PlainRecalls

Balt USA, LLC

Compiled from official public sources by the publisher.

8 recalls on record · Latest: Nov 5, 2025

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Agency notice ledger

Federal filing book Balt USA, LLC LIGHT-BOOK · SINGLE-AGENCY

#1,701 of 14,151 · 8 notices · 0.008% archive

  • BOOK 8 notices
  • RANK #1,701 of 14,151
  • SHARE 0.008% archive
  • AGENCY FDA Devices (8)
  • CAT medical devices
  • CATS 1 category
  • LATEST Nov 5, 2025
  • PHOTO Ab Sciex

Nearest notice-volume peer: Ab Sciex (0 notice gap)

Balt USA, LLC accounts for about 0.008% of the 104,423-notice archive on 8 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where Balt USA, LLC sits among 14,151 recalling firms

Balt USA, LLC ranks 1,701st of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Balt USA, LLC vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

8 1701st of 14151 higher than 12,296 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-14

Balt USA, LLC in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Balt USA, LLC holds about 0.008% of archive notices alongside 8 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Critical Nov 5, 2025

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 hydrophil
FDA Devices Moderate Jun 25, 2025

Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810068567304 PRES2512CXPPLT 00810068567397 PRES0258CXPPLT 00810068567380 PRES0212CXPPLT 00810068567373 PRES0204CXPPLT 00810068567342 PRES0206CXPPLT 00810068567359 PRES0208CXPPLT 00810068567366 PRES3520CXPPLT 00810068567441 PRES3530CXPPLT 00810068567458 PRES0310CXPPLT 00810068567403 PRES0320CXPPLT 0081006856
FDA Devices Moderate Jun 25, 2025

Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 00810068568905 OPTI0310BLK 00810068568943 OPTI0320BLK 00810068568950 OPTI0151HSS10 00818053026614 OPTI0152HSS10 00840303701002 OPTI0153HSS10 00840303701019 OPTI0154CSS10 00818053025761 OPTI0154HSS10 00840303701026 OPTI1027CST10 00840303700142 OPTI1030HST10 00818053027086 OPTI1034COM18 0081805302646
FDA Devices Moderate Feb 14, 2024

Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms
FDA Devices Moderate Feb 14, 2024

The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral vascular abnormalities. The devices are to be placed to create blood stasis, reducing flow into the anomaly, and thrombosing the target site. The Prestige Coil System is comprised of the implant coil and a pusher assembly. There are a total of 81 Prestige coil models. Vascular Embolization Device Pre
FDA Devices Moderate Oct 26, 2022

Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
FDA Devices Moderate Sep 14, 2022

Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
FDA Devices Moderate Mar 2, 2022

The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. it is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single-patient-use device

Balt USA, LLC holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (8 here).

Ab Sciex 8 Acumedia Manufacturers, Inc. 8 Adept Medical Ltd 8 Aju Pharm Co., Ltd. 8 Ambriola Co., Inc., The 8

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Ab Sciex 8 Acumedia Manufacturers, Inc. 8 Adept Medical Ltd 8 Aju Pharm Co., Ltd. 8

Frequently Asked Questions

How many federal recall notices name Balt USA, LLC? ▼
PlainRecalls indexes 8 distinct federal recall events naming Balt USA, LLC, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Balt USA, LLC sit among other recalling firms? ▼
Balt USA, LLC ranks #1,701 of 14,151 by distinct recall-event count among 14,151 firms in this archive (87th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Balt USA, LLC's notices? ▼
FDA Devices accounts for 8 of this firm's 8 indexed notices.
What product category dominates Balt USA, LLC's filing book? ▼
Filings for Balt USA, LLC span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Balt USA, LLC: 8 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Balt USA, LLC; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026