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.
Zimmer, Inc. is recalling 3,638 units of the Natural-Knee Flex System due to discoloration caused by premature oxidation during storage.
Ortho-Clinical Diagnostics is recalling VITROS White Correction Factor Slides because an incorrect assay value was printed on the carton, which may delay reporting of specific test results.
Zimmer, Inc. is recalling 3,638 Natural-Knee Congruent Tibial Inserts with Screws because a complaint identified discoloration caused by premature oxidation during storage.
Biomet 3i, LLC is recalling 704 units of Endobon Xenograft Granules 0.5 ML because individual pieces may have incorrect labels with the wrong batch number.
Biosense Webster is recalling PentaRay Nav and PentaRay Nav ECO catheters because the distal tip may separate from the shaft.
GE Healthcare is recalling Innova cardiovascular X-ray systems because they may unexpectedly stop delivering X-rays, causing a loss of real-time imaging.
Biomet 3i is recalling 170 Tapered Navigator Certain Surgical Kits because the trays failed to meet required sterility assurance levels during validation testing.
Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip. The sterile, single-use devices are distributed worldwide.
GE Healthcare is recalling Varicam and VG Hawkeye nuclear medicine devices due to a potential safety issue where the detector may drift toward the patient.
Maquet is recalling 1,424 Plegiox Cardioplegia Heat Exchangers because they may fail to reach the desired cardioplegia temperature when used with a heater/cooler unit.
Biomet 3i is recalling 541 Contra-Angle Torque Driver Kits because the trays failed to meet required sterility assurance levels during validation testing.
Smith & Nephew is recalling RENASYS-F XL with Soft Port dressing kits due to inadequate sealing that may prevent fluid evacuation and fail to trigger alarms.
Biomet 3i, LLC is recalling 21 units of the Navigator Surgical Kit because the trays failed to meet required sterility assurance levels during validation testing.
DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices due to potential holes in the sterile barrier pouches.
Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to an issue with the plunger tip. The devices are sterile, single-use diagnostic tools used for drawing arterial blood.
Smith & Nephew is recalling RENASYS-G Sterile Gauze Dressing Kits due to inadequate Soft Port sealing that may prevent fluid evacuation and fail to trigger alarms.
Smith & Nephew is recalling RENASYS-AB Abdominal Dressing Kits because inadequate sealing may prevent fluid evacuation and fail to trigger pump alarms.
Biomet 3i is recalling 181 dental torque driver kits because they failed to meet required sterility assurance levels during validation testing.
Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.
Smith & Nephew is recalling RENASYS Soft Port Dressing Kits because inadequate sealing may prevent wound fluid evacuation and fail to trigger pump alarms.
Horiba Medical is recalling ABX PENTRA ML software because a bug may transmit incorrect results to Laboratory Information Systems.
Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to an issue with the plunger tip. The devices are used for in-vitro diagnostic blood sampling.
Boston Scientific is recalling seven RunWay Guide Catheters because their sterile pouches may not be completely sealed, potentially compromising sterility.
Smith & Nephew is recalling RENASYS Gauze with Soft Port Kits because inadequate sealing can cause fluid to remain under the dressing and prevent the pump alarm from activating.
DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices because holes may develop in the sterile barrier pouches, potentially compromising sterility.
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