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 1ml syringes manufactured by Sol-Millennium Medical, Inc., distributed nationwide in the United States.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes. The recall affects 98 units distributed nationwide.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes with low dead space and luer slip tip configurations. The product was distributed nationwide.
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 that contain Sol-M low dead space and luer slip syringes. The recall affects 150 units distributed nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain Sol-M syringes following the manufacturer's voluntary recall of these components.
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, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes. The affected units were distributed nationwide.
Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The affected syringes are low dead space and luer slip tip models distributed nationwide.
BVI is voluntarily recalling CustomEyes Procedure Packs that contain Sol-M manufactured syringes. The affected products were distributed nationwide in the United States.
The FDA is issuing a voluntary recall of BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes affecting 1,029 units distributed nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes due to a voluntary manufacturer recall. The affected packs were distributed nationwide in the U.S.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes (Part Number 58001331, Lot 6069181). The voluntary recall affects approximately 357 units distributed nationwide.
Beaver Visitec International is recalling 505 CustomEyes Procedure Packs containing Sol-Millennium Medical syringes that are subject to a voluntary manufacturer recall.
Beaver Visitec International is recalling 627 units of BVI CustomEyes Procedure Packs due to included Sol-M syringes subject to voluntary manufacturer recall.
BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes are being voluntarily recalled. The affected packs contain low dead space and luer slip tip 1ml syringes from Sol-Millennium Medical, Inc.
BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical are being voluntarily recalled. The affected products are distributed nationwide.
Beaver Visitec International recalls CustomEyes Procedure Packs because they contain Sol-Millennium Medical syringes subject to a voluntary recall. Fourteen units distributed nationwide.
Beaver Visitec International is voluntarily recalling 1,429 units of BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The packs were distributed nationwide.
Beaver Visitec is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes. Approximately 77 units were distributed nationwide.
Beaver Visitec International voluntarily recalls specific CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. No injuries or illnesses have been reported.
Neurovision Medical Products recalls Cobra 3-Plate EMG ET Tubes due to mislabeling with incorrect tube size on the label. The error could affect proper product selection in clinical procedures.
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.
BVI CustomEyes Procedure Packs containing Sol-M syringes are being recalled due to a voluntary manufacturer recall of the syringe components included in these procedure packs.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes due to a voluntary recall by the manufacturer. The procedure packs were distributed nationwide.
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