Boston Scientific Recalls Capio SLIM Box 5 Sutures Due to Breakage Risk
Boston Scientific is recalling 60,538 units of Capio SLIM Box 5 sutures because they may break or detach during open surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (suture breakage/detachment) during surgery, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Boston Scientific Corporation is recalling 60,538 units of Capio SLIM Box 5 sutures, Model #M0068318261. These medical devices are intended for general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
The recall was initiated because there is a potential for the sutures to break and/or detach. The affected products were distributed worldwide, including in the United States and numerous other countries such as Brazil, Canada, Germany, and Japan. Specific batch numbers and the UDI 08714729842224 are listed in the official recall documentation.
Healthcare providers and patients should check their inventory and records for the affected model and batch numbers. If the product is in use or has been used, users should contact Boston Scientific for further instructions on how to proceed.
The recalled product
- Product
- Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 60,538
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 11 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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