Class II U.S. Food and Drug Administration

Boston Scientific Corporation StoneSmart Connect Console Contents recall: A subset of power adapters used with the connect console may exhibit

Recall published last month

A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during installation.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during installation.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-3188-2026
Published
September 23, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Boston Scientific Corporation
Product type
Medical devices
Units affected
982 units
Distribution
Nationwide
Made in
United States
Lot / code info
All Serial Numbers: REF: M0067933000 (UDI 00191506002510, UDI (00191506021771); REF: M006793300H0 (UDI 00191506002558); REF: M006793300R0 (UDI 00191506002534), UDI (00191506021788); REF: M006793300D0 (UDI 00191506002527); REF: M006793300Z0 (UDI 00191506002541); UPN M0067933100 (UDI 00191506022549)
UPC codes
00191506002510, 00191506021771, 00191506002558, 00191506002534, 00191506021788, 00191506002527, 00191506002541, 00191506022549

Products covered by this recall

Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1) DisplayPort Cable REF: M0067933000, M006793300H0, M006793300R0, M006793300D0, M006793300Z0, M0067930000, M006793000R0

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.

  • 00191506002510
  • 00191506021771
  • 00191506002558
  • 00191506002534
  • 00191506021788
  • 00191506002527
  • 00191506002541
  • 00191506022549

Model or item number

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

  • M0067933000
  • M006793300H0
  • M006793300R0
  • M006793300
  • M006793300D0
  • M006793300Z0

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 Device

Boston Scientific Corporation — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Boston Scientific Corporation — 100 Boston Scientific Way, Marlborough, MA, 01752-1234

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?

A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during installation. A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during installation.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00191506002510, 00191506021771, 00191506002558; model number M0067933000, M006793300H0, M006793300R0. 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?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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