Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega… — Class I medical device recall Z-0188-2026
Ongoing recall by BALT USA, LLC, reported 2025-11-05, distributed in AL, CA, CO, CT, FL, IL, KY, MA…. Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inne
| Recall number | Z-0188-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BALT USA, LLC, Irvine, CA, United States |
| Recall initiated | 2025-09-25 |
| Classified | 2025-10-24 |
| Reported by FDA | 2025-11-05 |
| Distributed | AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, UT |
| Quantity | 207 catheters |
| UPC / GTIN / UDI-DI | 00840303711780, 00840303711797, 00840303711803, 00840303711810 |
| Lot numbers | F250100956, F250300297, F250301020, F250400024, F250400219, F250500824, F250501091, F250501346, F250501434, F250600010, F250600345, F250600346, F250600455, F250600685, F250600686, F250600687 |
| Model numbers | MEGABT091100, MEGABT091110, MEGABT09180, MEGABT09190 |
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 design facilitates the advancement of the Mega Ballast to access the tortuous vasculature over a guidewire and a respective dilator. The outer surface of the Mega Ballast is coated with a hydrophilic coating to facilitate lubricity from tip to 40 cm proximal. The proximal end of the Mega Ballast incorporates a Luer fitting hub for the attachment of accessories. The Mega Ballast is provided sterile, non-pyrogenic, and is intended for single use only. Component: Not a component
Reason for recall
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0188-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.