Lumenis, Inc. recalls 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…
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:…
Read the official notice →- Date
- 2021-11-10
- Country
- United States
- Brand
- Lumenis
- 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…
- Classification
- Class I
- Units
- Worldwide distribution - US Nationwide distribution in the states of KS, PR,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Lumenis recalls
- 2025-08-27
USLUMENIS, LTD. recalls OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and…
The potential for unsterilized product within finished product labeled as sterile.
- 2025-03-12
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LUMENIS, LTD. recalls (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3)…
The initial current in certain chargers may lead to overheating and damage to the power resistors on the Alternating Current (AC) controller during the power-on sequence of the laser system, resulting in the laser…
FDA · DeviceLUMENIS, LTD.Distribution was made to PA. There was no government/military distribution.…Official notice →
Other drugs & medical recalls in the United States
- 2021-11-10
- US
Bayer Medical Care, Inc. recalls The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an…
Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)
FDA · DeviceBayer Medical Care, Inc.Worldwide distribution - US Nationwide and the countries of AU, BY, DE, DK,…Official notice → - US
Implant Direct Sybron Manufacturing LLC recalls ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
Packaged dental implant contains a different size then the size declared on the labeling.
FDA · DeviceImplant Direct Sybron Manufacturing LLCWorldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice → - US
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
FDA · DeviceSiemens Healthcare Diagnostics, IncUS Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC,…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1…
The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results could impact clinical…
- US
FujiFilm Healthcare Americas Corporation recalls Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective Regurgitant Orifice Area (EROA) when you perform MR Flow…
- US
FujiFilm Healthcare Americas Corporation recalls Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement…