CLASS II ONGOING Device recall · Reported 21 May 2025 · FDA Enforcement Report

Contour Gold Eyelid Weight recalled by Meddev

Meddev is recalling Contour Gold Eyelid Weight, distributed nationwide in the US. The recall was initiated on 12 Jul 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No LL3010; UDI code: 010081314202038217260727107227 Lot Number: 7227

Quantity recalled34 weights

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1744-2025
FDA event ID: 96551
Recalling firm: Meddev, Sunnyvale, CA
Classification: Class II
Status: Ongoing
Recall initiated: 12 Jul 2024
FDA classified: 9 May 2025
Reported: 21 May 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

12 Jul 2024	Recall initiated by company
9 May 2025	Classified by FDA	+301 days
21 May 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to mislabeling of products

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide California Colorado Connecticut Florida Iowa Illinois Massachusetts Maine Michigan Nebraska New York Ohio Oklahoma Oregon South Carolina Texas West Virginia

Questions about this recall

Why was it recalled?

Due to mislabeling of products

Which lots are affected?

Model No LL3010; UDI code: 010081314202038217260727107227 Lot Number: 7227

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 96551

This product is part of a recall event; the main page for the event is Contour Gold Eyelid Weight recalled by Meddev.

Reported	Class	Recall	Company	Reason	Where
21 May 2025	CLASS II	Contour Gold Eyelid Weight recalled by Meddev	Meddev	Labeling Errors	Nationwide

More recalls from Meddev

All 2

Reported	Class	Recall	Company	Reason	Where
21 May 2025Device	CLASS II	Contour Gold Eyelid Weight recalled by Meddev	Meddev	Labeling Errors	Nationwide

Other Other Medical Devices recalls

All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide