Z-0151-2014Class II

Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids

Name: Z-0151-2014 Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids
Creator: Ethicon Endo-Surgery Inc
Published: 2013-09-30
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2013-09-30 / Terminated

FDA source

Ethicon Endo-Surgery Inc began a recall of Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of... on 2013-09-30. FDA classified it as Class II and gives the reason as "During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0151-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-30
Posted: 2013-11-05
Terminated: 2014-03-26
Recalling firm: Ethicon Endo-Surgery Inc
Product: Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of morbid obesity
Product code: LTI Implant, Intragastric For Morbid Obesity
Reason for recall: During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.
FDA root cause: Unknown/Undetermined by firm
Action: Ethicon sent an Urgent: Medical Device Recall letter dated September 30, 2013 to affected consignees via overnight, UPS to allow tracking of the receipt. The letter identified affected products, problem and actions to be taken. Each consignee is requested to respond to a provided Business Reply Form (BRF), indicating whether they have affected product, how much and whether they will/have returned the product or whether they no longer have any of the recall product. For questions contact your local sales representative or call our Customer Support Center 1-877-384-4266 option 6.
Quantity in commerce: Product Code: BD2XV - 1,248 units
Distribution: Worldwide Distribution: USA (nationwide) including the states of: Alabama, Connecticut, Indiana, Michigan, North Carolina, South Carolina, Alaska, Delaware, Kansas, Minnesota, Ohio, Tennessee, Arizona, Florida, Kentucky, Mississipp,i Oklahoma, Texas, Arkansas, Georgia, Louisiana, Nebraska, Oregon, Virginia, California, Idaho, Maryland, Nevada, Pennsylvania, Washington, Colorado, Illinois, Massachusetts, New Jersey, Rhode Island, and West Virginia; and the countries of: Argentina, France, Malaysia, Spain, Australia, Georgia, Martinique, Sweden, Belgium, Germany, Mexico, Switzerland, Brazil, Greece, Netherland, Taiwan, Chile, Hungary, Panama, Tunisia, China, India, Philippines, United Arab Emirates, Czech Republic, Israel, Poland, United Kingdom, Egypt, Italy, Portugal, Venezuela, Estonia, Kenya, Russia, Finland, Kuwait, and Saudi Arabia.
Product codes and lots: The following product code and lot numbers were affected by this recall: Product Codes: BD2XV Lot Numbers: ZJMBB4, ZJMBN9, ZJNBBV, ZKDBM6, ZKDBM7, ZKFBDC, ZKGBDY, ZKHBBJ, ZKHBCR, ZKHBFG, ZKNBCK, ZKNBHC, ZLBBFK, ZLDBB8, ZLFBBC, ZLFBGG, ZLGBFV, ZLGBG5 , ZLJBCL, ZLMBBD, ZLMBYF, ZLNBCH, ZMBBGJ, ZMCBDL, ZMFBCT, ZMGBDF, ZMKBCG, ZNBBBB, and ZNCBBB.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0151-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0149-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-04
Z-0150-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-04
Z-0151-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-04

Product code LTI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)