Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0188-2026 — 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. T

U.S. FDA — Device Enforcement · United States · 2025-09-25 · Class I

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0188-2026
Date of alert: 2025-09-25
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: BALT USA, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00840303711780

Reported risk: Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Related