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EcoGel 200 40JS-HV

by Eco-Med Pharmaceutical Inc

EcoGel 200 40JS-HV is a Class II device made by Eco-Med Pharmaceutical Inc, cleared under FDA 510(k) K955246 on 21 Feb 1996 and listed in FDA GUDID since 15 Jan 2020 (UDI-DI 00628055650997), active as of 23 Oct 2026. 13 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

10 ongoing

This device is named in the recall

Documents

510(k) K955246

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00628055650997 UDI-DI Date15 Jan 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK955246 Date21 Feb 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K955246 decided 21 Feb 1996 Active
  • FDA GUDID UDI-DI 00628055650997 listed 15 Jan 2020 Listed

Recalls

13 recalls · 10 ongoing · FDA

  • 5 recalls, same reason

    • Terminated Z-0194-2022 FDA Class I initiated 14 Oct 2021
    • Ongoing Z-0009-2022 FDA Class I initiated 7 Sep 2021
    • Ongoing Z-0029-2022 FDA Class I initiated 23 Aug 2021
    • Terminated Z-2392-2021 FDA Class I initiated 20 Aug 2021
    • Terminated Z-2391-2021 FDA Class I initiated 20 Aug 2021

    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.

  • 2 recalls, same reason

    • Ongoing Z-2582-2021 FDA Class I initiated 27 Aug 2021
    • Ongoing Z-2518-2021 FDA Class I initiated 25 Aug 2021

    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health

  • 4 recalls, same reason

    • Ongoing Z-0067-2022 FDA Class I initiated 24 Aug 2021
    • Ongoing Z-0224-2022 FDA Class I initiated 18 Aug 2021
    • Ongoing Z-2480-2021 FDA Class I initiated 12 Aug 2021
    • Ongoing Z-2469-2021 FDA Class I initiated 4 Aug 2021

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

  • 2 recalls, same reason

    • Ongoing Z-0089-2022 FDA Class I initiated 11 Aug 2021
    • Ongoing Z-0088-2022 FDA Class I initiated 11 Aug 2021

    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.

Timeline

15 dated events

  1. Recall initiated FDA recalls Z-2480-2021
  2. Recall initiated FDA recalls Z-0224-2022
  3. Recall initiated FDA recalls Z-2392-2021
  4. Recall initiated FDA recalls Z-2391-2021
  5. Recall initiated FDA recalls Z-0029-2022
  6. Recall initiated FDA recalls Z-0067-2022
  7. Recall initiated FDA recalls Z-2518-2021
  8. Recall initiated FDA recalls Z-2582-2021
  9. Recall initiated FDA recalls Z-0009-2022
  10. Recall initiated FDA recalls Z-0194-2022

5 earlier events are in the sections above.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EcoGel 200
Generic name
Skin topical coupling gel
Model / reference
40JS-HV
Primary DI / UDI-DI
00628055650997
510(k) Number
FDA product code
ITX
GMDN term
Skin topical coupling gel
Device class
Class II
Regulation number
892.1570
GUDID distribution status
In Commercial Distribution

Related devices

Category: Skin topical coupling gel

Cleared under the same submission (K955246)

and 8 more cleared under K955246

Similar devices

Other devices filed under FDA product code ITX (Transducer, Ultrasonic, Diagnostic).

Other devices from Eco-Med Pharmaceutical Inc

  • EcoLotion 85CJ Open recall

    Class II

  • Ecogel 200 40JBC Open recall

    Class II

  • EcoGel 200 40JB-HV Open recall

    Class II

  • EcoLotion 85CM Open recall

    Class II

See all devices from Eco-Med Pharmaceutical Inc →

Properties

  • Lot / batch number
  • Expiration date
Other properties (13, all answered No)