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.
Medline has recalled Centurion procedure packs containing syringes due to leaks, breakage, and quality issues. These defects may pose a risk to patient health.
Medline is recalling approximately 1.68 million medical convenience kits with plastic syringes affected by leaks and breakage. The defects may pose a risk to patient health per an FDA Safety Alert issued March 19, 2024.
Beaver Visitec International is recalling 227 units of BVI CustomEyes Procedure Packs containing syringes from Sol-Millennium Medical due to a quality concern affecting those syringes.
BVI CustomEyes Procedure Packs containing Sol-M manufactured low dead space and Luer Slip syringes are subject to a voluntary recall. Approximately 142 units were distributed nationwide.
A custom-made orthopedic surgical implant was supplied for a surgical procedure that did not match the design specifications. This mismatch could affect the proper fit and function of the device during surgery.
Medline Industries is recalling multiple procedural kits containing defective plastic syringes that may leak or break. The affected kits were distributed worldwide.
Medline Industries is recalling medical convenience kits containing plastic syringes due to quality issues including leaks and breakage that may pose a risk to patient health. The recall affects 1,679,067 units distributed worldwide.
Medline procedural kits contain plastic syringes affected by an FDA Safety Alert. The syringes may leak or break, posing risks to patients during medical procedures.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M-manufactured syringes. The recall affects 138 units distributed nationwide.
Medline is recalling procedural kits containing plastic syringes with leaks, breakage, and other quality defects. These defects may pose a risk to patient safety.
Medline Industries is recalling multiple Centurion procedure kit models due to plastic syringe defects including leaks and breakage that may pose a risk to patient safety. The affected kits were distributed worldwide.
Medline Industries recalled procedure packs containing Shenli syringes due to leaks, breakage, and quality defects. The recalled units were distributed worldwide and may pose a risk to patient health.
Multiple Medline procedural kits contain defective plastic syringes that may leak or break during medical procedures. The FDA has advised of potential patient health risks from these manufacturing quality issues.
Medline Industries recalls medical convenience kits containing plastic syringes due to leaks, breakage, and quality issues that may pose risks to patient health. About 1.6 million units were distributed worldwide.
GE Healthcare's Proteus XR/a stationary X-ray system lacks a required de-installation manual, creating risk of personnel injury during device removal.
Medline Industries is recalling Centurion procedure kits due to plastic syringes with defects including leaks and breakage. These defects may compromise patient safety during medical procedures.
Intuitive Surgical is recalling the Ion Endoluminal System due to potential screw failure in the instrument cart arm, which could cause uncontrolled catheter motion in patient airways.
Medline procedural kits containing defective plastic syringes have been recalled worldwide due to potential leaks and breakage. The affected products include ultrasound catheter insertion and circumcision kits distributed globally.
Medline is recalling Centurion procedure packs with plastic syringes that have leaks, breakage, and other quality issues. These defects may pose a risk to patient health.
Medline Industries is recalling multiple surgical procedural kits containing plastic syringes with quality defects. The syringes may leak or break during use, posing a risk to patient safety.
Medline procedural kits contain plastic syringes with leaks and breakage that may pose health risks. The affected kits are used for delivery procedures and distributed worldwide.
Medline is recalling Preop Nerve Block Tray kits worldwide due to plastic syringes with leaks, breakage, and quality defects. These defects were identified in an FDA safety alert and may pose risks to patient health.
Medline Industries recalls 1,679,067 medical convenience kits containing plastic syringes that may leak or break, posing potential risks to patient health.
Stryker is recalling iBur 4.0mm Coarse Diamond surgical burs that may overheat during use. Excessive heat could cause tissue or bone damage requiring medical intervention.
Medline recalls approximately 1.7 million procedure packs containing defective Shenli syringes due to leaks and breakage that may pose patient risks. The syringes are affected by an FDA Safety Alert from March 2024.
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