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.
Surgical Specialties is recalling Sharpoint IQ Geometry Slit Knives because the tips may be bent. The recall affects 117,948 units distributed worldwide.
Spacelabs Healthcare is recalling 169 Xprezzon bedside monitor touchscreen displays because alarm lights may fail to illuminate upon installation.
Sunquest Information Systems is recalling 9 units of its Outbound Phlebotomy Point of Care Interface software due to confirmed reports of inappropriate patient order combination.
Medacta USA Inc is recalling 12 units of the Quadra S Offset Broach Handle because a rivet may become loose during surgery, preventing the locking mechanism from functioning.
Kimberly-Clark is recalling sterile surgical gowns because package seams may not remain sealed, potentially compromising sterility.
Surgical Specialties Puerto Rico Inc. is recalling Sharpoint IQ Geometry Slit Knives because the tips may be bent. The recall affects 117,948 units distributed worldwide.
Sechrist Industries is recalling 73 monoplace hyperbaric chambers to fix a software bug that could affect performance.
American Medical Systems is voluntarily recalling the AdVance Male Sling System because the resorbable suture may degrade before the 15-month shelf life expires.
Zimmer, Inc. is correcting patient labels for Dynesys Set Screws manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for Dynesys HA Pedicle screws manufactured before March 2010 due to reported discrepancies between product and patient labels.
Zimmer Inc. is correcting patient labels for MS-30 Sterile Shafts due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for NCB-PT tibial plates manufactured before March 2010 due to discrepancies in reference and lot numbers.
Alphatec Spine is recalling 11 units of the TI Standard Polyaxial Screw Assembly because they were laser marked with the incorrect length of 45 MM.
Sysmex America is recalling 1,099 XE-2100 Automated Hematology Systems because reticulocyte counts may be 21% lower than expected due to a low bias.
Zimmer Inc. is correcting patient labels for Dynesys Universal Spacers manufactured before March 2010 due to discrepancies in reference and lot numbers.
Shimadzu Medical Systems is recalling 133 mobile X-ray systems because certain units may not meet federal beam quality standards.
Surgical Specialties is recalling Sharpoint IQ Geometry Slit Knives because the tips may be bent. The recall affects 117,948 units distributed worldwide.
Shimadzu Medical Systems is recalling 3 mobile X-ray systems because they may not meet federal beam quality standards.
Zimmer Inc. is correcting patient labels for 209 Metasul Durom Femoral components after complaints of reference and lot number discrepancies.
Diagnostica Stago is recalling 237 STA Satellite Automated Multi-Parameter Analyzers because they may print incorrect INR values when using an external printer.
Zimmer, Inc. is correcting patient labels for Dynesys L.I.S. Stabilizing Cords manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for Anatomical Shoulder Humeral stems manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer, Inc. is correcting patient labels for Inverse/Reverse Screw systems manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for 74 anatomical shoulder humeral inserts manufactured before March 2010 due to reported discrepancies in reference and lot numbers.
Shimadzu is recalling 288 mobile X-ray systems and related components because they may not meet federal standards for beam quality.
Looking for a different category? Browse all recalls.