Z-0111-2013Class II

EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba...

Name: Z-0111-2013 EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba...
Creator: Ethicon, Inc.
Published: 2012-07-02
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2012-07-02 / Terminated / root cause: manufacturing process

FDA source

Ethicon, Inc. began a recall of EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel... on 2012-07-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0111-2013
Classification: Class II
Status: Terminated
Initiated: 2012-07-02
Posted: 2012-10-22
Terminated: 2015-09-15
Recalling firm: Ethicon, Inc
Product: 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 code: FMF Syringe, Piston
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
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Ethicon sent a notification letter "Urgent Product Information EVICEL Fibrin Sealant (Human) All Lots and Product Codes" dated June 27, 2012, to all affected customers. Notifications were sent via UPS on July 2, 2012. The notification informed customers of the identified risks and included instructions for use. The notification included a business reply card consignees were requested to fill out and return. Customer were notified by a notification titled "Urgent Product Information Omrix Pressure Regulator All Product Codes" that was sent by Ethicon on August 1, 2012, as a follow up to the letter dated June 27, 2012. The notification informed consignees of the identified risks and included instructions for use. Customers were notified that a company representative would visit them to confirm receipt of the notification and to ensure the enclosed label has been affixed correctly on all Omrix Pressure Regulators. For further questions please call 1-877-384-4266.
Quantity in commerce: 4800 pressure regulators distributed worldwide; 1500 distributed within the US
Distribution: Worldwide Distribution -- USA (nationwide) and the countries of Canada, European Union, Singapore, Israel, Mexico and Brazil.
Product codes and lots: To include all lots and product codes for EVICEL and Omrix pressure regulators.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0111-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0111-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-22

Product code FMF

K090162Class IIEvicel Application DeviceOmrix Biopharmaceuticals , Ltd. / cleared 2009-02-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)