Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 6
FDA device recall Z-1492-2026 · posted 2026-03-04 · Open, Classified
Recall details
- Recalling firm
- Vascutek, Ltd.
- Reason for 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.
- Action taken
- On 12/18/2025, Field Safety Notices were emailed to customers who were asked to do the following: Awareness of this Field Safety Notice is advised and shall be distributed to operating surgeons and users. The shelf life ranges (expiry dates) have now been corrected for all newly manufactured products. Please share this information with anyone in your organization who needs to be aware or is a user of the affected devices. Complete and return the Field Safety Notice Return Confirmation form to: taukfsn2025-003shelflife@terumoaortic.com Questions can be sent to the this email address as well.
- Root cause
- Error in labeling
- Status
- Open, Classified
- Product code
- DSY
- Quantity affected
- 37430
- 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
- Date initiated
- 2025-12-18
- Date posted
- 2026-03-04
- Location
- Inchinnan, United Kingdom
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Gelweave™ Vascular Prostheses (K241550) | Vascutek, Ltd. | 2025-02-27 |
| Gelsoft™ Plus Vascular Prostheses (K241070) | Vascutek, Ltd. | 2024-11-15 |