Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 31, 2012
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.
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 administe…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ethicon, Inc. recalled EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. … - a moderate-severity action.
EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. … was recalled by Ethicon, Inc. in October 31, 2012. Reason: Ethicon and Omrix Biopharmaceuticals have received reports of air or gas embolism occuring in association wit…. Check the official notice for the remedy. Verify recall #Z-0111-2013 with the FDA Devices before acting.
The recall
Ethicon, Inc. issued this moderate-severity FDA Devices recall-Ethicon and Omrix Biopharmaceuticals have received reports of air or gas embolism occuring in association wit….
- Moderate
- severity level
- Class II
- classification
- October 31, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0111-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0111-2013) was formally reported on October 31, 2012, with the manufacturer initiating the action on July 2, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Ethicon, Inc. is listed as the recalling firm, operating out of Somerville, NJ. Federal records list the affected scope as 4800 pressure regulators distributed worldwide; 1500 distributed within the US.
The documented reason for this recall is: 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 rela… Distribution data in the federal record shows the product reached: Worldwide Distribution -- USA (nationwide) and the countries of Canada, European Union, Singapore, Israel, Mexico and Brazil.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
4800 pressure regulators distributed worldwide; 1500 distributed within the US
Related Recalls
6
3 from same agency
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.
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0111-2013 |
| Date reported | October 31, 2012 |
| Date initiated | July 2, 2012 |
| Recalling firm | Ethicon, Inc. |
| Firm location | Somerville, NJ |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0111-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ethicon, Inc.. Units affected: 4800 pressure regulators distributed worldwide; 1500 distributed within the US.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 31, 2012. Severity: Moderate. Recall number: Z-0111-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution -- USA (nationwide) and the countries of Canada, European Union, Singapore, Israel, Mexico and Brazil..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0111-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards
· 2026-07-02
CPSC Moderate
Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…
· 2026-06-25
CPSC Moderate
Arizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by…
· 2026-06-18
FDA Devices Moderate
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used i…
GE Medical Systems Information Technologies Inc · 2026-06-03
FDA Devices Critical
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit…
Medline Industries, LP · 2026-06-03
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 31, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.