Implant, Intragastric For Morbid Obesity

ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110

ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak of distillation fluid during balloon inflation.

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.

Product was distributed past its expiration date.

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.

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

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

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

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

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

Lap-Band Access Port Needle 10-Pack, 20 G x 51 mm (2 in.), Product Code: 8-20302-10, Lot Number: 9L01N

The recall was initiated because Allergan has determined that a number of Access Port Needle pouches from one specific lot number may have small gaps in a pouch seal. Consequently the product may no longer be sterile.

LAP-BAND Adjustable Gastric Band System; Product codes:

In a LAP-BAND System adjustment, failure to inject the needle perpendicular to the access port septum, as described in Directions for Use, may lead to port damage, resulting in subsequent port leakage. Leakage results in deflation of the LAP-BAND to its widest, open position requiring a procedure to replace the port. The patient may have symptoms of reduced satiety and increased appetite. Stalling

REALIZE Adjustable Gastric Band, Injection Port and Applier

The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca

REALIZE Adjustable Gastric Band Pak with 15mm XCEL" trocar Product Code RLZB22T, Lot #: G4RE82

The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca

REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector Product Code RLZB22D1, Lot #: G4RJ90, G4RY0P, G4T15T, G4T289, G4T49Z, G4T52H, G4T861, G4TA93, G4TC

The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca