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…
Read the official notice →- Date
- 2025-03-12
- Country
- United States
- Brand
- Alcon Research
- Product
- 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,…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AK, AR, AZ, FL, MD, MN, NC, NE,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- 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
- 2025-11-05
USAlcon 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 →- US
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 → - 2025-07-16
- US
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 → - 2025-01-22
- US
Alcon Research LLC recalls Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D…
Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (IOL) upon delivery.
FDA · DeviceAlcon Research LLCUS: AK AL AR AZ CA CO CT DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO…Official notice → - US
- 2024-11-27
- US
Alcon Research LLC recalls a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon…
Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
FDA · DeviceAlcon Research LLCUS distribution to states of: Delaware, Illinois, and OklahomaOfficial notice →
Other drugs & medical recalls in the United States
- 2025-03-12
- US
Becton Dickinson & Co. recalls BD BBL TB Stain Kit K, Catalog (REF): 212522
One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025.
FDA · DeviceBecton Dickinson & Co.Domestic: AZ, CA, CO, GA, KY, IL, IN, NC, NJ, NY, MA, MD, TX, WA.…Official notice → - US
Integra LifeSciences Corp. recalls AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers…
Possibility for the obturator to break (separate).
FDA · DeviceIntegra LifeSciences Corp.US Nationwide distribution in the states of MO, FL, TX, NY, IL, OH, NJ, CA,…Official notice → - US
TAS Medical Inc recalls TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging zip-ties in 104-degrees F sterile saline solution for 60 min prior to…
- US
Murata Vios, Inc. recalls Vios Monitoring System Bedside Monitor Model BSM2050
Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Depleted batteries may lead to tablet connectivity issues.
FDA · DeviceMurata Vios, Inc.US Nationwide distribution in the states of Florida, Louisiana, Maryland,…Official notice → - US
DeRoyal Industries Inc recalls DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing,…
Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a…
- US
LUMENIS, LTD. recalls (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3)…
The initial current in certain chargers may lead to overheating and damage to the power resistors on the Alternating Current (AC) controller during the power-on sequence of the laser system, resulting in the laser…
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