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.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-M. Approximately 1,338 units were distributed nationwide.
Beaver Visitec International is voluntarily recalling 133 units of BVI CustomEyes Procedure Packs containing Sol-M syringes manufactured by Sol-Millennium Medical. The Class II recall affects units distributed nationwide.
Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs (Part Number 58001306, Lot 6072093) containing Sol-M manufactured syringes. The recall affects 206 units distributed nationwide due to a voluntary recall by the syringe manufacturer.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M low dead space and luer slip tip syringes (Part Number 584545) nationwide. The recall is voluntary.
The FDA is recalling BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip syringes under a voluntary recall from the syringe manufacturer affecting nationwide distribution.
BVI is voluntarily recalling CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. A total of 97 units have been 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 International recalls BVI CustomEyes Procedure Packs nationwide due to the inclusion of syringes manufactured by Sol-Millennium Medical that are subject to a voluntary manufacturer recall.
Beaver Visitec International has recalled 115 units of BVI CustomEyes Procedure Packs containing Sol-M syringes distributed nationwide. The voluntary recall addresses a manufacturing issue with the syringes included in the procedure packs.
BVI CustomEyes Procedure Packs containing Sol-M syringes have been voluntarily recalled. The recall involves 315 units distributed nationwide.
Beaver Visitec International is recalling 214 BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall of the syringe components.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes. The recall affects 478 units distributed nationwide.
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.
BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes have been voluntarily recalled. The recall affects 124 units distributed nationwide.
Beaver Visitec International is recalling 236 units of BVI CustomEyes Procedure Packs containing syringes that have been voluntarily recalled by their manufacturer, Sol-M.
Beaver Visitec International is recalling 1,238 units of BVI CustomEyes Procedure Packs containing Sol-M syringes. The recall is voluntary and affects procedure packs distributed nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs because they contain syringes manufactured by Sol-Millennium Medical instead of the intended product. The recall involves 57 units distributed nationwide.
The FDA has issued a voluntary recall of BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes. Approximately 8 units have been distributed nationwide.
Beaver Visitec recalls BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes subject to manufacturing defect concerns. 17 units distributed nationwide.
BVI CustomEyes Procedure Packs containing Sol-M syringes have been voluntarily recalled. Users of affected packs should discontinue use and contact the manufacturer.
Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs (Part Number 58000594, Lot 6073112) containing Sol-M manufactured 1 milliliter syringes due to a recall of those syringes by their manufacturer.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs nationwide because they contain low dead space and luer slip syringes manufactured by Sol-Millennium Medical that are subject to a voluntary recall.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes. Approximately 79 units were distributed nationwide with no reported injuries.
BVI CustomEyes Procedure Packs are being recalled because they contain Sol-Millennium Medical syringes that were voluntarily recalled by the manufacturer. The affected packs were distributed nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain Sol-M syringes due to a manufacturer's voluntary recall. The nationwide recall affects Luer Lock and Luer Slip 1ml syringes in the procedure packs.
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