Class II U.S. Food and Drug Administration

Boston Scientific Encore 26 Inflation Device recall: The Encore 26 Inflation Device is used with balloon dilation catheters

Recall published 1+ years ago

The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.

The hazard: Foreign material — foreign objects

Fragments of foreign objects may have got into this product during manufacture, which is why whole production codes are withdrawn rather than a handful of packs.

What the notice says: The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.

Why it matters: Pieces of foreign objects may be inside the product. The risk here is physical rather than microbial: cuts to the mouth or throat, a broken tooth, or an injury further down if a fragment is swallowed.

Symptoms and when to call a doctor

If someone has swallowed a fragment and has mouth or throat pain, trouble swallowing, chest or stomach pain, vomiting, or blood in saliva or stool, they should be seen the same day. A fragment swallowed without symptoms usually passes on its own, but tell the clinician exactly what the product was: whether it shows up on imaging depends entirely on the material, so describe the product and the notice to them.

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-2533-2025
Published
September 17, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Boston Scientific Corporation
Product type
Medical devices
Units affected
39739 units
Made in
United States
Lot / code info
1. H74904526011, GTIN 8714729177029, Lot Numbers: 34915076, 35065978; 2. H74904526052, GTIN 8714729127062, Lot Numbers: 34915078, 34915220; 3. M0067101140, GTIN 8714729755814, Lot Numbers: 34892421; 4. M001151050, GTIN 8714729183624, Lot Numbers: 34966934; 5. M001151062, GTIN 8714729137542, Lot Numbers: 34873498; 6. M00566670, GTIN 8714729755241, Lot Numbers: 35045668.
UPC codes
8714729177029, 8714729127062, 8714729755814, 8714729183624, 8714729137542, 8714729755241

Products covered by this recall

Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140; 4. M001151050; 5. M001151062; 6. M00566670. (Interventional Cardiology, Peripheral Interventions)

Check your product

The notice names 14 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.

  • 8714729177029
  • 8714729127062
  • 8714729755814
  • 8714729183624
  • 8714729137542
  • 8714729755241

Lot or batch code

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

  • 34915076
  • 35065978
  • 34915078
  • 34915220
  • 34892421
  • 34966934
  • 34873498
  • 35045668. — 39739 units

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 Foreign material

Boston Scientific Corporation — Fragments of foreign objects may have got into this product during manufacture, which is why whole production codes are withdrawn rather than a handful of packs.

  1. Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.
  2. Return it to the store or bin it sealed, and claim the refund using the lot code from the label.
  3. Check the freezer and the pantry for other packs carrying the same codes before you consider the matter closed.
  4. If someone has already bitten into something hard, have them stop, spit out what is in their mouth and rinse rather than swallow.

How to get your money back

Food recalls carry a full refund, and in the United States you usually do not need the receipt or the packaging.

  • Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.
  • Bought it online? Open the order in your account and use the refund option; marketplace sellers are required to honour a federal recall.
  • If the store refuses, contact the recalling company using the details on this page. The firm, not the shop, carries the cost of a recall.
  • If you have a loyalty card, the retailer can look the purchase up in your history — Kroger, Costco and Walmart all do this routinely.

Company contact: Boston Scientific Corporation — 1 Scimed Pl, Maple Grove, MN, 55311-1565

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 Boston Scientific Corporation medical devices recalled?

The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter. The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 8714729177029, 8714729127062, 8714729755814; lot code 34915076, 35065978, 34915078. 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 eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.

Can I get my money back?

Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.

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