Drugs & medicalClass I

Alcon Research LLC recalls Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04,…

Ophthalmic procedure packs may have incomplete seals affecting sterility.

Read the official notice →
Date
2025-12-31
Country
United States
Brand
Alcon Research
Product
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04,…
Classification
Class I
Units
US Nationwide distribution in the states of CA, ND, UT.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Alcon Research recalls

  1. 2026-05-06
  2. US
    Drugs & medicalClass II

    Alcon Research LLC recalls GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC:…

    Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

    FDA · DrugAlcon Research LLCNationwide within the United StatesOfficial notice →
  3. 2025-12-03
  4. US
    Drugs & medicalClass II

    Alcon Research LLC recalls CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+…

    XXX

    FDA · DeviceAlcon Research LLCWorldwide - US Nationwide distribution including in the states of PA, MN, CA,…Official notice →
  5. 2025-11-05
  6. US
    Drugs & medicalClass II

    Alcon Research LLC recalls Alcon PRECISION1 One-Day Contact Lenses, -2.25D.

    Potential for a weak seal in some units resulting in compromise in sterility.

    FDA · DeviceAlcon Research LLCWorldwide - US distribution in the states of Alabama, Arizona, Arkansas,…Official notice →
  7. US
    Drugs & medicalClass II

    Alcon Research LLC recalls Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number:…

    Due to incomplete seals in the pouch which provide the sterile barrier.

    FDA · DeviceAlcon Research LLCWorldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE,…Official notice →
  8. 2025-07-16
  9. US
    Drugs & medicalClass II

    Alcon Research LLC recalls Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See…

    Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable,…

    FDA · DeviceAlcon Research LLCWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice →
  10. 2025-03-12
  11. US
    Drugs & medicalClass II

    Alcon Research LLC recalls Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05,…

    Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch contains the symbol for a latex-free product. If users or…

    FDA · DeviceAlcon Research LLCUS Nationwide distribution in the states of AK, AR, AZ, FL, MD, MN, NC, NE,…Official notice →
All 22 Alcon Research recalls →

Other drugs & medical recalls in the United States

  1. 2025-12-31
  2. US
    Drugs & medicalClass II

    Intuitive Surgical, Inc. recalls da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40

    Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be…

    FDA · DeviceIntuitive Surgical, Inc.US Nationwide distribution in the states of MN, FL, CO, CA, NC, KS, TX, SC,…Official notice →
  3. US
    Drugs & medicalClass II

    Howmedica Osteonics Corp. recalls The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR)…

    When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.

    FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide and the countries of Canada, Germany,…Official notice →
  4. US
    Drugs & medicalClass II

    CareFusion 303, Inc. recalls BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis…

    Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to…

    FDA · DeviceCareFusion 303, Inc.Worldwide - US Nationwide distribution including in the states of CO, IN, OH,…Official notice →
  5. US
    Drugs & medicalClass I

    Draeger, Inc. recalls Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.

    A certain component of affected devices was not delivered within specification and contained impurities.

    FDA · DeviceDraeger, Inc.Worldwide - US Nationwide distribution in the states of AK, CA, FL, IA, KS,…Official notice →
  6. US
    Drugs & medicalClass II

    AGFA Healthcare Corp. recalls Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800

    It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.

    FDA · DeviceAGFA Healthcare Corp.U.S. Nationwide distribution.Official notice →
  7. US
    Drugs & medicalClass II

    Merck Sharp & Dohme LLC recalls Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: Merck Sharpe & Dohme LLC, Rahway, NJ…

    Presence of particulate matter: potential presence of metal particulates in the product.

    FDA · DrugMerck Sharp & Dohme LLCNationwide in the USAOfficial notice →
See all drugs & medical recalls →