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.
Biomerieux Inc is recalling VIDAS Varicel Zoster IGG 60T (Catalog 30217, Batch 229478) due to storage temperature and time exceedance. The recalled units cannot be guaranteed to perform accurately.
Biomerieux is recalling ETEST Meropenem diagnostic tests because units experienced temperature and time storage excursions that may affect test accuracy. Affected lot 1009462290 was distributed nationwide.
Biomerieux Inc is recalling ETEST antibiotic susceptibility test strips due to storage temperature and time excursions that may affect test performance. No illnesses or injuries have been reported.
Randox Liquid Assayed Specific Protein Control Level 2 has lost potency in rheumatoid factor, causing laboratory quality control tests to fail and delaying patient test results.
Steris Corporation is recalling 338 boxes of VERIFY Dual Species Biological Indicators (Lot #230613) because some units fail to promote spore growth as intended, risking false-negative sterilization test results.
Biomerieux Inc is recalling the VITEK 2 REAGENT AST-GN81 Test Kit after storage conditions exceeded specified ranges, preventing guaranteed product performance. The recall affects 34 units distributed nationwide.
Biomerieux is recalling ETEST Clinical Ceftolozane/Tazobactam S30 diagnostic tests (batch 1009420460) due to storage temperature and time excursions. Product performance cannot be guaranteed, and test accuracy may be affected.
Biomerieux is recalling ETEST Clinical Tobramycin susceptibility test strips (batch 1009434160) because temperature and storage time conditions were exceeded during distribution. Product performance cannot be guaranteed due to these storage failures.
Biomerieux is recalling VIDAS LH 60 diagnostic test kits nationwide due to temperature and time excursion. The affected batch's product performance cannot be guaranteed due to storage conditions exceeding acceptable parameters.
Biomerieux is recalling VITEK 2 REAGENT AST-GN80 test kits due to temperature and time excursions during storage or handling. Product performance cannot be guaranteed for affected units.
Biomerieux Inc. is recalling 348 units of VITEK 2 Reagent GN Test Kit due to temperature and time storage parameter exceedance that may affect diagnostic performance. No illnesses reported.
Biomerieux Inc. is recalling VITEK 2 REAGENT AST-GN69 test kits nationwide due to temperature and time excursions during storage that may compromise product performance.
Biomerieux is recalling VIDAS RUB IGG diagnostic tests nationwide after storage temperature and duration exceeded specifications, affecting product performance guarantees.
Biomerieux Inc recalled ETEST antibiotic susceptibility test kits from batch 1009384490 due to storage conditions exceeding safe temperature and time parameters, potentially affecting test accuracy.
Biomerieux is recalling API Listeria detection test strips that were exposed to temperature and time exceedance during storage. Product performance cannot be guaranteed as a result.
Biomerieux is recalling TEMPO REAGENTS TEMPO CONTROL KIT (catalog 80000) due to storage conditions exceeding temperature and time limits, compromising product performance. Batch 1009477900 was distributed nationwide.
Biomerieux recalls VIDAS Listeria 60T test kits (Batch 1009371140) distributed nationwide because storage conditions were exceeded and product performance cannot be guaranteed. Users should discontinue use and contact the manufacturer.
Ortho-Clinical Diagnostics is recalling VITROS Intact PTH Reagent Packs due to negatively biased measurement results (average -12% shift). The affected reagent lots were distributed worldwide and may produce inaccurate patient test results.
Biomerieux is recalling 39 units of a diagnostic test kit because storage temperature and time parameters were exceeded, which may affect test performance and reliability.
Windstone Medical Packaging is recalling 9,489 custom surgical instrument kits that contain 3M Steri-Drape Surgical Drapes, which have been recalled by 3M Healthcare. Kits were distributed worldwide and in multiple U.S. states.
Biomerieux Inc is recalling PREVI COLOR GRAM diagnostic reagent (Catalog 29586) distributed nationwide because improper storage conditions may have degraded product performance.
Steris Corporation is recalling VERIFY Steam Test Pack biological indicators (lot #230613) due to inconsistent performance in promoting spore growth. When used to monitor sterilization, some indicators may not show growth even if the sterilization cycle was ineffective, creating false assurance of sterility.
DeRoyal is recalling certain Tonsillectomy Tray lots due to potential blockage of suction ports in the integrated electrosurgical suction coagulator. The defect may prevent proper suction function during surgical procedures.
Biomerieux Inc is recalling API 20 E 25 Strips (Batch 1009226560) because temperature and time excursions during storage exceeded specified parameters. Product performance cannot be guaranteed.
Biomerieux Inc. is recalling PPM CLINICAL CHROMID STREPTO B diagnostic media (batch 1009534170) because storage temperature and time exceeded specified limits, preventing assurance of product performance.
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