Medical sterilization chemical integrators recalled due to labeling discrepancy
TERRAGENE S.A. is recalling over 36,000 chemical integrator strips used to verify sterilization in healthcare settings because the instructions distributed with the products don't match the FDA-cleared instructions for use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device used in sterilization verification, a safety-critical function in healthcare. The discrepancy between FDA-cleared and distributed instructions represents a risk-of-harm situation where users could apply the product incorrectly, though no injuries or illnesses have been reported.
Plain-English summary
TERRAGENE S.A. is recalling approximately 36,857 chemical integrator strips used to monitor and verify sterilization processes in dental and healthcare facilities. The recall affects multiple product variants distributed nationwide in Georgia, Indiana, Michigan, Montana, New York, Pennsylvania, Texas, and Virginia.
The recall was initiated due to a discrepancy between the FDA-cleared Indications for Use (IFU) and the actual instructions distributed with the products. This mismatch could affect how users apply and interpret the chemical integrators during sterilization verification.
Affected products include the Terragene Integron IT26-C, Terragene Integron IT26-C with extender, Benco Dental Chemical Integrator, Tuttnauer, and Terragene Integron and Bionova PCD models. Specific lot numbers are provided by the FDA on its recall database.
Consumers and healthcare facilities using these products should verify their lot numbers against the FDA recall notice and contact the manufacturer or their distributor for instructions on return or replacement.
The recalled product
- 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)
- Manufacturer
- TERRAGENE S.A.
- Affected units
- 36,857
Distribution
Part of a larger recall action
This product is one of 2 recalled by TERRAGENE S.A. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · TERRAGENE S.A.
See all →- ModerateMedical device recall: sterilization validator with incorrect incubation time
FDA (Devices) · 2025-03-05
- ModerateFDA Recalls Terragene Bionova PCD Device Due to Instructions Discrepancy
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