Z-1658-2025Class II

Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in...

Name: Z-1658-2025 Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in...
Creator: Edge Biologicals Inc
Published: 2023-10-02
License: https://open.fda.gov/license/

Edge Biologicals, Inc. / initiated 2023-10-02 / Open, Classified / root cause: labeling and UDI

FDA source

Edge Biologicals Inc began a recall of 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... on 2023-10-02. FDA classified it as Class II and gives the reason as "Due to product outer packaging incorrectly labeled". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1658-2025
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-02
Posted: 2025-04-23
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
Product code: QMC Transport Medium, Notified Per The Vtm Guidance
Reason for recall: Due to product outer packaging incorrectly labeled.
Root cause tag: labeling and UDI
FDA 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 [email protected] 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 [email protected] / Phone 901-523-0034 or FAX 901-527-3343, or Consultant at [email protected] / Phone 858-880-6635
Quantity in commerce: 660 units
Distribution: U.S. Nationwide distribution in the state of PA.
Product codes and lots: Product Number: T-0780 UDI-DI code: B645T-07803012232023012320240123100E Lot Numbers: 01223

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1658-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1658-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-23

Product code QMC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)