Use cautionMedical device recall · FDA · Published April 15, 2021
Boston Scientific Upsylon Y Mesh Kit Recall: Risk of Post-Op Infection
Boston Scientific recalls Upsylon Y Mesh Kit with Colpassist Vaginal Positioning Device due to potential pinholes causing sterile barrier breaches and post-operative infections. Affected lots listed; contact for return instructions.
Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection
Take action
Contact the company
📍Recalling firmBoston Scientific Corporation100 Boston Scientific Way · Marlborough, MA 01752-1234
✎ GovInfoNow plain-language explainer
Boston Scientific is recalling its Upsylon Y Mesh Kit with Colpassist Vaginal Positioning Device because pinholes on the pouch edge could compromise sterility, leading to infections after surgery. This affects specific product lots sold between certain dates. Read more at govinfonow.com/recall/62783-boston-scientific-upsylon-y-mesh-kit-recall-risk-of-post.
“Boston Scientific Upsylon Y Mesh Kit Recall: Risk of Post-Op Infection.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62783-boston-scientific-upsylon-y-mesh-kit-recall-risk-of-post. Based on FDA recall #Z-1491-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1491-2021%22&limit=1).
The FDA announced on April 15, 2021, that Boston Scientific Corporation is recalling the UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device due to potential pinholes in the pouch that may render the device non-sterile. The agency stated this breach could result in post-operative infection for patients.
How to tell if you have it
UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device
UPC: 08714729848103
Lot codes: C003726 through C004223 (all unexpired lots listed)
Material No. M0068318220
The hazard
The recall addresses the potential for pinholes on the edge of the pouch, which constitutes a sterile barrier breach. According to the FDA, this defect may render the device non-sterile and potentially result in a post-operative infection.
Context
GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Recent recalls include the Imager II Angiographic Catheters Recall (Aug. 24, 2026) for tip fracture risk and the LUX-Dx Cardiac Monitor System Recall (Aug. 6, 2026) for delayed AF burden alerts. Other recent recalls of similar products include the Intracept Access Instruments Recall (April 22, 2026) and the Vortex Surgical I2 Injection Kit Recall (Dec. 16, 2025).
How to tell if you have this one
Check for the product name 'Upsylon Y Mesh Kit with Colpassist Vaginal Positioning Device' and lot numbers listed in the recall (e.g., C003726, C003737). The kit is intended for pelvic floor surgery procedures.
Brand
Boston Scientific
Product
UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Algeria, Brazil, Colombia, Estonia, Germany, Hong Kong, Australia, Canada, Costa Rica, Finland, Great Britain, Italy, Austria, Chile, Czech Republic, France, Greece, Jordan, Belgium, Lebanon, Mauritius, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan.
Recall number
Product, codes & lots
Quantity
Z-1490-2021
Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210; All unexpired lots: C003699 C003715 C003735 C003750 C003775 C003804 C003813 C003842 C003853 C003887 C003905 C003936 C003950 C003960 C003966 C003986 C003997 C004028 C004041 C004078 C004091 C004107 C004117 C004128 C004136 C004160 C004186 C004206 C004221 GTIN 08714729848097
4,549 WW
Z-1491-2021
UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic or robotic approach Material No.M0068318220 Individually packaged Upsylon Y Mesh (UPN M0068318200) is not impacted by this removal. Note: The UpsylonTM Y Mesh Kit consists of UpsylonTM Y Mesh and ColpassistTM Vaginal Positioning Device packaged and sterilized separately and then combined into a kit carton. This removal does not affect the UpsylonTM Y Mesh component of the kit, however, since the Colpassist device component is impacted, the entire UpsylonTM Y Mesh kit is being removed.; All unexpired lots: C003726 C003737 C003739 C003752 C003767 C003778 C003782 C003791 C003814 C003818 C003831 C003845 C003846 C003874 C003875 C003898 C003899 C003921 C003942 C003954 C003970 C003988 C003989 C003999 C004000 C004011 C004012 C004031 C004032 C004033 C004048 C004049 C004084 C004085 C004086 C004097 C004098 C004099 C004120 C004132 C004143 C004150 C004159 C004175 C004176 C004196 C004205 C004213 C004218 C004223 GTIN: 08714729848103
8,524 WW
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Look for the lot numbers listed in the recall (e.g., C003726, C003737) on the packaging.
Contact Manufacturer
Reach out to Boston Scientific for instructions on returning the kit if you have the affected lot numbers.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Algeria, Brazil, Colombia, Estonia, Germany, Hong Kong, Australia, Canada, Costa Rica, Finland, Great Britain, Italy, Austria, Chile, Czech Republic, France, Greece,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 20 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1491-2021 (April 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1491-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.