Z-0723-2014Class II

TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number...

Name: Z-0723-2014 TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number...
Creator: Boston Scientific Corporation
Published: 2013-11-20
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2013-11-20 / Terminated / root cause: packaging

FDA source

Boston Scientific Corporation began a recall of TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN):M00561421. Distributed by: Boston Scientific, Natick, MA... on 2013-11-20. FDA classified it as Class II and gives the reason as "Sterility of device may be compromised due to lack of pouch seal integrity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0723-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-20
Posted: 2014-01-11
Terminated: 2015-02-24
Recalling firm: Boston Scientific Corporation
Product: TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN):M00561421. 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.
Product code: FGX Snare, Non-Electrical
Reason for recall: Sterility of device may be compromised due to lack of pouch seal integrity
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Boston Scientific issued Customer Notification letters to US accounts via Federal Express Priority mail on November 20, 2013. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form.
Quantity in commerce: 620 eaches
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.
Product codes and lots: Lot Numbers: H13061102, H13061103, H13061104, H13062401, H13082603

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0723-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0719-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-11
Z-0720-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-11
Z-0721-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-11
Z-0722-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-11
Z-0723-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-11
Z-0724-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-11

Product code FGX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)