Quick Facts at a Glance
- Recall Date
- December 18, 2025
- Hazard Level
- HIGH
- Brand
- Vascutek
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Vascutek
- Product type
- Gelatin-sealed vascular prostheses
- Model numbers
- 635024PE, 635024PE-B, 631514PE, 631514PE-B, 631222PE, 631222PE-B, 633008PE, 633008PE-B +47 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 18, 2025
Reported by FDA DEVICE
March 11, 2026
RecallRadar source check
March 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Vascutek, Ltd. or your healthcare provider for instructions. Notification method: Letter
About This Product
Gelsoft Plus and Gelweave vascular prostheses are implanted during vascular repair surgeries to replace or bypass diseased arteries.
Why This Is Dangerous
The expiry date was miscalculated because labeling relied on packaging rather than the gel impregnation manufacturing date. This could lead to use of expired devices or confusion about shelf life.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals must audit inventory and notify patients. Replacements or refunds may cause procedural delays. No injuries have been reported yet.
Practical Guidance
How to identify if yours is affected
- Identify Gelsoft Plus and Gelweave vascular prostheses in use at hospitals or clinics.
- Check device REF numbers listed in the recall notice.
- Verify expiry date against the gel impregnation manufacture date, not packaging date.
- Audit inventory to isolate affected devices.
Where to find product info
Expiry and manufacturing data are on device packaging and labeling; recall letters provide specifics.
What timeline to expect
Refund or replacement processing typically 4-8 weeks after notification.
If the manufacturer is unresponsive
- Escalate to hospital compliance or procurement personnel.
- Document all correspondence with the manufacturer.
- File a formal complaint with FDA recall authorities if needed.
How to prevent similar issues
- Verify expiry dates during procurement
- Keep recall contact information for suppliers
- Inspect packaging to ensure expiry reflects gel impregnation date
Documentation advice
Retain recall letter, packaging photos, model numbers, receipts, and all correspondence.
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Product Details
Gelsoft Plus devices with REF numbers including 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE among others. Gelweave devices include REF numbers such as 736038E, 736036E, 736034E, 736032E, 736030E, 736028E, 736026E, 736024E, 736022E, 736020E, 736018E, 736016E, 736014E, 736012E, 736010E, 736008E, 736006E, and related variants. Total quantity recalled: 37,430. Distribution: United States nationwide.
Key Facts
- Distribution: US nationwide
- Gelsoft Plus REFs include multiple models
- Gelweave REFs include multiple models
- Expiry mislabeling calculated from packaging, not manufacture
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Safety Guide
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