Device recall
Z-0188-2026: Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast…
FDA device recall · Class I · BALT USA, LLC
Key facts
| Recall number (Z-number) | Z-0188-2026 |
|---|---|
| Recall event | 97661 |
| Product | Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The Mega Ballast 091 is designed with a semi-rigid proximal shaft and a highly flexible distal shaft. The… |
| Product code | DQY |
| Recalling firm | BALT USA, LLC |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K242376 |
| FEI number | 3014162263 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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