Agent, Absorbable Hemostatic, Non-collagen Based
General, Plastic Surgery · 21 CFR 878.4490
Recent MDR events
1,755 adverse event reports on file
- Arista AHJul 28, 2026InjuryDavol Inc., Sub. C.r. Bard, Inc. -12136431213643-2026-00960
- ETHICONJul 27, 2026InjuryEthicon Inc.2210968-2026-07455
- ETHICONJul 27, 2026InjuryEthicon Inc.2210968-2026-07457
- SURGICEL FIBRILLARJul 27, 2026MalfunctionEthicon Inc.2210968-2026-07487
- VERISETJul 21, 2026InjuryCovidien Surgical1219930-2026-04627
- VERISETJul 21, 2026InjuryCovidien Surgical1219930-2026-04628
- SURGICEL FIBRILLARJul 15, 2026InjuryEthicon Inc.2210968-2026-07241
- ARISTA AHJul 13, 2026InjuryDavol Inc., Sub. C.r. Bard, Inc. -12136431213643-2026-00905
- PERCLOTJul 2, 2026InjuryBaxter Healthcare Corporation1416980-2026-02223
- ETHICONJul 1, 2026InjuryEthicon Inc.2210968-2026-06933
Event type breakdown
Recalls
4 recall events for this product code
- GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Iron Deficiency Test (ferritin)
Distribution without premarket approval/clearance.
Z-0811-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Melatonin Test
Distribution without premarket approval/clearance.
Z-0812-2026 · View FDA record ↗ - Ethicon Sarl, a Johnson & Johnson CompanyOpen, ClassifiedJul 17, 2024
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961
Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
Z-2406-2024 · View FDA record ↗ - Ethicon Sarl, a Johnson & Johnson CompanyOpen, ClassifiedJul 17, 2024
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963
Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
Z-2407-2024 · View FDA record ↗
Registered firms
28 firms currently registered for this product code
Deroyal Industries, Inc.
POWELL, TN, US
Steris Isomedix Puerto Rico, Inc.
Alts De Cerro Gordo 3&4, PR, US
Burak Global Ic Ve Dis Tic Ltd Sti
Kocasinan Kayseri, TR
Ethicon, Llc.
San Lorenzo, PR, US
Synergy Health Ast, Llc
SAN DIEGO, CA, US
Baxter Healthcare Corporation
ROUND LAKE, IL, US
Medline Industries, Lp (northpoint Services)
Waukegan, IL, US
Isomedix Operations Inc.
Northborough, MA, US
Mka Medikal Ic Ve Dis Ticaret Sanayi Limited Sirketi
Cankaya Ankara, TR
Covidien
North Haven, CT, US
Davol Inc.
WOBURN, MA, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Artivion, Inc.
Kennesaw, GA, US
Clayens Fitchburg, Ma
Fitchburg, MA, US
Fedex Supply Chain, Inc.
Memphis, TN, US
Ethicon, Inc.
Raritan, NJ, US
Ethicon, Inc.
Somerville, NJ, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Mainline Medical Dental Supply
North York Ontario, CA
Davol Inc., Sub. C.r. Bard, Inc.
Warwick, RI, US
Pronorth Medical
ABBOTSFORD British Columbia, CA
Steris Schweiz Ag
Daniken Solothurn, CH
Isomedix Operations, Inc.
Libertyville, IL, US
Nas Med Llc Fz
DUBAI Dubayy, AE
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.