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.
Encore Medical is recalling the EMPOWR 3D Knee Tibial Insert due to a packaging error where hip and knee components were swapped, potentially causing surgeons to use the wrong implant during surgery.
Cardinal Health is recalling 13,351 procedure packs used in surgical procedures because they contain recalled components. The affected packs were distributed nationwide and in Canada.
The Medfusion Syringe Pump Model 3500-500 may experience force sensor calibration drift, causing false alarms or delayed occlusion detection. Approximately 20,815 units are being recalled worldwide, with increased risk in devices manufactured before April 2022.
RoyalVibe Health recalled multiple unapproved medical devices including ultrasound generators and therapy devices never FDA-authorized or cleared. Users could forgo legitimate medical treatment based on unproven marketing claims.
Olympus is recalling 2,496 units of THUNDERBEAT Model TB-0535FCS surgical instruments because the blue seal button may fail to return to neutral position after release, potentially causing prolonged surgery. The recall affects units distributed nationwide.
Cardinal Health is recalling 13,351 surgical procedure packs distributed nationwide and in Canada. The packs contain recalled equipment drapes, table covers, and surgical room turnover kits.
Ansell Healthcare Products LLC has recalled certain NOVAPLUS GAMMEX NON-LATEX PI GREEN surgical gloves because some sterile pouches were not completely sealed. Improper sealing could allow contamination before use.
Smiths Medical is recalling 118 units of Medfusion infusion pump plunger case components due to potential force sensor calibration drift. The sensor may malfunction, leading to delayed occlusion detection, false alarms, or system failure.
Cardinal Health is recalling Presource Fistulogram Packs containing recalled components including equipment drapes and table covers. Approximately 13,351 sterile packs distributed across 33 US states and Canada are affected.
TECHNO-PATH MANUFACTURING LTD. is recalling Multichem IA Plus and related controls due to broken glass vials that may expose laboratory personnel to biohazardous material. Affected lots should be discontinued immediately.
Smiths Medical Medfusion syringe pumps may have force sensors that drift out of calibration, causing delays in detecting line occlusions or triggering false alarms. Devices produced before April 2022 are at higher risk.
Cardinal Health is recalling surgical procedure packs that contain previously recalled components including equipment drapes, table covers, and surgical room turnover kits. Approximately 13,351 packs were distributed nationwide and in Canada.
Ansell is recalling GAMMEX NON-LATEX PI GREEN surgical gloves because some sterile pouches were not completely sealed. Approximately 1,511 units were distributed nationwide across multiple states.
The DxI 9000 Access Immunoassay Analyzer may mix up test results from different patient samples. A software defect causes the system to replace current sample barcodes with previously-used IDs, potentially associating wrong results with wrong patients.
Smiths Medical is recalling Medfusion Model 3500VX-500 Syringe Pumps due to force sensor calibration drift that can cause false alarms, system failures, or delayed occlusion detection.
TECHNO-PATH MANUFACTURING LTD. is recalling Multichem S Plus and related control vials due to a defect in the glass vial commodity. The vials may break during delivery, thawing, or opening, potentially exposing users to biohazardous material and delaying patient results.
Smiths Medical is recalling Medfusion Syringe Pumps due to force sensor calibration drift that may delay occlusion detection or trigger false alarms. About 67,507 pumps are affected, distributed in the US and Canada.
Reverse shoulder prosthesis packages labeled as containing 5mm x 30mm screws may instead contain incorrect 3.5mm x 30mm screws. Using the wrong size screws could cause surgical delay and inadequate fixation.
Certain BD Pyxis CII Safe ES software versions (1.7.3 and 1.7.4) can silently disable critical controlled substance tracking safeguards when multiple settings are updated at once, potentially allowing diversion. No incidents have been reported.
BD is recalling certain lots of BACTEC Plus Aerobic/F Culture Vials because some vials have duplicate barcode sequence numbers on their labels. The recall affects 781,600 vials distributed nationwide.
Cardinal Health is recalling 13,351 surgical procedure packs containing recalled components including equipment drapes, table covers, and surgical room turnover kits.
Cardinal Health is recalling 13,351 surgical procedure packs containing previously recalled components including equipment drapes, table covers, and surgical room turnover kits distributed nationwide in the US and Canada.
LivaNova recalls 37 units of the 3T Heater Cooler System due to incorrect maintenance schedule information in the Quick Reference Guide. No injuries reported.
Mazor Robotics has initiated a voluntary recall of 324 MAZOR X robotic guidance systems (Model TPL0059) due to a software issue requiring update. Affected devices were distributed nationwide in the US.
Cardinal Health is recalling 13,351 Presource PBDS surgical procedure packs (Lot #967679) containing defective equipment drapes, table covers, and surgical room turnover kits distributed nationwide and in Canada.
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