Adjustable Gastric Band — Class II medical device recall Z-0149-2014
Terminated recall by Ethicon Endo-Surgery Inc, reported 2013-11-13, distributed nationwide. During aging studies, the firm determined that the gastric belts were unable to pass the test requirements est
| Recall number | Z-0149-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon Endo-Surgery Inc, Cincinnati, OH, United States |
| Recall initiated | 2013-09-30 |
| Classified | 2013-11-04 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2014-03-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BE, BR, CH, CL, CN, CZ, DE, EE, EG, ES, FI, FR, GB, GR, HU, IL, IN, IT, KE, KW, MX, MY, PA, PH, PL, PT, RU, SA, SE, TN, TW, VE |
| Lot numbers | G4RE82, G4TA93, G4TC3R, G4TD5R, G4TF1X, G4TG22, G4TH90, G4TJ61, G4TK21, G4TL1D, G4TM3L, G4TM84, G4TP0W, G4TP6J, G4TR76, G4TT4D, G4TU2V, G4TV3T, G4TV48, G4TW6D, G4TX1V, G4U17U, G4U184, G4U323, G4U734, G4U75W, G4U795, G4UD6T, G4UD77, G4UD92, G4UF6Y, G4UF9V, G4UG4E, G4UH49, G4UH4K, G4UH6P, H43A3N, H43A3P, H43C8P, H43C8R and 73 more |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0149-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.