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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.
Cardinal Health's Presource Packs IV START KIT is being recalled due to a manufacturing defect in the connector that may cause fluid leaks and compromise intravenous fluid delivery.
Siemens Healthcare is recalling 1,865 Atellica IM Folate 700 diagnostic kits nationwide and internationally. The kits may produce inaccurate folate test results when whole blood calibration is used instead of serum calibration.
Medline is recalling sterile oncology port access trays in which some components were not properly sterilized due to improper placement during manufacturing. Healthcare facilities should immediately discontinue use of affected units.
Siemens Luminos Agile Max diagnostic imaging systems recalled due to default configuration parameters allowing collision with room structures, risking serious injury to staff or patients.
Siemens ADVIA Centaur Folate 100 test kits are recalled due to negative bias when whole blood calibration is used to test serum samples. The affected kits may produce falsely low folate results.
S & MOHR AMERICA recalled approximately 1,320 abm Respiratory Care Standard Breathing Circuits due to incorrect expiration dates printed on product labels. The manufacturing date was printed where the expiration date should appear.
Medline is recalling surgical convenience kits because the perforated bag does not maintain sterility of the kit's exterior wrapping. Only the contents inside the wrapping are sterile.
Medline is recalling 30 units of surgical angio port kits due to a perforated outer bag that prevents the external packaging from being sterile, creating a contamination risk during surgical use.
MEDLINE PAIN TRAY surgical convenience kits (120 units, Lot #22EBA798) are recalled nationwide because a perforated outer bag compromises the sterile barrier. Only the contents inside the kit's inner wrapping remain sterile.
Medline Industries is recalling 1,588 surgical kits nationwide due to a perforated bag design that prevents the outside of the kit wrapping from remaining sterile.
Medline Industries is recalling CENTURION MEDICAL PRODUCTS neonatal PICC surgical kits because the perforated bag fails to maintain sterility on the exterior packaging. Only contents inside are sterile.
Medline and Centurion Medical Products are recalling surgical convenience kits because the outer packaging has perforations that prevent sterility, leaving only the contents inside the kit wrapping sterile.
Medline Industries has recalled 120 units of Centurion Medical Products Tracheostomy Tray due to a perforated outer bag that prevents the exterior from remaining sterile, though the kit contents remain sterile.
Medline Industries recalls 1537 Lab Draw Kits (Reorder #DYNDH1641A, Lot 22HMH339) distributed nationwide due to a perforated outer bag that cannot maintain sterility, compromising the protective barrier.
Medline Industries is recalling 630 surgical convenience kits because the perforated bag design fails to maintain sterility of the outer wrapping, though internal contents remain sterile.
The SIEMENS Biograph mCT PET scanner has a potential issue with the locking mechanism that secures the gantry. Six units distributed worldwide including the US, Japan, Chile, and Australia are affected.
MEDLINE surgical convenience kits are recalled due to a perforated outer bag that prevents the kit's outer wrapping from remaining sterile. Only the contents inside the wrapper are guaranteed sterile.
Siemens is recalling the Biograph Horizon 3R Mobile PET/CT system due to a potential failure of the locking mechanism that secures the PET gantry in its scanning or service position. The system has been distributed worldwide.
Medline Industries is recalling 60 units of its Breast Biopsy Kit nationwide because the outer wrapping is not sterile. Only the kit's contents maintain sterility.
MicroPort Orthopedics is recalling lot 1916715 of EVOLUTION MP Tibial Bases (size 7) due to a packaging error where the wrong-sized implant component was found in a package. A confirmed incident involved discovery during surgery.
Select lots of HydroPICC 4Fr catheters are mislabeled with expiration dates that exceed their actual expiration. Affected units should not be used.
Medline Industries recalls CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAYS due to a perforated outer bag that fails to maintain sterility. While the inner contents remain sterile, the compromised outer bag could contaminate instruments during surgical procedures.
Medline is recalling 80 units of MEDLINE CABG PACK surgical convenience kits (Lot #22HMH432) nationwide because the perforated bag design cannot maintain sterility of the outer packaging wrapping.
Access Vascular is recalling select lots of HydroMID 4Fr catheters because they are labeled with incorrect expiration dates—the devices expire before the labeled dates. This creates a risk of using expired medical equipment in clinical settings.
Medline Industries is recalling 138 surgical convenience kits nationwide because the outer packaging does not maintain sterility. Only the contents inside the kit wrapper are sterile, creating a contamination risk.
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