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.
BVI is recalling CustomEyes Procedure Packs because they contain syringes subject to a separate voluntary recall by manufacturer Sol-Millennium Medical. The recall affects 217 units nationwide.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs that contain low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, Inc.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes manufactured by Sol-Millennium Medical, Inc. Approximately 70 units have been distributed nationwide.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing 1ml syringes manufactured by Sol-Millennium Medical, Inc., distributed nationwide in the United States.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes following a voluntary recall initiated by syringe manufacturer Sol-Millennium Medical (Sol-M), Inc.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, Inc. These packs were distributed nationwide.
BVI CustomEyes Procedure Packs containing syringes made by Sol-Millennium Medical (Sol-M) are being voluntarily recalled. These affected syringes are low dead space and luer slip tip 1ml models.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes as a voluntary Class II recall. The recall affects 103 units distributed nationwide.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs because they contain syringes manufactured by Sol-Millennium Medical that are subject to recall. The affected packs were distributed nationwide.
BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes are subject to a voluntary recall distributed nationwide. The recalled packs contain low dead space luer lock and luer slip 1ml syringes.
BVI voluntarily recalls CustomEyes Procedure Packs because they contain syringes recalled by their manufacturer, Sol-Millennium Medical, Inc. Approximately 94 units were distributed nationwide.
Beaver Visitec recalled BVI CustomEyes Procedure Packs containing Sol-M syringes in a voluntary recall. 19 units were distributed nationwide.
Beaver Visitec International is recalling CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip syringes due to a voluntary recall by the syringe manufacturer, Sol-Millennium Medical, Inc.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical, which are subject to a separate voluntary recall.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical, Inc. The recall affects 876 units distributed nationwide.
RONAN MEDICAL LLC is recalling BrainFeedback Pro 2 neurofeedback devices due to missing design and development documentation. Devices may not perform as intended.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical. The voluntary recall affects 29 units distributed nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall by the syringe manufacturer. The affected packs have been distributed nationwide.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes. Approximately 79 units were distributed nationwide with no reported injuries.
Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing Sol-M low dead space and luer slip tip syringes (Part Number 58001554) due to manufacturing concerns with the syringe components.
BVI CustomEyes Procedure Packs containing Sol-M syringes are being voluntarily recalled due to a defect in the syringes.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes. The recall affects 489 units distributed nationwide.
BVI CustomEyes Procedure Packs containing Sol-M syringes are subject to a voluntary recall. The recall affects 148 units distributed in the US.
Beaver Visitec is voluntarily recalling CustomEyes Procedure Packs containing syringes from Sol-Millennium Medical that were subject to a manufacturer recall. A total of 66 units were distributed nationwide.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-M. Approximately 1,338 units were distributed nationwide.
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