Z-1619-2018Class II

Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications...

Name: Z-1619-2018 Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications...
Creator: Boston Scientific Corporation
Published: 2018-02-12
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2018-02-12 / Terminated / root cause: design

FDA source

Boston Scientific Corporation began a recall of Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during open or endoscopic surgery to assist in the... on 2018-02-12. FDA classified it as Class II and gives the reason as "Potential for Capio sutures to break and /or detach". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1619-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-12
Posted: 2018-05-04
Terminated: 2020-04-10
Recalling firm: Boston Scientific Corporation
Product: Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.
Product code: PWI Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
Reason for recall: Potential for Capio sutures to break and /or detach.
Root cause tag: design
FDA root cause: Device Design
Action: Boston Scientific sent Urgent Medical Device Correction letters, dated February 12, 2018, to customers via FED-EX two day delivery. Customers were informed of the updates to the affected product instructions for use and advised to read the notification carefully and immediately post the information in a visible location near the product to ensure it is easily accessible to all users of the device. Also, the notification should be passed on to any health professional of the customer's organization that needs to be aware and to any organization where the potentially affected devices have been transferred. Customers with questions should contact their local BSC (Boston Scientific) Representative. **No product is being recalled and you are not required to return product to Boston Scientific** There is no impact to previously implanted mesh devices.
Quantity in commerce: 21,051
Distribution: Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.
Product codes and lots: UDI:08714729257615. Batch numbers: 17736884 18743137 19980158 17743915 18744758 20088658 17746353 18831921 20146415 17748695 18952185 20151917 17758603 18956329 20225741 17763024 18960345 20225743 17791930 19046994 20341445 17970678 19046996 20341447 18129693 19046998 20560166 18134147 19173285 20639024 18135271 19225756 20706637 18229178 19329479 20711254 18281817 19437996 20713128 18286295 19442739 20822293 18357019 19560316 20833214 18362244 19646043 20834317 18430411 19646222 20838382 18488288 19659042 21069563 18605754 19824767 21081751 18606004 19835267 21258659 18611631 19856248 21362105 19975069 21362107

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1619-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1616-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1617-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1618-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1619-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1620-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1621-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1622-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1623-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1624-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1625-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1626-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04

Product code PWI

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)