atellica CH analyzers.
Synapse Biomedical revised labeling for the NeuRx Diaphragm Pacing System to clarify that temperature range symbols indicate storage conditions, not transport or package conditions. The revision affects 71 units distributed in the United States.
R & D Systems is replacing Instructions for Use (IFU) for Quantikine IVD Erythropoietin Human Serum Controls due to an incorrect CE marking designation that should not appear on the self-certified product.
Zeltiq Aesthetics is voluntarily recalling CoolCurve+ ZELTIQ Vacuum Applicators due to increased reports of Paradoxical Hyperplasia during 2019–2021, an adverse event involving abnormal fat growth at treatment sites.
Zeltiq Aesthetics is voluntarily discontinuing 2,945 CoolMax ZELTIQ Vacuum Applicators due to an increase in paradoxical hyperplasia complaints between 2019 and 2021, an adverse event causing unwanted tissue growth instead of intended fat reduction.
Alcon has recalled 320 kits of Custom Pak Surgical Procedure Packs distributed across Arizona, California, Missouri, and New York because they contain latex gloves instead of the specified non-latex gloves, creating an allergen hazard for sensitive patients.
Looking for a different category? Browse all recalls.