Edge Biologicals Inc recalls Edge Biologicals STERILE WATER

Due to product outer packaging incorrectly labeled.

On 10/02/2023, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that Edge Biologicals, Inc. is voluntarily recalling Sterile Water, Catalogue Number T-0780, Lot # 01223 due to the product being mislabeled as T-0627 Sterile Saline 85%. Customers are instructed to located any affected products, stop use and quarantine products until it is able to be returned to Edge Biologics, Inc. Use the following procedures to obtain a Return Merchandise Authorization (RMA): -Send a request per communication to qc@edgebiological.com titled: RMA requested for 1049818/10022023/R1 -Call 901-523-0034 and request an RMA reference: 1049818/10022023/R1 For Questions, contact Edge Biologicals team members: QC Manager/Microbiologist at qc@edgebiological.com / Phone 901-523-0034 or FAX 901-527-3343, or Consultant at mmedina@novaremedical.com / Phone 858-880-6635

• FDA enforcement recordOfficial FDA database entry for Z-1658-2025
• FDA device classification · QMCOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.2390The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Edge Biologicals IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.