TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN):M00561420. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.

Reason: Sterility of device may be compromised due to lack of pouch seal integrity

Code information: Lot Numbers: H13061102, H13061103, H13061104, H13062401, H13062402, H13071302, H13082603

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.