Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Adjustable Gastric Band Recalled by Ethicon Endo-Surgery Inc Due to During aging studies, the firm determined that the...

Date: September 30, 2013
Company: Ethicon Endo-Surgery Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Ethicon Endo-Surgery Inc directly.

Affected Products

Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids, or in various kit configurations with one band per kit. Product Usage: Intended for use in surgical treatment of morbid obesity

Quantity: Product codes: RLZB22 - 2,352 units; RLZB22D1 - 968 units; RLZB22DG1 - 327 units; RLZB22DGT - 20 units; RLZB22DT - 48 units; RLZB22T - 0 units

Why Was This Recalled?

During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ethicon Endo-Surgery Inc

Ethicon Endo-Surgery Inc has 54 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report