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.
LumiQuick Diagnostics is recalling Syphilis Test Cards because they were shipped to locations without required FDA clearances.
LumiQuick Diagnostics is recalling H. Pylori Ab Test Cards because they were shipped to locations without approved FDA applications.
LumiQuick Diagnostics is recalling Salmonella typhi IgG/IgM Duo Tests because they were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics is recalling Troponin I test cards because they were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics Inc. is recalling its Drugs of Abuse Panel Test Device because it was shipped to locations without required FDA approvals.
LumiQuick Diagnostics is recalling MDMA/Ecstasy test strips because they were shipped to locations without required FDA regulatory clearance.
LumiQuick Diagnostics is recalling all lots of its Ketamine Strip because the products were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics is recalling Buprenorphine Test Cards because they were shipped to locations without required FDA approvals.
LumiQuick Diagnostics Inc. is recalling Benzodiazepine Test Cards because they were shipped to US locations without approved FDA applications.
LumiQuick Diagnostics is recalling Cardiac Panel Tests because they were shipped to locations without required FDA approvals.
LumiQuick Diagnostics is recalling Cocaine Strips shipped to US locations without approved FDA applications.
LumiQuick Diagnostics is recalling H. Pylori Antigen Test Cards because they were shipped to locations without required FDA clearance.
LumiQuick Diagnostics is recalling Oxycodone Strips because they were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics is recalling Troponin I test cards because they were shipped to locations without required FDA clearance.
LumiQuick Diagnostics is recalling Malaria pf Antigen Test Cards because they were shipped to US locations without required FDA regulatory clearance.
LumiQuick Diagnostics is recalling PCP Test Cards because they were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics is recalling Propoxyphene Test Strips because they were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics Inc. is recalling Malaria pan Antigen Tests because they were shipped to US locations without approved PMA, IDE, or 510(k) clearance.
LumiQuick Diagnostics is recalling K2 Test Cards because they were shipped to locations without required FDA clearances.
LumiQuick Diagnostics is recalling Salmonella typhi/paratyphi Antigen Tests because they were shipped to locations without FDA approval.
Roche Diagnostics is recalling 76 Cobas c502 clinical chemistry analyzers because the Initial Cassette Volume Check feature fails to activate when specific reagent packs are loaded.
LumiQuick Diagnostics is recalling Methadone Test Strips because they were shipped to US locations without approved applications for PMA, IDE, or 510(k) clearance.
LumiQuick Diagnostics is recalling Barbiturate Test Cards because they were shipped to locations without required FDA clearance.
LumiQuick Diagnostics Inc. is recalling all lots of the Adenovirus Antigen Test Card because they were shipped to locations without approved FDA applications.
LumiQuick Diagnostics Inc. is recalling Buprenorphine Test Strips because they were shipped to locations without FDA approval.
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