CLASS II ONGOING Device recall · Reported 12 Nov 2025 · FDA Enforcement Report
Osstem Dental X-Ray System T2 recalled by OSSTEM Implant Co
OSSTEM Implant Co is recalling Osstem Dental X-Ray System T2. The recall was initiated on 26 Aug 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0314-2026
- FDA event ID
- 97869
- Recalling firm
- OSSTEM Implant Co, Haeundae District, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Aug 2025
- FDA classified
- 5 Nov 2025
- Reported
- 12 Nov 2025
- Type
- FDA Mandated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 26 Aug 2025 | Recall initiated by company | |
| 5 Nov 2025 | Classified by FDA | +71 days |
| 12 Nov 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
Where it was distributed
U.S.
Questions about this recall
Is Osstem Dental X-Ray System T2 recalled?
Yes. OSSTEM Implant Co recalled Osstem Dental X-Ray System T2 on 26 Aug 2025. The recall is Class II and its status is Ongoing. Recall number Z-0314-2026.
Why was it 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.
Which lots are affected?
UDI Codes: 08800000995601 and 08800000995618.
Where was it sold?
U.S.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from OSSTEM Implant Co
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Osstem Dental X-Ray System T2Plus recalled by OSSTEM Implant Co | OSSTEM Implant Co | Other | N/A |
| Device | CLASS II | Osstem Dental X-Ray System T1 recalled by OSSTEM Implant Co | OSSTEM Implant Co | Other | N/A |
Other Imaging Equipment recalls
All 2,336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled | Canon Medical System, USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederland B.v | Lead & Heavy Metals |