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
Read the official notice →- Date
- 2025-12-03
- Country
- United States
- Brand
- Alcon Research
- Product
- CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of PA, MN, CA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-05-06
US
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.
- 2025-12-31
US
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.
FDA · DeviceAlcon Research LLCUS Nationwide distribution in the states of CA, ND, UT.Official notice →- 2025-11-05
US
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 →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 →- 2025-03-12
US
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 →
Other drugs & medical recalls in the United States
- 2025-12-03
US
Magellan Diagnostics, Inc. recalls The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare¿ II…
Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low…
US
DERMASENSOR INC recalls DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on…
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
US
Straumann USA LLC recalls Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
FDA · DeviceStraumann USA LLCUS Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX,…Official notice →US
Medtronic Sofamor Danek USA Inc recalls Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT…
Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be…
FDA · DeviceMedtronic Sofamor Danek USA IncWorldwide distribution - US Nationwide and Puerto Rico. The countries of…Official notice →US
Olympus Corporation of the Americas recalls Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product…
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these…
US
Foundation Medicine, Inc. recalls FoundationOne CDx (F1CDx), RAL-0003 version 31.0
Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
FDA · DeviceFoundation Medicine, Inc.US Nationwide distribution to states of: AL, AZ, CA, FL, GA, IL, IN, KS, KY,…Official notice →