Z-0194-2022Class I

IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and...

Name: Z-0194-2022 IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and...
Creator: Lumenis, Inc.
Published: 2021-10-14
License: https://open.fda.gov/license/

Lumenis Ltd / initiated 2021-10-14 / Terminated / root cause: manufacturing process

FDA source

Lumenis, Inc. began a recall of IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L... on 2021-10-14. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0194-2022
Classification: Class I
Status: Terminated
Initiated: 2021-10-14
Posted: 2021-11-04
Terminated: 2024-08-12
Recalling firm: Lumenis Ltd
Product: IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 10/14/21, Recall Notification Letters and Q&A fact sheets were mailed to customers. Customers were asked to immediately stop using and discard all product subject to the recall. Customers were asked to complete and return via e-mail or fax the return response form. In addition, customers who had further distributed affected product were asked to notify their customers by sharing the recall notification letter. The following phone number was provided: 1-877-Lumenis.
Quantity in commerce: 11,064
Distribution: Worldwide distribution - US Nationwide distribution in the states of KS, PR, MO, MA, NJ, NH, CA, CO, GA, NC, NY, FL, AZ, ID, IN, TX, CT, WV, UT, LA, OH, KY, SC, WA, MN, AK, IA, MD, NM, TN, RI, PA, AR, VA, IL, MI, NE, WY, ME, WI, OK, MS, SD, NV, AL, DC, OR, VT, ND, DE, HI and the countries of AT, AU, DE, GB, HK, IT, KR, CN, FR, IE, IN, LK, JP, MO, NZ, PR, TT, TW, MN, TH, CH.
Product codes and lots: Distributed within the last three years

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0194-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0194-2022	Class I	Terminated	Voluntary: Firm initiated	2021-11-10	2021-11-04

Product code ITX

K955246Class IIEcogel 200 Ultrasound GelEco-Med Pharmaceuticals, Inc. / cleared 1996-02-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)