Osstem Dental X-Ray System T1. Product recall: Labeling Error
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
Why was Osstem Dental X-Ray System T1. Product recalled?
Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI Codes: 08800000995793 and 08800000995526.
- Product
- Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
- Recalling firm
- OSSTEM Implant Co., Ltd.
- Quantity
- N/A
- Distribution
- U.S.
- Recall date
- November 12, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)