CLASS I ONGOING Device recall · Reported 20 Oct 2021 · FDA Enforcement Report

ECO 50TS Gel Tens Ultrasound X cube 1 Dispenser Btl recalled

National Distribution & Contracting is recalling ECO 50TS Gel Tens Ultrasound X cube 1 Dispenser Btl, distributed nationwide in the US. The recall was initiated on 24 Aug 2021 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll lots for the following distributed product code: Product Code: ECO 50TS - ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser

Quantity recalled3 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0068-2022
FDA event ID: 88640
Recalling firm: National Distribution & Contracting, La Vergne, TN
Classification: Class I
Status: Ongoing
Recall initiated: 24 Aug 2021
FDA classified: 13 Oct 2021
Reported: 20 Oct 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

24 Aug 2021	Recall initiated by company
13 Oct 2021	Classified by FDA	+50 days
20 Oct 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.

Product as listed by the FDA

ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl

Where it was distributed

Worldwide distribution - US Nationwide distribution including in the states of RI, AL, AR, AZ, CA, CO, CT, FL, GA, GU, HI, IA, IL, IN, KS, KY, MA, MD, LA, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA and the countries of Canada and Nova Scotia.

Nationwide Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Hawaii Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota

Questions about this recall

Why was it recalled?

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.

Which lots are affected?

All lots for the following distributed product code: Product Code: ECO 50TS - ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 88640

Reported	Class	Recall	Company	Reason	Where
20 Oct 2021	CLASS I	ECO 85CB Lotion Ultrasound 24/cs ECO 40JBC Gel Ultrasound recalled	National Distribution & Contracting	Other	Nationwide

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All 2

Reported	Class	Recall	Company	Reason	Where
20 Oct 2021Device	CLASS I	ECO 85CB Lotion Ultrasound 24/cs ECO 40JBC Gel Ultrasound recalled	National Distribution & Contracting	Other	Nationwide

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