Ethicon, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0111-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. Distributed by: Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. The Pressure Regulator System is positioned on the floor or on an IV pole and accepts medical gas (compressed air, nitrogen, CO2) from the central hospital system or from medical gas cylinders.

Product Classification:

Class II

Date Initiated: July 2, 2012

Date Posted: October 31, 2012

Recall Number: Z-0111-2013

Event ID: 63254

Reason for Recall:

Ethicon and Omrix Biopharmaceuticals have received reports of air or gas embolism occuring in association with the use of spray devices employing a pressure regulator to administer EVICEL; these events appear to be related to the use of the spray device at higher-than-recommended pressures and/or in close proximity to the tissue surface. The field correction initiated is to provide the recommend

Status: Terminated

Product Quantity: 4800 pressure regulators distributed worldwide; 1500 distributed within the US

Code Information:

To include all lots and product codes for EVICEL and Omrix pressure regulators.

Distribution Pattern:

Worldwide Distribution -- USA (nationwide) and the countries of Canada, European Union, Singapore, Israel, Mexico and Brazil.

Voluntary or Mandated:

Voluntary: Firm initiated