FDA Medical Device Recalls (openFDA)
Apollo Endosurgery Inc: LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.
- Recall number
- Z-2732-2014
- Recalling firm
- Apollo Endosurgery Inc
- Product
- LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.
- Status
- Terminated
- Initiated
- 2014-08-15
- Posted
- 2014-09-30
- Terminated
- 2016-02-01
- Reason
- Product was distributed past its expiration date.
- Root cause
- Software Manufacturing/Software Deployment
- Action
- Firm called its consignees and advised them to either return or destroy the devices which had not already been implanted.
- Quantity
- 10
- Distribution
- Distributed in the states of California, Delaware, Indiana, Missouri, New Jersey, New York, and Oregon.
- Lot, serial or model codes
- Lap-Band System AP Standard Catalog Number B-2240; Serial Numbers: 17760203, 17704664, 17704665, 17760205, 17760179, 17704672, 17704667, 17704659, 17760194, 17704653
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LTI
- Firm FEI
- 3006722112
- Firm city
- West Lake Hills
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28