Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures
Riverpoint Medical is recalling 1,266 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. The defect could compromise the sterile field and increase the risk of surgical site infections.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of surgical site infection, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for hospitalization or significant injury).
Plain-English summary
Riverpoint Medical, LLC is recalling 1,266 units of Velosorb Fast Braided Absorbable Sutures, specifically the 3/0 Undyed 18" P-12 Cutting variety (Lot Number: 20060929FX). The product was distributed nationwide in the United States. The recall is classified as Class II by the FDA.
The recall is being issued because the surgical sutures are non-sterile. The use of these non-sterile sutures could compromise the sterile field during surgery, which increases the risk of a surgical site infection. The source text also notes that the defect may increase break strength retention.
Healthcare facilities and consumers who have this specific lot of sutures should stop using them immediately. They should contact Riverpoint Medical for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-12 Cutting SV497G, UDI: 20884521149707 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in…
- Manufacturer
- Riverpoint Medical, LLC
- Hazard
- Affected units
- 1,266
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 20060929FX
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 40 recalled by Riverpoint Medical, LLC 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 40 products in this recall →Related recalls
Same manufacturer · Riverpoint Medical, LLC
See all →- HighIconix Knotless 1.4mm Anchor recalled due to inserter failure risk
FDA (Devices) · 2023-12-20
- HighRiverpoint Medical Recalls Velosorb Fast Sutures Due to Tensile Strength Defect
FDA (Devices) · 2021-02-10
- HighRiverpoint Recalls Non-Sterile Velosorb Surgical Sutures
FDA (Devices) · 2020-10-07
- HighRiverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures
FDA (Devices) · 2020-10-07
- HighRiverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures
FDA (Devices) · 2020-10-07
Same hazard · infection
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
Similar recalls
- HighRiverpoint Medical Recalls Velosorb Fast Sutures Due to Tensile Strength Defect
FDA (Devices) · 2021-02-10
- ModeratePolysorb Suture Recalled for Potential Packaging Integrity Issues
FDA (Devices) · 2020-02-26
- HighFDA Recalls Polysorb Sutures Due to Packaging Integrity Issues
FDA (Devices) · 2020-02-26
- ModerateFDA Recalls Polysorb Sutures Due to Potential Sterility Barrier Issues
FDA (Devices) · 2020-02-26
- ModerateRecall of Polysorb Sutures Due to Potential Packaging Integrity Issues
FDA (Devices) · 2020-02-26
- ModeratePolysorb Braided Absorbable Suture Recalled for Packaging Integrity Issues
FDA (Devices) · 2020-02-26