Ethicon, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1996-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel. Indicated for use with manual compression as an adjunct to hemostasis for control of bleeding during adult liver surgery and soft tissue bleeding in adults when control of bleeding by standard surgical methods of hemostasis is ineffective or impractical.

Product Classification:

Class II

Date Initiated: April 11, 2016

Date Posted: June 22, 2016

Recall Number: Z-1996-2016

Event ID: 71372

Reason for Recall:

Ethicon is recalling EVARREST Fibrin Sealant Patch because the characters "0-bad" were printed in the expiration date field on the foil pouch labels of the Fibrin Patch units instead of the valid expiration date (2016-12-28).

Status: Terminated

Product Quantity: 228 units

Code Information:

Product Code #EVT5024, Lot #U01F012A

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated