3M ClarityRecalls & reported problems across all models
3m Unitek Corporation · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one 3M Clarity model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 9 models of 3M Clarity by 3m Unitek Corporation in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Jun 25, 2021 and Jun 25, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
3M Clarity recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 22, 2024Open, Classified
Attachments may not mate with the tooth as intended in the digital treatment design.
Z-0743-2025 · Root cause: Software design (manufacturing process) · names 8 of these models · Recall details · FDA record ↗
Most reported 3M Clarity problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Cellulitis1
- Laceration(s)1
3M Clarity models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 3M™ Clarity™ 359-830Aligner, sequential1 recall0 reports
- 3M™ Clarity™ 359-831Aligner, sequential1 recall0 reports
- 3M™ Clarity™ 359-832Aligner, sequential1 recall0 reports
- 3M™ Clarity™ 359-833Aligner, sequential1 recall0 reports
- 3M™ Clarity™ 359-834Aligner, sequential1 recall0 reports
- 3M™ Clarity™ 359-835Aligner, sequential1 recall0 reports
- 3M™ Clarity™ 359-836Aligner, sequential1 recall0 reports
- 3M™ Clarity™ 359-837Aligner, sequential1 recall0 reports
- 3M™ Clarity™ 359-455Aligner, Sequential1 report
Recent 3M Clarity adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 25, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
A THREE-DAY HOSPITALIZATION FOR SUBMENTAL CELLULITIS OF THE NECK WAS REPORTED THAT RESULTED DURING ORTHODONTIC TREATMENT WITH 3M CLARITY ALIGNERS. PRIOR TO THE HOSPITALIZATION, THE ALIGNERS WERE TRIMMED DUE TO ALLEGED CUTTING OF THE TONGUE AND ROOF OF THE MOUTH. TREATMENT INCLUDED ADMINISTRATION OF AN INTRAVENOUS ANTIBIOTIC (UNSPECIFIED) AND ORAL CLINDAMYCIN UPON DISCHARGE. DISCHARGE INSTRUCTED TO COMPLETE THE COURSE OF ANTIBIOTICS AS PRESCRIBED, TO APPLY WARM COMPRESSES TO THE AFFECTED AREA. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE CELLULITIS WAS CAUSED BY AN INSECT BITE. THE PATIENT IS CONTINUING ORTHODONTIC TREATMENT WITH 3M CLARITY ALIGNERS.
Patient problems: Cellulitis; Laceration(s)
MAUDE report 12067947 ↗
Other 3m Unitek Corporation products
All 3m Unitek Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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