Exact FDA event identifier

Event 93625

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: December 07, 2023
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: TERRAGENE S.A.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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)

Z-0836-2024

Recall number: Z-0836-2024
Initiated: December 07, 2023
Classification: Class II
Status: Ongoing
Recalling firm: TERRAGENE S.A.
Quantity: 36,857 strips

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.

Code information

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

Distribution pattern

U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.

device · product 2 of 2

Terragene Bionova PCD (PCD222-C)

Z-0837-2024

Recall number: Z-0837-2024
Initiated: December 07, 2023
Classification: Class II
Status: Ongoing
Recalling firm: TERRAGENE S.A.
Quantity: 80 stripes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.

Code information

Product Number: Terragene Bionova PCD (PCD222-C) UDI-DI code: 07798164676027 Serial Numbers: F20002 F20021 F20046

Distribution pattern

U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.