Diversatek Healthcare ZVU Functional GI Software, REF: ZVU-3 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ZVU Functional GI Software, REF: ZVU-3
Brand
Diversatek Healthcare
Lot Codes / Batch Numbers
UDI-DI: 00816734022825, REV: 3.3.0, Software Version: 3.3.2109.6, Shipped between 5/4/2023 and 7/6/2023
Products Sold
UDI-DI: 00816734022825, REV: 3.3.0, Software Version: 3.3.2109.6, Shipped between 5/4/2023 and 7/6/2023
Diversatek Healthcare is recalling ZVU Functional GI Software, REF: ZVU-3 due to GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
Recommended Action
Per FDA guidance
Starting on 7/25/23 recall notices were mailed and emailed to customers asking them to do the following: 1) Discard affected product. 2) Contact customer service 1-800-558-6408 for replacement. 3) Complete and return the acknowledgement and receipt form.
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