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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.
Hillrom HScribe Holter System monitoring devices may assign duplicate file identifiers, risking patient identification mismatches in medical systems that use the identifier to match patient data to cardiac recordings.
The Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System may assign duplicate unique identifiers to exam files, potentially causing patient identification mismatches with their cardiac test data.
DeRoyal is recalling certain lots of children's surgical procedure packs due to reports that the included Stryker smoke evacuation pencil may activate without manual input or remain active after buttons are released.
The Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System may assign duplicate file identifiers that could cause patient data to be mismatched in DICOM archive systems.
DeRoyal is recalling surgical procedure pack products containing a Stryker SafeAir Smoke Evacuation Pencil that may activate without manual input or remain active after buttons are released. The malfunction poses a risk of injury during surgical procedures.
Ethicon is recalling Coated VICRYL surgical sutures due to needle pull-off and visual degradation. Lot QP2AJM, consisting of 31,032 units, was distributed to China.
Siemens recalled epoc BGEM BUN Test Cards for a negative sodium bias occurring approximately 2 months before expiration, with maximum observed bias of -10 mmol/L. No adverse events reported.
Hillrom diagnostic cardiology spirometer software may incorrectly assign duplicate identifiers to exam files, risking patient data mismatches. 1,369 units affected worldwide.
Hillrom Welch Allyn XScribe cardiac stress testing systems may assign duplicate exam identifiers, potentially causing patient data mismatches in medical record systems.
GE Healthcare's Centricity Universal Viewer Zero Footprint medical imaging software contains a security vulnerability that could allow unauthorized access and patient data manipulation. Approximately 120 units are affected worldwide.
Certain Hillrom Welch Allyn Vision Express Holter Analysis Systems may assign duplicate identifiers to cardiac exam files, risking mismatch between patient identities and their physiological data.
SHIMADZU CORPORATION's SONIALVISION G4 X-ray system may occasionally fail to display images when switching from fluoroscopy to radiography mode. This could result in examination delays or cancellations.
Nihon Kohden America Inc is recalling 17 Adult Cap-ONE Biteblock devices shipped after expiration dates. The single-use devices are intended for sampling CO2 and administering oxygen during endoscopy procedures.
27 Canon Cartesion Prime PET-CT imaging systems may experience software processing failures during simultaneous imaging of multiple patients, necessitating repeat examinations. The issue occurs when PET acquisition or reconstruction for another patient is performed while reconstruction is in progress.
Datascope Corp. is recalling 160 units of MEGA 7.5Fr intra-aortic balloon catheters due to discrepant labeling between inner and outer packaging, which could cause confusion about proper use.
Iotamotion Inc. is recalling the iotaSOFT Plus Drive Unit (Lot #D500330) due to an incorrect GTIN number on the product label. Five devices were distributed in Iowa.
Maquet Cardiovascular is recalling the VasoView HemoPro Endoscopic Vessel Harvesting System due to silicone detachment from the Harvesting Tool Jaws during use. This FDA Class I recall affects 28,809 units worldwide.
CADD-Solis battery packs used in ambulatory infusion systems may develop internal short circuits causing battery case melting and charging circuit failure. The FDA Class I recall affects 138,039 units worldwide.
GE Healthcare Giraffe Incubator Carestation CS1 units may release airborne formaldehyde residue during initial use. Manufacturer notified customers in June 2023 to run incubators for one week to off-gas any residual formaldehyde, which can cause eye irritation.
Percussionaire Corporation is recalling Phasitron5 breathing circuits (P5-10, P5-HC, P5-UC-10) due to discolored fluid caused by an unintended nickel coating on the spring component reacting with medicated mist. 43,830 devices have been distributed across the U.S.
Integra LifeSciences recalls 1,222 Surgical Patties and Strips (Model 801455) due to elevated endotoxin in raw material, which may contaminate finished products used to protect tissue during surgery.
Physio-Control is recalling 105 LIFEPAK 15 monitor/defibrillator systems due to a manufacturing defect caused by an out-of-tolerance tool used during assembly. Affected units were distributed in Connecticut, Georgia, Massachusetts, New York, Ohio, Washington, and West Virginia.
Codman Surgical Patties and Strips are being recalled due to higher-than-expected endotoxin levels in raw materials. Approximately 93,782 units were distributed worldwide for use in protecting tissue during surgery.
Abbott is recalling 13,318 units of its Alinity m HPV AMP Kit due to iron leaching into the lysis solution, causing positive controls to fail and potentially producing false negative test results.
Integra LifeSciences has recalled Codman surgical patties and strips due to higher-than-expected endotoxin levels in raw materials, which may result in out-of-specification endotoxin in finished products.
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