The Recall Desk
ModerateFDA (Devices)·Z-1745-2025·Announced 2025-05-21

Meddev Contour Gold Eyelid Weight recalled for mislabeling

Meddev Corp is recalling 34 Contour Gold Eyelid Weight implants (Model LL3012, Lot 7228) due to mislabeling. The recall affects units distributed nationwide across 17 states.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II medical device with a mislabeling error. No reported injuries, illnesses, hospitalizations, or deaths are mentioned in the source. The hazard is limited to the labeling discrepancy with no described patient harm, consistent with the rubric's classification of minor labeling errors as Moderate severity.

Plain-English summary

Meddev Corp is recalling 34 Contour Gold Eyelid Weight implants, Model LL3012 (1.2 gm), Lot 7228, due to mislabeling of the products. The Contour Gold Eyelid Weight is a medical implant designed for the gravity-assisted treatment of permanent eyelid drooping (lagophthalmos), typically resulting from facial paralysis.

The recall was initiated due to mislabeling. The FDA has not provided specific details regarding the nature or consequences of the labeling error.

The affected units were distributed nationwide in the following states: California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maine, Michigan, Nebraska, New York, Ohio, Oklahoma, Oregon, South Carolina, Texas, and West Virginia. The unique device identifier (UDI) for the recalled product is 010081314202039917260727107228.

Patients, healthcare providers, and medical facilities that have received or use this device should contact Meddev Corp for further guidance. Healthcare facilities should quarantine remaining stock of this product pending resolution of the labeling issue.

The recalled product

Product
Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3012 Product Description: Contour Gold Eyelid Weight, 1.2 gm MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted permanent
Manufacturer
Meddev Corp
Category
Medical Device — Ophthalmic
Hazard
  • mislabeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Model No LL3012
  • UDI code: 010081314202039917260727107228 Lot Number: 7228

Distribution

Distributed nationwide across the United States.

Related recalls

Same category