Z-0836-2024Class II

Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583]...

Name: Z-0836-2024 Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583]...
Creator: Terragene S.a.
Published: 2023-12-07
License: https://open.fda.gov/license/

Terragene LLC / initiated 2023-12-07 / Open, Classified / root cause: labeling and UDI

FDA source

TERRAGENE S.A. began a recall of Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terragene Integron... on 2023-12-07. FDA classified it as Class II and gives the reason as "Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0836-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-07
Posted: 2024-01-26
Recalling firm: Terragene LLC
Product: 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)
Product code: JOJ Indicator, Physical/Chemical Sterilization Process
Reason for recall: Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: 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.
Quantity in commerce: 36,857 strips
Distribution: U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0836-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0836-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-26
Z-0837-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-26

Product code JOJ

K191021Class IITerragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene ChemdyeTerragene S.A. / cleared 2019-09-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)