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.
Robotic Uro/Gyn Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 372 units are affected.
DA VINCI PACK URO/PROSTATE medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 21 units affected.
BD Trucount Controls 30 Test kits are being recalled because they contain incorrect standard deviation values for the low and high control beads, which compromises accurate bead count calculation. 629 kits affected.
PACK GENERAL ROBOTIC medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 656 units are affected.
HVI Cardiac Robot Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 20 units are affected.
GS Endoscopy Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 816 units are affected.
BD Trucount Controls 30 Test kits, REF 664343, are being recalled because they contain incorrect standard deviation values for the low and high control beads. 10 kits are affected.
DAVINCI TRUCUSTOM BUNDLE medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 626 units are affected.
DAVINCI UROLOGY medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 166 units are affected.
GYN Robotic Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized in the kits, causing discoloration. 45 units affected.
A DxI 600 Access Immunoassay Analyzer is being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors that could delay patient results.
DxI 800 Access Immunoassay Analyzers with Spot B are being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors. 451 systems are affected.
Laparoscopic Tray medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 40 units are affected.
Laparoscopy Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 452 units are affected.
Cardiac Robot Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 20 units are affected.
Partial Nephrectomy Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 52 units are affected.
LAVH Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 292 units are affected.
Partial Nephrectomy - Robotic medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 46 units affected.
CT DAVINCI medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized in the kits, causing discoloration. 12 units are affected.
Laparoscopic Prostatectomy medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 30 units are affected.
UniCel DxI 800 Access Immunoassay Analyzers are being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors that could delay patient results. 2,203 systems affected.
Gen Laparoscopy Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 321 units are affected.
Laparoscopic GYN medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 18 units are affected.
General Laparoscopy Tray medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 574 units are affected.
T4 Total ELISA kits are being recalled because the expiration date on the kit box label and Certificate of Analysis exceeded the shelf life of the standards and control solutions by two months. 47 units affected.
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