TWISTER PLUS 26mm Rotatable Retrieval Device — Class II medical device recall Z-0722-2014
Terminated recall by Boston Scientific Corporation, reported 2014-01-22, distributed nationwide. Sterility of device may be compromised due to lack of pouch seal integrity
| Recall number | Z-0722-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2013-11-20 |
| Classified | 2014-01-11 |
| Reported by FDA | 2014-01-22 |
| Terminated | 2015-02-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, CH, DK, ES, FR, IT, NL, NZ, PT |
| Quantity | 253 eaches |
| Reason classes | sterility, packaging |
| Lot numbers | H13061102, H13061103, H13061104, H13062401, H13062402, H13071302, H13082603 |
Product
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 for recall
Sterility of device may be compromised due to lack of pouch seal integrity
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0722-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.