FDA Medical Device Recalls (openFDA)
Edge Biologicals Inc: Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparations
- Recall number
- Z-1658-2025
- Recalling firm
- Edge Biologicals Inc
- Product
- Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparations
- Status
- Open, Classified
- Initiated
- 2023-10-02
- Posted
- 2025-04-23
- Terminated
- not on file
- Reason
- Due to product outer packaging incorrectly labeled.
- Root cause
- Labeling mix-ups
- Action
- 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
- Quantity
- 660 units
- Distribution
- U.S. Nationwide distribution in the state of PA.
- Lot, serial or model codes
- Product Number: T-0780 UDI-DI code: B645T-07803012232023012320240123100E Lot Numbers: 01223
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QMC
- Firm FEI
- 1049818
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28