IPL Coupling Gel and EcoGel 200 Recalled for Bacterial Contamination
Lumenis, Inc. is recalling IPL Coupling Gel and EcoGel 200 due to potential bacterial contamination. Approximately 11,064 units were distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4 per the rubric. Bacterial contamination in medical devices represents a serious hazard, though no illnesses or injuries have been reported.
Plain-English summary
Lumenis, Inc. is recalling ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, including IPL Coupling Gel and EcoGel 200. Approximately 11,064 units have been distributed.
The products may contain bacterial contamination. On August 18, 2021, the FDA published a letter to health care providers advising the immediate discontinuation of all Eco-Med ultrasound gels and lotions due to this contamination risk.
Affected products were distributed worldwide and throughout the United States. Products distributed within the last three years may be affected.
Health care providers and consumers should stop using affected products immediately and contact Lumenis, Inc. for instructions regarding disposal and replacement information.
The recalled product
- 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
- Manufacturer
- Lumenis, Inc.
- Category
- Medical Device — Ultrasound Gel
- Hazard
- bacterial-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Distributed within the last three years
Distribution
Distributed nationwide across the United States.
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