Class I U.S. Food and Drug Administration

Balt USA, LLC Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega recall: Due to an identified manufacturing defect involving coating material lifting

Recall published 12 months ago

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

The hazard: Sterility or particulate concern

Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

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

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0188-2026
Published
November 5, 2025
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Balt USA, LLC
Product type
Medical devices
Units affected
207 catheters
Distribution
Alabama, California, Colorado, Connecticut, Florida, Illinois, Kentucky, Massachusetts, New York, Tennessee, Texas, Utah
Made in
United States
Lot / code info
Model Numbers and UDI-DI codes: Model No MEGABT09180 (00840303711780) Model No MEGABT09190 (00840303711797) Model No MEGABT091100 (00840303711803) Model No MEGABT091110 (00840303711810) Lot Numbers: F250600687, F250600686, F250600685, F250600455, F250600346, F250600345, F250600010, F250501434, F250501346, F250501091, F250500824, F250400219, F250400024, F250301020, F250300297, F250100956
UPC codes
00840303711780, 00840303711797, 00840303711803, 00840303711810

Products covered by this recall

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

Check your product

The notice names 15 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00840303711780
  • 00840303711797
  • 00840303711803
  • 00840303711810

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • F250600687
  • F250600686
  • F250600685
  • F250600455
  • F250600346
  • F250600345

Model or item number

On the rating label, the box or the instruction sheet.

  • MEGABT09180
  • MEGABT09190
  • MEGABT091100
  • MEGABT09111
  • MEGABT091110

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Balt USA, LLC — Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  3. Report any infection or reaction you think the product caused to FDA MedWatch.
  4. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: BALT USA, LLC — 29 Parker Ste 100, Irvine, CA, 92618-1667

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Balt USA, LLC medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00840303711780, 00840303711797, 00840303711803; lot code F250600687, F250600686, F250600685; model number MEGABT09180, MEGABT09190, MEGABT091100. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Which states were affected?

The notice lists Alabama, California, Colorado, Connecticut, Florida, Illinois, Kentucky, Massachusetts, New York, Tennessee, Texas, Utah.

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