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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.
Medline Industries is recalling certain Nurse Assist components used in Bronchoscopy Trays due to potential lack of sterility. Affected irrigation solutions and saline flush syringes may be non-sterile.
Vyaire Medical is recalling 106,656 units of AirLife Adult Manual Resuscitator bags due to faulty components that may break during use, causing ventilation failure and potentially leading to hypoxia or death.
Vyaire Medical is recalling 4,572 units of AirLife Adult Manual Resuscitators due to defective components that may cause improper ventilation or complete ventilation failure, potentially resulting in hypoventilation, hypoxia, or death.
Medline is recalling laceration trays and medical kits with approximately 12,000 units due to sterility defects in component solutions. Non-sterile medical devices could pose infection risk during wound care procedures.
Medline Industries recalls 5,969 surgical kits and trays that may lack sterility due to components from Nurse Assist. The non-sterile irrigation solutions could compromise product safety.
Medline Industries is recalling certain sterile medical kits and trays that contain component solutions with a potential lack of sterility. Non-sterile solutions could result in infection or contamination during medical procedures.
Medline Industries is recalling approximately 10,391 Centurion dialysis kits due to potential lack of sterility in Nurse Assist components. Products were distributed nationwide and in select international locations.
Medline Industries is recalling 14,234 units of Centurion surgical kits and trays that may contain non-sterile irrigation solutions. The affected products were manufactured using compromised Nurse Assist components.
Medline Industries is recalling circumcision surgical trays due to potential lack of sterility in component solutions. The recall affects 1260 units distributed across the US, Puerto Rico, Canada, UAE, and Panama.
Vyaire Medical is recalling 3,636 AirLife Adult Manual Resuscitator kits. Manufacturing defects can cause component failure that prevents proper ventilation, potentially resulting in fatal hypoxia.
Medline is recalling serum tear kit irrigation solutions due to potential sterility defects. The solutions may not be sterile, posing contamination risks during medical use.
Medtronic is recalling its Duet External Drainage and Monitoring System due to potential catheter disconnection from patient line stopcock connectors. This device is used to drain cerebrospinal fluid and reduce intracranial pressure.
Medline Industries is recalling 385,028 tracheostomy care trays due to potential sterility issues with certain components. The kits were distributed nationwide and internationally.
Medline Industries recalls certain surgical kits and trays because irrigation solution components may lack sterility, creating potential infection risk.
Vyaire Medical is recalling 66,078 units of AirLife Adult Manual Resuscitator oxygen tubing worldwide due to component manufacturing defects that can cause device failure and inadequate ventilation.
Medline is recalling surgical kits and trays with components that may lack sterility. The affected products were distributed nationwide and internationally.
Vyaire Medical recalls 3.6 million AirLife Adult Manual Resuscitators due to defective oxygen tubing components that may fail to deliver proper ventilation, risking hypoxia. Affected units were manufactured in 2017 or earlier.
Medline Industries is recalling Centurion Eye Prep Kits due to potential lack of sterility in irrigation solution components manufactured by Nurse Assist.
Medline Industries recalls multiple medical device kits and trays manufactured with components that may lack sterility. The affected solutions could be non-sterile, posing a potential safety risk.
The FDA is recalling USTAR II Knee System implants due to potential incorrect orientation of the curved stem. The defect may affect proper implant positioning in knee replacement surgery.
Integra LifeSciences is recalling the Cranial Access Kit due to a defect in sterile packaging that could compromise product sterility. The device is used for neurosurgical access to the brain.
Olympus is recalling 47 colonoscope units (Model PCF-H190DL) because they were assembled without protective adhesive. The missing adhesive may cause equipment failure under vibration, temperature changes, or shock.
The NxStage Cartridge Express dialysis device is recalled because blood can leak or spray from the arterial line. This could cause uncontrolled blood loss in patients or expose healthcare workers to infectious blood.
Integra LifeSciences is recalling 23 units of the Cranial Access Kit due to defects in sterile packaging that may compromise product sterility. Units were distributed worldwide.
Integra LifeSciences is recalling 1,324 cranial access kits due to sterile packaging defects that may compromise product sterility.
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