Boston Scientific Recalls Capio CL Sutures Due to Breakage Risk
Boston Scientific is recalling 1,258 Capio CL sutures because they may break or detach during transvaginal procedures.
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, and the hazard involves a risk of harm (suture breakage/detachment) in a medical procedure, which aligns with the 'High' severity criteria for risk-of-harm products where specific injury reports are not detailed in the source text.
Plain-English summary
Boston Scientific Corporation is recalling 1,258 units of the Capio CL suture device, Model #M0068311350. This medical device is indicated for the placement of suture in a variety of transvaginal procedures. The recall is being conducted because of 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. Specific batch numbers associated with this recall include 18011270, 18245411, 19491588, 18011271, 18654941, 19668541, 18229999, 18881759, 19987267, 20602764, 19173286, 20382965, 20850569, and 21234964. The UDI for the product is 08714729516545.
Healthcare providers and patients should check their inventory and records for these specific model and batch numbers. If the device is found, it should be removed from use and returned to Boston Scientific Corporation in accordance with their instructions.
The recalled product
- Product
- Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 1,258
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.
See all 11 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Same hazard · device failure
See all →- HighStryker Recalls XCEL Bladeless Trocar Due to Cracking Risk
FDA (Devices) · 2026-09-23
- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
Similar recalls
- HighBoston Scientific Capio SLIM Device May Fail During Surgical Procedures
FDA (Devices) · 2024-08-07
- HighCapio SLIM Suture Capturing Device may fail to catch sutures consistently
FDA (Devices) · 2024-08-07
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls Colpassist Vaginal Positioning Device Due to Sterility Risk
FDA (Devices) · 2021-05-05
- HighBoston Scientific Recalls Contour VL Ureteral Stent Sets
FDA (Devices) · 2020-04-29