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 VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Zimmer Biomet is recalling 510 units of sterile-packaged VERSA-FX II STD TUBE implants because packaging design verification tests failed.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Philips is recalling DigitalDiagnost 3.1.x X-Ray Systems in the US due to a potential issue that may affect equipment performance under certain conditions.
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation and loss of potency.
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, leading to antibiotic degradation and loss of potency.
Zimmer Biomet is recalling sterile porous femoral stems because packaging design verification tests failed. The action affects units distributed worldwide.
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation and loss of potency.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, leading to antibiotic degradation.
Arrow International is recalling specific central venous access kits because packaging may not be completely sealed, potentially compromising sterility.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity may be compromised, potentially exposing the product to moisture and causing antibiotic degradation.
Biomerieux Inc is recalling VITEK 2 Anaerobic and Corynebacteria identification cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotic potency.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotic potency.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Biomerieux Inc is recalling VITEK 2 Gram Fungal Susceptibility cards because compromised container integrity may expose the product to moisture, leading to antibiotic degradation.
Zimmer Biomet is recalling sterile femoral intramedullary nails and accessories due to packaging design verification test failures.
Biomerieux is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may allow moisture exposure, potentially degrading antibiotic potency.
Biomerieux Inc is recalling VITEK 2 Fungal Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation and loss of potency.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may allow moisture exposure, leading to antibiotic degradation and loss of potency.
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity may be compromised, allowing moisture exposure that could degrade antibiotic potency.
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