Theralase recalls TLC-2000 Therapeutic Medical Laser Systems with missing UDI labels for knee pain relief. No action needed as the device is safe to use but must be labeled correctly for regulatory compliance.
Device was shipped without a Unique Device Identification (UDI) label.
Theralase is recalling certain TLC-2000 Therapeutic Medical Laser Systems used for knee pain relief because they were shipped without a required UDI label. This issue does not pose a safety risk to users but is a regulatory compliance problem.
The device was shipped without a Unique Device Identification (UDI) label, which is required for regulatory compliance. This does not cause physical harm but means the product cannot be properly tracked or regulated by health authorities.
Users of the TLC-2000 laser system for knee pain relief who purchased it between the specified serial numbers. Those most at risk are individuals who have the device but may not be aware of the missing label.
Check if your TLC-2000 laser system has a serial number listed in the provided range (e.g., 3015, 3022, 3037, etc.). The device is used for temporary knee pain relief.
Look for a Unique Device Identification (UDI) label on the device; if missing, it is part of the recall.
No, the device is safe to use but was shipped without a required UDI label for regulatory compliance.
No action is needed; the device is safe to use but must be labeled correctly for regulatory compliance.
Check if your device has a serial number in the provided list; if so, it is part of the recall but no action is required beyond checking for the label.
We’ve drafted a message you can send Theralase to request your refund or repair — edit it as you like.
Subject: Recall Z-0606-2020 — Theralase Theralase Hello, I own a Theralase that is covered by recall Z-0606-2020 from Theralase. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
