TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN): M00561411. Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.

Recall Insight

This FDA Devices action (record #Z-0720-2014) was formally reported on January 22, 2014, with the manufacturer initiating the action on November 20, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Boston Scientific Corporation is listed as the recalling firm, operating out of Marlborough, MA. Federal records indicate 425 eaches units are affected.

The documented reason for this recall is: Sterility of device may be compromised due to lack of pouch seal integrity Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.