Terragene recalls specific dental devices due to mismatch between FDA-cleared use instructions and actual product instructions. Affected units include IT26-C with extender and Benco Dental Chemical Integrator models. No immediate action required but check your product details.
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
Terragene is recalling certain dental devices because the product's actual instructions differ from the FDA-approved instructions. This mismatch could lead to incorrect use, but the recall does not require immediate action.
The product's actual instructions (IFU) do not match the FDA-cleared indications for use. This discrepancy could result in incorrect application of the device, potentially causing improper dental procedures or unintended consequences.
Dental professionals and patients using Terragene Integron IT26-C devices with specific model numbers and lot codes listed in the recall. Those most at risk are users who follow the product instructions without verifying the FDA-cleared indications.
Check for the product model numbers IT26-C, PCD26-C, or Benco Dental Chemical Integrator 5726-583 with specific lot numbers listed in the recall. The UDI-DI codes and product identifiers are also provided in the recall details.
Review the product model number, lot number, and UDI-DI code to confirm if your device is affected by this recall.
The recall is due to a discrepancy between the FDA-cleared indications for use and the actual instructions distributed with the product.
No immediate action is required. The recall does not mandate stopping use but requires checking if your device matches the listed model numbers and lot codes.
Check your device's model number and lot code against the list provided in the recall to confirm if it is affected. No specific action is required beyond verification.
We’ve drafted a message you can send Terragene to request your refund or repair — edit it as you like.
Subject: Recall Z-0836-2024 — Terragene Terragene Hello, I own a Terragene that is covered by recall Z-0836-2024 from Terragene. 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.
