CLASS II ONGOING Device recall · Reported 30 Apr 2025 · FDA Enforcement Report
Sterile Water Cat T-0780 Sterile Water recalled by Edge Biologicals
Edge Biologicals is recalling Sterile Water Cat T-0780 Sterile Water - Sterile water is used in making dilutions of, distributed nationwide in the US. The recall was initiated on 2 Oct 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1658-2025
- FDA event ID
- 96497
- Recalling firm
- Edge Biologicals, Memphis, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Oct 2023
- FDA classified
- 23 Apr 2025
- Reported
- 30 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Device type
- Test Kits & Diagnostics
Timeline
| 2 Oct 2023 | Recall initiated by company | |
| 23 Apr 2025 | Classified by FDA | +569 days |
| 30 Apr 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to product outer packaging incorrectly labeled.
Product as listed by the FDA
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
Where it was distributed
U.S. Nationwide distribution in the state of PA.
Questions about this recall
Why was it recalled?
Due to product outer packaging incorrectly labeled.
Which lots are affected?
Product Number: T-0780 UDI-DI code: B645T-07803012232023012320240123100E Lot Numbers: 01223
Where was it sold?
U.S. Nationwide distribution in the state of PA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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