FDA Medical devices recall ·
Contour Product Name: Contour Gold Eyelid Weight Model recall
- Recall number
- Z-1744-2025
- Date
- (initiated July 12, 2024)
- Company / brand
- Meddev Corp
730 N Pastoria Ave, Sunnyvale, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 34 weights
- Hazard tags
- Mislabeling
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3010 Product Description: Contour Gold Eyelid Weight, 1.0 gm MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted permanent lagophthalmos, usually resulting from facial paralysis.
Why was it recalled?
Due to mislabeling of products
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No LL3010; UDI code: 010081314202038217260727107227 Lot Number: 7227
Distribution
U.S. Nationwide distribution in the states of CA, CO, CT, FL, IA, IL, MA, ME, MI, NE, NY, OH, OK, OR, SC, TX, and WV.
States: California Colorado Connecticut Florida Iowa Illinois Massachusetts Maine Michigan Nebraska New York Ohio Oklahoma Oregon South Carolina Texas West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1744-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.