Lutronic Corporation recalls Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of…
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
Read the official notice →- Date
- 2026-09-16
- Country
- United States
- Brand
- Lutronic
- Product
- Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Canada and…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Lutronic recalls
- 2026-03-18
USLutronic Corporation recalls CLARITY II Laser System; Model No. 1110200210.
Reports of devices sparking/popping and potentially burning patients.
FDA · DeviceLutronic CorporationWorldwide distribution - US Nationwide and the countries of Canada, South…Official notice →- 2025-10-22
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Lutronic Corporation recalls XERF EFFECTOR 60. Electrosurgical unit.
Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.
FDA · DeviceLutronic CorporationWorldwide - US Nationwide distribution in the states of CA, IL, MA, NJ, NY,…Official notice →
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Atrium Medical Corporation recalls Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4.…
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
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AVID Medical, Inc. recalls Halyard IV Start Kit Non-Sterile REF: KRIV26-02
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- US
Medical Action Industries, Inc. 306 recalls Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF: 83945B. Containing Sodium Chloride…
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FDA · DeviceMedical Action Industries, Inc. 306US distribution to states of: IA, VA, MO, KS, FL, OH and LS.Official notice → - US
Given Imaging Ltd. recalls Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used…
Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding,…
FDA · DeviceGiven Imaging Ltd.Worldwide distribution. US nationwide including Puerto Rico; Argentina,…Official notice →