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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 Phosphate Buffer products due to temperature and time exposure during storage or transport that may have compromised product performance.
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 Inc is recalling PPM Clinical Chromid Candida diagnostic plates because storage temperature and time parameters were exceeded, preventing performance guarantees.
Biomerieux is recalling VIDAS Progesterone 60 diagnostic tests (Batch 1009375960) nationwide due to storage temperature and time conditions being exceeded, preventing guaranteed product performance.
Biomerieux recalled ETEST vancomycin susceptibility tests after storage temperature and time excursions that may compromise product reliability and test accuracy.
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 Inc. is recalling PPM Lombard culture medium because the product was exposed to temperature and time conditions outside specification, potentially affecting test performance.
Biomerieux Inc is recalling ETEST CLINICAL AMOXI/CLAV 2/1 XL test systems nationwide (batch 1009311920) due to temperature and time storage excursions that may affect product performance.
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 PPM INDUSTRY COMBOURG BACARA culture plates because they were exposed to improper storage temperatures and duration. Product performance cannot be guaranteed under these conditions.
Altimate Medical is recalling the ActiveAid 922 Shower/Commode Chair because a manufacturing defect prevents the frame from folding properly and being secured by the frame strap in the folded position.
Biomerieux Inc is recalling API VP1 VP2 reagents (Catalog 70422) nationwide because storage temperature and time limits were exceeded, preventing the manufacturer from guaranteeing product performance.
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 is recalling DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 reagent kits because temperature and time storage conditions were exceeded, preventing performance guarantees. Distributed nationwide, affected units should be removed from service.
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 Inc recalled 218 units of VITEK 2 AST-GP75 diagnostic test kits due to storage temperature and time violations that compromise test reliability. Affected facilities should stop using the recalled kits.
Detect Headquarters is recalling specific lots of Detect COVID-19 Test (Model 21205) due to risk of false negative results. Affected tests may fail to detect COVID-19 infection, potentially delaying treatment and increasing community spread.
Biomerieux Inc is recalling API JAMES 2AMP clinical diagnostic devices due to improper temperature and time storage conditions that may affect product performance. Affected units nationwide should not be used.
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.
The Guardian continuous glucose-monitoring app may automatically log out, preventing data uploads and SMS alerts to care partners. This could result in missed detection of dangerous blood sugar levels.
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.
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.
ENDO Pharmaceuticals is recalling 2,603 disposable trocars because packaging does not include printed expiration dates, creating risk of use of expired sterile devices.
Biomerieux Inc is recalling API 20 C AUX diagnostic strips due to storage conditions that exceeded temperature and time specifications. The manufacturer cannot guarantee product performance.
Biomerieux Inc. is recalling VITEK 2 REAGENT GP TEST KIT units nationwide due to temperature and time parameters exceeding acceptable ranges, which may affect test performance.
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