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.
Stryker GmbH is recalling two femoral nails that may have non-conforming cannulation, potentially leading to reduced strength and premature breakage.
Medtronic is recalling 8,821 EnTrust ICDs due to a potential loss of high voltage therapy near end-of-life. Patients should contact their healthcare provider.
Stryker GmbH is recalling specific femoral nails because non-conforming cannulation may reduce strength and cause premature breakage.
Stryker GmbH is recalling seven femoral nails because non-conforming cannulation may reduce strength and cause premature breakage.
Intuitive Surgical is recalling da Vinci Xi Stapler 45 Reloads because a missing knife mechanism component may prevent the device from cutting tissue.
Stryker GmbH is recalling specific femoral nails because non-conforming cannulation may reduce component strength and lead to premature breakage.
Stryker GmbH is recalling specific ankle arthrodesis nails because non-conforming cannulation may reduce strength and cause premature breakage.
Stryker GmbH is recalling specific femoral nails because non-conforming cannulation may reduce strength and cause premature breakage.
Roche Diagnostics is recalling the Elecsys Vitamin D total II test system because it may produce falsely elevated, non-reproducible results, potentially leading to incorrect vitamin D dosage adjustments.
Medtronic is recalling Percepta CRT-P MRI SureScan devices due to a potential device reset caused by a timing interaction between specific diagnostic and pacing features.
GE Medical Systems is recalling 102 Discovery IGS 730 Interventional Fluoroscopic X-ray Systems due to potential X-ray abort errors that may cause loss of imaging mode.
Intuitive Surgical is recalling da Vinci Xi Stapler 45 Reloads because a missing knife mechanism component may prevent the device from cutting tissue during surgery.
Medtronic is recalling 1,867 EnTrust Escudo ICDs because they may lose high-voltage therapy without a prior alert.
Immuno-Mycologics is recalling 875 units of Cryptococcal Antigen Lateral Flow Assay strips due to a defect that may cause false negative test results.
Medline Industries is recalling specific Bard MYPICC Kits because one case may not have been sterilized. The product was distributed to UT.
Medtronic is recalling Percepta CRT-P MRI SureScan devices due to a timing interaction that may cause a device reset.
Roche Diagnostics is recalling the Elecsys Vitamin D total II test system because it may produce falsely elevated and non-reproducible results, potentially leading to incorrect vitamin D dosage adjustments.
Medtronic is recalling 1,842 Percepta CRT-P MRI SureScan implantable pulse generators due to a potential device reset caused by a timing interaction between diagnostic and pacing features.
Stryker GmbH is recalling specific femoral nails because non-conforming cannulation may reduce component strength and cause premature breakage.
Stryker GmbH is recalling nine femoral nails because non-conforming cannulation may reduce component strength and cause premature breakage.
bioMerieux is recalling VIDAS analyzers and Quality Control VIDAS tests due to pump clogging and label displacement that may cause erroneous assay results.
Ion Beam Applications S.A. is recalling three Proteus 235 units because a software defect may cause patients to be treated in the wrong position.
Steris is recalling Reliance 1227 Washer/Disinfector units because the low chemical level alarm does not operate as intended, potentially preventing proper cleaning of patient care items.
Stryker Sustainability Solutions is recalling 2,722 reprocessed Coronary Sinus Diagnostic EP Catheters because thrombogenicity tests showed they did not meet non-thrombogenic specifications.
Fort Defiance Industries is recalling 199 P2131 Automated Field Steam Sterilizers because stagnant water and metal interactions can create deposits that interfere with the rear sight gauge or water liquid level switch.
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