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 specific Sol-M syringes due to a voluntary recall by the syringe manufacturer.
Beaver Visitec International has voluntarily recalled BVI CustomEyes Procedure Packs that contain Sol-Millennium Medical syringes following a concurrent recall of those syringes. The packs were distributed nationwide.
BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical are being voluntarily recalled. Approximately 43 units were distributed nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes that are subject to a voluntary manufacturer recall. Approximately 260 units are affected nationwide.
Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical low dead space and luer slip tip syringes. The recall affects 141 units distributed nationwide.
BVI is recalling CustomEyes Procedure Packs containing syringes from Sol-Millennium Medical due to Sol-M's voluntary recall of those syringes.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical, Inc., due to a voluntary recall of those syringes. The recall affects 154 units nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes in a voluntary manufacturer recall. 238 units 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 Sol-Millennium Medical syringes are being voluntarily recalled. Approximately 198 units were 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 International is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. No illnesses or injuries have been reported.
BVI CustomEyes Procedure Packs containing low dead space and luer slip syringes from Sol-Millennium Medical are being voluntarily recalled.
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.
BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical are being voluntarily recalled. The affected products are 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 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 containing Sol-M syringes manufactured by Sol-Millennium Medical. The voluntary recall affects 104 units distributed nationwide.
Beaver Visitec International is voluntarily recalling 4,301 units of BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes 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 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-M syringes. The voluntary recall affects 237 units distributed nationwide.
Beaver Visitec International is recalling 42 units of BVI CustomEyes Procedure Packs because they contain Sol-M syringes subject to a separate voluntary recall.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall of the syringe components.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall of the syringe components.
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