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Lower risk Medical device recall · FDA · Published June 15, 2017

Boston Scientific Encore 26 Inflation Device Recall: Cracked Trays Reported

Boston Scientific recalls Encore 26 Inflation Devices with specific catalog and serial numbers due to reported cracked trays. Consumers should check their device details to determine if affected.

🇺🇸 FDA recall #Z-3043-2017Medical deviceBoston Scientific ›
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Recalling firmBoston Scientific Corporation100 Boston Scientific Way · Marlborough, MA 01752-1234
✎ GovInfoNow plain-language explainer

What happened, in plain English

Boston Scientific is recalling certain Encore 26 Inflation Devices because users have reported cracked trays. This issue could lead to device failure during medical procedures, potentially causing complications for patients. Read more at govinfonow.com/recall/73861-boston-scientific-encore-26-inflation-device-recall-cracked-trays-reported.

Source Summary by GovInfoNow · govinfonow.com/recall/73861-boston-scientific-encore-26-inflation-device-recall-cracked-trays-reported · Updated September 23, 2026 · FDA enforcement record: FDA #Z-3043-2017

Cite this page

“Boston Scientific Encore 26 Inflation Device Recall: Cracked Trays Reported.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73861-boston-scientific-encore-26-inflation-device-recall-cracked-trays-reported. Based on FDA recall #Z-3043-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3043-2017%22&limit=1).

Why it’s dangerous

Cracked trays on the Encore device can cause it to malfunction during medical procedures. This may lead to improper device function, potentially causing complications for patients during treatment.

Who’s affected

Medical professionals using the Encore 26 Inflation Device for procedures are most at risk. Patients receiving these devices during medical treatments may be affected if the device cracks.

How to tell if you have this one

Check the catalog numbers: H74904526011, M001151050, M00566670, or M0067101140. Also verify the serial numbers listed in the recall notice for your specific device.

  • Brand
    Boston Scientific
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Details

    Review the catalog and serial numbers on your Encore 26 Inflation Device to confirm if it is in the recalled list.

How this recall unfolded

Recall timeline

FDA terminated this recall 3.1 years after the firm started it.

1. Firm started the recall: Jun 15, 201712. FDA classified it Class II: Aug 16, 201723. Published in FDA’s Enforcement Report: Aug 23, 201734. FDA terminated the recall: Jul 22, 2020420172020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is this device dangerous if it cracks?

The recall reports cracked trays, which could cause device malfunction during medical procedures. However, the hazard is not described as causing serious injury in normal use.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-3043-2017 (June 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3043-2017 to see it in context.
  • Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA