Vascutek Gelsoft Plus and Gelweave devices have incorrect shelf life labeling
Vascutek recalls Gelsoft Plus and Gelweave vascular repair devices that were incorrectly labeled with an additional month of shelf life. The device expiry should have been calculated from gel impregnation (date of manufacture) but was incorrectly calculated from device packaging.
Lower-risk recall
Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging.
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What happened, in plain English
Vascutek is recalling Gelsoft Plus and Gelweave vascular repair devices that were incorrectly labeled with an additional month of shelf life. The device expiry should have been calculated from the date of manufacture (gel impregnation) but was incorrectly calculated from the device packaging. This could lead to devices being used past their expiration date. Read more at govinfonow.com/recall/50399-vascutek-gelsoft-plus-and-gelweave-devices-have-incorrect-shelf-life.
Source Summary by GovInfoNow · govinfonow.com/recall/50399-vascutek-gelsoft-plus-and-gelweave-devices-have-incorrect-shelf-life · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1492-2026
Cite this page
“Vascutek Gelsoft Plus and Gelweave devices have incorrect shelf life labeling.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50399-vascutek-gelsoft-plus-and-gelweave-devices-have-incorrect-shelf-life. Based on FDA recall #Z-1492-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1492-2026%22&limit=1).
Why it’s dangerous
The devices were incorrectly labeled with an additional month of shelf life. The expiration date should have been calculated from the date of manufacture (gel impregnation) but was instead calculated from the device packaging. This could lead to devices being used past their expiration date.
Who’s affected
Patients who own or use these vascular repair devices are affected. The risk is low as the issue is a labeling error, not a safety hazard.
How to tell if you have this one
Check for Gelsoft Plus devices with item numbers ending in 'PE' or 'PE-B' (e.g., 635024PE, 635024PE-B) or Gelweave devices with item numbers ending in 'E' or 'E-B' (e.g., 736038E, 736038E-B).
- Brand
Vascutek- Category
Medical device
What to do — step by step
Check Device Label
Look for item numbers ending in 'PE' or 'PE-B' for Gelsoft Plus devices, or ending in 'E' or 'E-B' for Gelweave devices.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 50 states.
FDA distribution: “US Nationwide distribution including in the states of FL, PA, TX, NC, NY, CA, NJ, OH, MI, DC, CO, VA, GA, IL, OR, ND, VT, MS, MA, IN, WA, AZ, MN, MD, IA, OK, MO, AL, WI, LA, AR, TN, CT, ME, NE, SC, KS, NV, KY, RI, WV, UT, MT, ID, AK, NH,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-1492-2026 (December 18, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1492-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.