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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 is recalling a C. difficile diagnostic test kit after units were stored outside temperature and time limits, potentially compromising test 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.
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 BIOBALL B.SPIZIZENII NCTC 10400 (Catalog 56012) microbiological test cultures because storage temperature and time conditions were exceeded, and product performance cannot be guaranteed.
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 is recalling API NIT1 NIT2 Reagents (Catalog 70442, Batch 1009326520) distributed nationwide due to storage conditions that exceeded temperature and time parameters, preventing guaranteed product performance.
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 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 PPM Lombard R2A medium products (lot 1009527290) because storage conditions exceeded acceptable parameters, compromising product performance. Approximately 20 units distributed nationwide in the United States.
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 Inc recalls ETEST Clinical Benzylpenicil susceptibility test kits due to temperature and time excursions during storage that affect product performance. Batch 1009477980 was distributed nationwide.
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.
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 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 recalls GENE-UP Salmonella 2 reagent (Batch 1009407250) after storage temperature and time limits were exceeded, preventing performance guarantee.
Biomerieux Inc. is recalling ETEST Clinical Imipenem Relebactam test strips (Catalog 420927) distributed nationwide because the product experienced temperature and time excursions during storage. The manufacturer cannot guarantee the product's test performance.
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 API STAPH 25 diagnostic test kits because storage conditions exceeded safe temperature and time parameters. Product performance cannot be guaranteed for the affected batch.
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.
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 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 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 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 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.
Acumed LLC is recalling 7,498 units of Dual-Trak Clavicle Screws distributed worldwide without FDA pre-market clearance. These orthopedic surgical screws were marketed without required regulatory approval.
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