The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

9876–9900 of 27206

  • ModerateFDA (Devices)·Z-2906-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M syringes recalled

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001712;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2897-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Voluntarily Recalled

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001637;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0648-2024·2024-09-04

    Cefixime oral suspension antibiotic recalled nationwide for subpotency

    Lupin Pharmaceuticals is recalling Cefixime 100 mg/5 mL oral suspension due to subpotency discovered during stability testing. The affected lot (F201517) was distributed nationwide.

    Product
    CEFIXIME — CEFIXIME (CEFIXIME)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2788-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Component Syringe Issue

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584643;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2846-2024·2024-09-04

    BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001123;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2843-2024·2024-09-04

    Syringes in BVI CustomEyes Procedure Packs Recalled Nationwide

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001110;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2925-2024·2024-09-04

    BVI CustomEyes Procedure Packs recalled due to incorrect syringes

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001933;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2917-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Recall

    Beaver Visitec International is recalling 236 units of BVI CustomEyes Procedure Packs containing syringes that have been voluntarily recalled by their manufacturer, Sol-M.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001825;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2904-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Subject to Voluntary Recall

    Beaver Visitec International is voluntarily recalling 200 units of BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001706;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2877-2024·2024-09-04

    BVI CustomEyes Procedure Packs Voluntary Recall for Sol-M Syringes

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001503;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2887-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled for Defective Syringes

    BVI is voluntarily recalling CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. A total of 97 units have been distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001602;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2802-2024·2024-09-04

    BVI CustomEyes Procedure Packs: Voluntary Recall of Sol-Millennium Medical Syringes

    BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical are being voluntarily recalled. Approximately 43 units were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000266;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2870-2024·2024-09-04

    BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled

    Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-M Inc. The recall affects 76 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001417;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2801-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Defective Sol-M Syringes Recalled Nationwide

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000195;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2883-2024·2024-09-04

    BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes in a voluntary manufacturer recall. 238 units were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001546;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2911-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Nationwide for Syringe Defects

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001764;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2862-2024·2024-09-04

    BVI CustomEyes Procedure Packs containing Sol-M syringes recalled

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001374;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2932-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001999;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2929-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled Nationwide

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001967;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2921-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled for Sol-M Syringe Components

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes. Approximately 79 units were distributed nationwide with no reported injuries.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001865;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2795-2024·2024-09-04

    Procedure packs with Sol-Millennium syringes subject to voluntary recall

    BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes are being voluntarily recalled. Approximately 198 units were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000056;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2928-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled for Defective Sol-M Syringes

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001944;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2852-2024·2024-09-04

    Medical Device Syringe Recall: BVI CustomEyes Procedure Packs

    BVI CustomEyes Procedure Packs containing Sol-M syringes are subject to a voluntary recall. The recall affects 148 units distributed in the US.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001200;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2831-2024·2024-09-04

    Voluntary Recall of BVI CustomEyes Procedure Packs with Sol-M Syringes

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000873;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2805-2024·2024-09-04

    BVI CustomEyes Procedure Packs containing recalled Sol-M syringes

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs because they contain syringes manufactured by Sol-Millennium Medical that are subject to a manufacturer's voluntary recall. 388 units were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000305;
    Category
    Medical Device
    Distribution
    Distributed nationwide