Exact FDA event identifier

Event 66907

6 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: November 20, 2013
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Boston Scientific Corporation

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN): M00561410. 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.

Z-0719-2014

Recall number: Z-0719-2014
Initiated: November 20, 2013
Classification: Class II
Status: Terminated
Recalling firm: Boston Scientific Corporation
Quantity: 0 eaches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Numbers: H13061101, H13062403, H13062404, H13071301

Distribution pattern

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

device · product 2 of 6

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.

Z-0720-2014

Recall number: Z-0720-2014
Initiated: November 20, 2013
Classification: Class II
Status: Terminated
Recalling firm: Boston Scientific Corporation
Quantity: 425 eaches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Numbers: H13061101, H13062403, H13062404, H13071301

Distribution pattern

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

device · product 3 of 6

TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product Number (UPN):M00561412. 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.

Z-0721-2014

Recall number: Z-0721-2014
Initiated: November 20, 2013
Classification: Class II
Status: Terminated
Recalling firm: Boston Scientific Corporation
Quantity: 740 eaches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Numbers: H13061101, H13062403, H13062404, H13071301

Distribution pattern

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

device · product 4 of 6

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.

Z-0722-2014

Recall number: Z-0722-2014
Initiated: November 20, 2013
Classification: Class II
Status: Terminated
Recalling firm: Boston Scientific Corporation
Quantity: 253 eaches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

device · product 5 of 6

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.

Z-0723-2014

Recall number: Z-0723-2014
Initiated: November 20, 2013
Classification: Class II
Status: Terminated
Recalling firm: Boston Scientific Corporation
Quantity: 620 eaches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Numbers: H13061102, H13061103, H13061104, H13062401, H13082603

Distribution pattern

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

device · product 6 of 6

TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses. Universal Product Number (UPN):M00561422 Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica.

Z-0724-2014

Recall number: Z-0724-2014
Initiated: November 20, 2013
Classification: Class II
Status: Terminated
Recalling firm: Boston Scientific Corporation
Quantity: 3,300 eaches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Numbers: H13061102, 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.