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.
Access Vitamin B12 Reagent lot 439850 is being recalled after complaints of erroneous results, which may lead to a delayed or improper diagnosis or repeat testing. 10,000 units are affected.
VITROS Chemistry Products Performance Verifier II is being recalled because quality control drift can occur with certain cholinesterase slide lots, which could produce erroneous patient results.
VITROS Chemistry Products CHE Slides supplied in Japan are being recalled because quality control drift can occur with certain Performance Verifier lots, which could produce erroneous patient results.
EMPOWR 3D Knee Tibial Insert E-PLUS units are being recalled because of a packaging discrepancy in which incorrect tibial inserts were packaged. 20 units are affected.
EMPOWR 3D Knee Tibial Insert E-PLUS units, catalog number 341-10-711, are being recalled because of a packaging discrepancy in which incorrect tibial inserts were packaged. 20 units affected.
VITROS Chemistry Products CHE Slides are being recalled because quality control drift can occur with certain Performance Verifier lots, which could produce erroneous patient results.
Medtronic SmartLink Software on the SmartSync Patient Connector is being updated because the system could display an erroneous electrical reset message on interrogation when no reset had occurred. 3,909 units affected.
NeuroSync EYE-SYNC systems containing Pico Neo 2 headsets are being recalled because eye syncing issues render the device inoperable and it cannot be repaired. 27 units are affected.
KWIK-STIK and LYFO DISK quality control kits for culture media are being recalled because affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. 21 units affected.
Medtronic SmartLink software on the CareLink SmartSync Device Manager is being updated because the system could display an erroneous electrical reset message on interrogation when no reset had occurred. 5,418 units affected.
The Bravo CF capsule delivery device is being recalled because misapplied adhesive may prevent the pH capsule attaching to the oesophagus or detaching from the delivery device. 128,202 units affected.
Edwards FEM-FLEX II Femoral Arterial Cannulas, model FEMII018AS, are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the cannula body. 558 units affected.
Edwards FEM-FLEX II Femoral Arterial Cannulas, model FEMII016A, are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the cannula body. 6,801 units affected.
Edwards FEM-FLEX II Femoral Arterial Cannulas, model FEMII018A, are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the cannula body. 13,240 units affected.
The Hillrom Q-Link 13 component used with mobile patient lifts is being recalled because it may allow false latching of the quick-release hook. 9,899 units are affected.
Edwards Optisite OPTI18 Arterial Cannulas are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the outside of the cannula body. 13,240 units affected.
Edwards FEM-FLEX II Femoral Arterial Cannulas are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the outside of the cannula body. 847 units affected.
Hillrom LikoScale components used with patient lift adapter kits are being recalled because the Q-link 13 may allow false latching of the quick-release hook. 9,839 units are affected.
Edwards Optisite OPTI16 Arterial Cannulas are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the outside of the cannula body. 27,022 units affected.
VersaCross Transseptal Sheath Kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.
Torflex Transseptal Guiding Sheath Kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.
Infinia, Infinia Hawkeye, Infinia II and Infinia II Hawkeye 4 nuclear medicine systems are being recalled because unintended radial detector motion may occur without the correct gantry software. 1,822 units affected.
VersaCross Access Solution kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.
The O-arm O2 Imaging System is being recalled because a mechanical component supporting the gantry to the support structure may have been damaged during manufacture. 3 units affected.
Varicam, Millennium VG, Millennium VG Hawkeye and Discovery VH nuclear medicine systems are being recalled because unintended radial detector motion may occur without the correct gantry software version. 21 units affected.
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