Ormco Recalls TF Adaptive Gutta Percha Points Due to Labeling Error
Ormco is recalling TF Adaptive Gutta Percha Points because the inner label is misidentified as ML3, though the outer package correctly identifies the product as SM3.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text indicates a labeling error where the outer package correctly identifies the product, limiting the risk to potential confusion rather than direct harm.
Plain-English summary
Ormco Corporation is recalling TF Adaptive Gutta Percha Point Size SM3 50pk (Part No. 815-1541) due to a labeling discrepancy. The inner generic label on the product is identified as ML3, while the outer package correctly identifies the product as SM3, which matches the actual product inside.
The recall involves 5,568 units total, with 2,070 units distributed in the United States. The products were distributed worldwide, including in Canada, Australia, Mexico, Europe, Hong Kong, Malaysia, India, Japan, Indonesia, Singapore, and Thailand.
Healthcare professionals and consumers should stop using the affected products and contact Ormco/Sybronendo for instructions on how to return the items.
The recalled product
- Product
- TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
- Manufacturer
- Ormco/Sybronendo
- Category
- Medical Device — Dental
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GE15011637
Distribution
Distributed nationwide across the United States.
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