Device recall
Z-2343-2025: Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF…
FDA device recall · Class I · Tandem Diabetes Care, Inc.
Key facts
| Recall number (Z-number) | Z-2343-2025 |
|---|---|
| Recall event | 97003 |
| Product | Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF: 1005611; Pump, t:slim… |
| Product code | QFG |
| Recalling firm | Tandem Diabetes Care, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K193483, K201214 |
| FEI number | 3007981285 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database