Terragene Integron IT26-C recallZ-0836-2024 · Terragene S.A. · initiated Dec 7, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Terragene S.A. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
FDA root cause category: Labeling False and Misleading
What the company is doing
On 12/07/2023, the firm notified via email its initial importers/distributor a "Voluntary Recall Notification " that contained a "COMMUNICATION TO CUSTOMER VOLUNTARY RECALL OF PRODUCT/URGENT: MEDICAL DEVICE RECALL" Letter informing them of the discrepancies identified in the IFUs of some products that mentions extended cycles that may mislead users to think that these cycles are part of the FDA-cleared indications for use of the product. Initial Importers/Distributors are instructed to send the following information to Terragene: -Quantity in stock -Quantity distributed -Consignees On or about 12/22/2023, the firm initiated distribution, via email, an "URGENT: MEDICAL DEVICE RECALL" Letter to customers (identified by their Initial Imports/Distributors) informing them of the Recall issue (discrepancy identified in the IFU) provide an updated IFU (version 4) correcting the issue. Customers are instructed to print the updated IFU and attach it to their remaining inventory, and to discard the older IFU versions (version 1 thru 3). For questions or concerns, contact [email protected] or www.terragene.com , or +1-844-837-7243 Monday thru Friday 6:00 AM to 3:00 PM, Eastern Time.
Recall details
- Recall number
- Z-0836-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 7, 2023
- Posted by the FDA
- Jan 26, 2024
- Recalling firm
- Terragene S.A.
- Quantity
- 36,857 strips
- Product code
- JOJ
- FDA submissions
- K191021
- Distribution
- U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.
Product description
Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terragene Integron (PCD26-C) Terragene Bionova PCD (PCD222-C)
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
Product Number: IT26-C UDI-DI code: 07798164679622 Lot Numbers: 19033 19038 19039 19040 19057 19105-12 19105-16 B10400-13 B10400-14 B10400-16 B10400-21 B10400-23 19105-23 19105-24 B10519 B10555 B10625 B10627 B10628 B10629 B20040 B20043 B30012 B30013 B30110 B30111 B30112 Product Number: IT26-C with extender UDI-DI code: 07798164678656 Lot Numbers: 19059 B10572 B30068 B30110 Product Number: Terragene Integron (PCD26-C) UDI-DI code: 07798164679370 Lot Numbers: 100320 110320 220620 F10009 F20026 F20079 F20084 Product Number: Benco Dental Chemical Integrator 5726-583 UDI-DI code: 00366975058768 Lot Numbers: 131120-8 131120-1 131120-2 131120-4 131120-7 131120-5 131120-11 131120-3 131120-16 131120-15 131120-12 131120-19 131120-10 131120-6 131120-18 131120-17 131120-14 131120-13 131120-9 B10540 B20039 B20185 B20576 B30010 B30138 Product Number: Tuttnauer (WTL198-0082) UDI-DI code: 07798164677888 Lot Numbers: 120320 170920-3 170920-2 170920-1 170920-8 170920-7 170920-6 170920-5 170920-4 B10331-1 B10331-2 B10331-3 B10539 B20679
Devices named in this recall
5 devices in the FDA device registry whose identifier appears in the recall's code information.
- Integron® IT26-CTerragene S.A. · Indicator, Physical/Chemical Sterilization Process1 recall5 reports
- BENCO 5726-583Benco Dental Supply CO. · Indicator, Physical/Chemical Sterilization Process1 recall0 reports
- Tuttnauer® WTL198-0082Terragene S.A. · Indicator, Physical/Chemical Sterilization Process1 recall0 reports
- Integron® IT26-CTerragene S.A. · Indicator, Physical/Chemical Sterilization Process1 recall0 reports
- Integron® PCD26-CTerragene S.A. · Indicator, Physical/Chemical Sterilization Process1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 93625).
- Z-0837-2024 · Open, ClassifiedTerragene Bionova PCD (PCD222-C)
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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