Cardinal Health Prolene Polyproplyene Mesh, 3'' x 6'', Nonabsorbable Synthetic Surgical Mesh; six packages per box; sterile; product code PMII; Ethicon Inc., Somerville, NJ 08876 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Prolene Polyproplyene Mesh, 3'' x 6'', Nonabsorbable Synthetic Surgical Mesh; six packages per box; sterile; product code PMII; Ethicon Inc., Somerville, NJ 08876
Brand
Cardinal Health
Lot Codes / Batch Numbers
Catalog number PMII, lot numbers RBE609, expiration date 1/07, and RJJ130, regardless of lot number.
Products Sold
Catalog number PMII, lot numbers RBE609, expiration date 1/07, and RJJ130, expiration date 7/07 Note: any box with an orange dot on the end of the box is suspected counterfeit product, regardless of lot number.
Cardinal Health is recalling Prolene Polyproplyene Mesh, 3'' x 6'', Nonabsorbable Synthetic Surgical Mesh; six packages per box; due to Counterfeit mesh product labeled as Ethicon Prolene Polypropylene Mesh, product code PMII.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Counterfeit mesh product labeled as Ethicon Prolene Polypropylene Mesh, product code PMII.
Recommended Action
Per FDA guidance
Cardinal Health notified all of their hospital accounts who ordered catalog PMII by letter dated 11/3/03, alerting them to the two lots identifed as counterfeit and requesting the accounts to place all lots on hold in quarantine until further instructions are received. The accounts were requested to call Cardinal Health Customer Service at 800-964-5227 to arrange for product replacement. Cardinal Health customers were sent a follow-up letter dated 11/11/03 with product disposition information, instructing them to return all products bearing lot numbers RBE609 and RJJ130 and all boxes of Prolene with orange dots on the end of the box to Cardinal Health, and to closely examine any remaining boxes to the labeling posted on Ethicon''s website www.Ethicon.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026