Boston Scientific Corporation: Medical Device Recall in 2018 - (Recall #: Z-1620-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Capio Standard Box 4 (Capio PC); Model #M0068312321. 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 Classification:

Class II

Date Initiated: February 12, 2018

Date Posted: May 16, 2018

Recall Number: Z-1620-2018

Event ID: 79608

Reason for Recall:

Potential for Capio sutures to break and /or detach.

Status: Terminated

Product Quantity: 4,144

Code Information:

UDI:08714729257622 Batch numbers: 17817547 19050231 20639026 17925410 19225758 20717524 18139200 19335465 21081753 18363737 19437994 21258781 18615714 19698427 21386211 18826587 19983956 20341449 18955689 20341449

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated