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 recalling BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall by the syringe manufacturer. The affected procedure packs were distributed nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical due to a supplier voluntary recall affecting 71 units nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain Sol-M syringes following the manufacturer's voluntary recall of these components.
BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes are being voluntarily recalled by the FDA. The affected 1ml Luer Lock and Luer Slip syringes were distributed nationwide.
Beaver Visitec International is voluntarily recalling 82 units of CustomEyes Procedure Packs containing Sol-M syringes due to a manufacturer recall. Affected lot numbers 6070885 and 6074819.
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 containing Sol-M syringes manufactured by Sol-Millennium Medical. The voluntary recall affects 104 units 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 because they contain defective syringes made by Sol-Millennium Medical. The voluntary recall affects 149 units distributed nationwide.
Beaver Visitec International voluntarily recalls 2,117 BVI CustomEyes Procedure Packs that contain Sol-M manufactured syringes. The syringes are part of a voluntary recall initiated by the syringe manufacturer.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical. The FDA has classified this as a Class II medical device recall.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical (Sol-M) syringes, affecting 126 units distributed nationwide. The recall was initiated following a manufacturer recall of the syringe components.
Beaver Visitec International is recalling 1,955 units of BVI CustomEyes Procedure Packs nationwide because they contain Sol-M syringes subject to a voluntary recall by the manufacturer.
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.
Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-M Inc. The recall affects 76 units distributed nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall by their manufacturer. Approximately 332 units were distributed nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip syringes due to a voluntary recall initiated by the syringe manufacturer. No illnesses or injuries have been reported.
BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes are being recalled in a voluntary action. 207 units with Part Number 58001999 are distributed nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical, Inc., subject to a voluntary recall by the manufacturer.
BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes are being voluntarily recalled. Approximately 198 units were distributed nationwide.
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 because they contain syringes manufactured by Sol-Millennium Medical instead of the intended product. The recall involves 57 units distributed nationwide.
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 Sol-M syringes are subject to a voluntary recall. The recall affects 45 units distributed nationwide.
BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical are being voluntarily recalled. Approximately 43 units were distributed nationwide.
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