ET Rigid and Multi Dental Abutments Recalled for Incorrect Identification Stickers
Hiossen recalled ET Rigid and Multi dental abutments for incorrect identification stickers in packaging that misidentify product versions, risking improper placement during installation.
What this means for you
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: This FDA Class II recall is for a patient chart sticker labeling error that misidentifies product versions in packaging. The hazard is a documentation and identification mismatch rather than an inherent product defect, classified as a minor labeling error.
Plain-English summary
Hiossen Inc. has recalled ET Rigid and Multi dental abutments due to labeling errors in product packaging. Specifically, patient chart stickers incorrectly identify ET Rigid Abutments as "Regular" version when they are "Mini," and ET Multi Abutments as "Mini" when they are "Regular."
These abutments are dental implant components designed to provide support for prosthetic restorations including crowns, bridges, and overdentures. If a dental professional relies on the incorrect sticker identification, they could select and place the wrong-sized abutment, potentially resulting in improper fit and compromised restoration stability.
The recall affects 19 units with nationwide distribution in the United States. The affected product carries Lot Code UDI-DI: 00814913026312 and Lot #H4E21G062.
Dental professionals who have received these products should verify the actual product size directly from the product packaging or manufacturer information rather than relying solely on the patient chart stickers. Contact Hiossen Inc. for clarification if needed.
The recalled product
- Product
- ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4524MP
- Manufacturer
- Hiossen Inc.
- Hazard
- mislabeling
- improper-fit
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)
- Lot Code: UDI-DI: 00814913026312 Lot# H4E21G062
Distribution
Distributed nationwide across the United States.
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