Class II — Boston Scientific Corporation
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Registered facility | View this company's 37 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Sterility of device may be compromised due to lack of pouch seal integrity |
| Product | 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. |
| Quantity | 425 eaches |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands. |
| Initiated | 2013-11-20 |
| Classified | 2014-01-11 |
| Terminated | 2015-02-24 |
| Recall number | Z-0720-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Boston Scientific Corporation (Z-0720-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66907/
Alerts for Boston Scientific Corporation
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.