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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.
Biomerieux Inc. is recalling PPM Lombard TSA culture medium nationwide due to storage temperature excursion. The product may not perform to specification.
Biomerieux Inc is recalling VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T nationwide due to storage temperature and time deviations that prevent performance guarantee. Batch 1009351560 is affected.
Biomerieux Inc is recalling VIDAS HCG 60 test kits because storage conditions were exceeded, which cannot guarantee product performance. No illnesses or injuries have been reported.
Biomerieux Inc is recalling diagnostic culture media because temperature and time storage conditions exceeded acceptable specifications, which means product performance cannot be guaranteed.
Biomerieux Inc is recalling PPM CLINICAL CHROMID MRSA 20 PLT diagnostic culture media (84 units) due to temperature and time exceedance during storage that may compromise product performance.
A batch of VITEK 2 Reagent BCL Test Kit from Biomerieux Inc is being recalled because storage conditions were exceeded, and product performance cannot be guaranteed.
Biomerieux is recalling PPM Clinical Craponne Chromid VRE culture media because storage conditions (temperature and time) exceeded specifications. Batch 1009540400 was distributed nationwide in the United States.
Biomerieux is recalling 6 units of ETEST Meropenem/Vaborbactam susceptibility test kits (Batch 1008848690) distributed nationwide because they were stored outside specified temperature and time ranges, preventing guarantee of product performance.
Biomerieux Inc is recalling ETEST Clinical Colistin diagnostic test products because storage conditions exceeded safe parameters, making product performance unreliable. Affected batches were distributed nationwide.
Beckman Coulter is recalling IRISpec glucose control due to intermittent false positive results when used with specific urine chemistry strips. The recall may affect laboratory test accuracy.
Biomerieux Inc is recalling PPM Lombard Products IRR Count-Tact 3P Agar because storage conditions exceeded acceptable temperature and time parameters, potentially compromising product performance.
Biomerieux Inc is recalling a batch of PPM Clinical CHROMID MRSA diagnostic medium (catalog 414524) after storage temperatures and timeframes exceeded specification, preventing performance guarantees.
Biomerieux is recalling VITEK MS-FA clinical reagent due to storage condition violations that degrade product performance. The recall affects 29 units distributed nationwide.
Biomerieux Inc is recalling CHROMID CARBA laboratory products nationwide because storage conditions exceeded acceptable temperature and time ranges. The company cannot guarantee product performance.
Biomerieux is recalling ETEST Clinical Ceftriaxone test strips nationwide because storage temperature and time conditions were exceeded, which may affect product analytical performance.
Biomerieux Inc is recalling VITEK 2 Reagent NH Test Kit units nationwide because they were stored outside proper temperature and time parameters. Product performance cannot be guaranteed.
Biomerieux Inc. is recalling 7 units of ETEST CLINICAL LEVOFLOXACIN LE 32 US S30 diagnostic test kits (Batch 1009240000) due to temperature and time storage condition violations that prevent guarantee of product performance.
Biomerieux is recalling BIOBALL B.SPIZIZENII NCTC 10400 (Catalog 56012) microbiological test cultures because storage temperature and time conditions were exceeded, and product performance cannot be guaranteed.
Biomerieux Inc. is recalling 310 units of the VITEK 2 REAGENT AST-GN79 TEST KIT (batches 5992201403 and 5992253503) nationwide because temperature and time conditions exceeded specified ranges, preventing guaranteed product performance.
Biomerieux Inc is recalling PPM Lombard Products TSA 3P W Neutralizers due to storage temperature and time excursions that degrade product performance. Affected units cannot guarantee reliable testing results.
Biomerieux Inc is recalling VIDAS Estradiol II 60 Tests (Catalog 30431-01, Batch 1009378680) distributed nationwide after temperature and time storage conditions were exceeded, potentially compromising test reliability.
Biomerieux Inc is recalling the BIOBALL P.AERUGINOSA NCTC 12924 quality control product due to temperature and time excursions that may affect product performance. Two units with batch number 7240 were distributed nationwide.
Biomerieux is recalling a C. difficile diagnostic test kit after units were stored outside temperature and time limits, potentially compromising test performance.
Biomerieux Inc. recalled 2 units of BIOBALL A.BRASILIENSIS NCPF 2275 reference standard (Batch 7112) after temperature and time storage conditions exceeded acceptable ranges. The manufacturer cannot guarantee product performance.
Biomerieux Inc has recalled the VITEK 2 Reagent AST-GP78 Test Kit nationwide due to temperature and time storage exceedances that may affect product performance. No illnesses or injuries have been reported.
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