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 container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Zimmer Biomet is recalling 87 units of sterile implants because packaging design verification tests failed. The action covers domestic and international distribution.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may expose the product to moisture, potentially degrading antibiotic potency.
Biomerieux is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity issues may allow moisture exposure, leading to antibiotic degradation and loss of potency.
Zimmer Biomet is recalling sterile intramedullary nail implants because packaging design verification tests failed. The action affects 9,867 units distributed worldwide.
Cook Inc. is recalling 178 Clarke-Reich Laparoscopic Knot Pushers because the reprocessing instructions do not provide sufficient detail for cleaning, disinfection, and sterilization.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially degrading antibiotic potency.
Biomerieux Inc is recalling VITEK 2 Gram Positive 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 container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Cook Inc. is voluntarily recalling Vue Optic Visualization Sources and Flexor Vue Deflecting Endoscopic Systems because current reprocessing instructions lack sufficient detail for cleaning and sterilization.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards due to potential container integrity issues that may expose the product to moisture and cause antibiotic degradation.
Zimmer Biomet is recalling sterile intramedullary nail implants and accessories 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 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 Negative 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 container integrity issues may expose the product to moisture, potentially degrading antibiotic potency.
Biomerieux Inc is recalling VITEK 2 Gram-Positive identification cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised containers 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.
Zimmer Biomet is recalling sterile intramedullary rod implants and accessories because packaging design verification tests failed. The recall affects 9,867 units distributed worldwide.
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.
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may expose the product to moisture, potentially degrading antibiotic potency.
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.
Acumedia Manufacturers, Inc. is recalling Palcam Supplement (PN 7987) due to possible contamination with Bacillus spp. The product is used for Listeria enrichment.
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