Relief ACP Oral Care Gel intended to relieve discomfort from dentin… — Class II medical device recall Z-0425-2015
Terminated recall by Discus Dental LLC, reported 2014-12-03, distributed nationwide. Product sold after April 1, 2014 were inadvertently filled with hydrogen peroxide teeth whitening gel (6% conc
| Recall number | Z-0425-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Discus Dental LLC, Ontario, CA, United States |
| Recall initiated | 2014-10-24 |
| Classified | 2014-11-24 |
| Reported by FDA | 2014-12-03 |
| Terminated | 2015-04-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, CA, CH, DE, DO, EG, FI, IN, IT, JO, KR, KW, LB, NZ, TH, TN, TR, ZA |
| Lot numbers | 14090044, 14097026, 14104024, 14104025, 14105025, 14106004, 14111008, 14113006, 14113028, 14113035, 14118015, 14121018, 14122005, 14127007, 14127009, 14127019, 14132015, 14132016, 14134020, 14134030, 14135007, 14135016, 14139005, 14141018, 14141020, 14143009, 14143017, 14143024, 14147003, 14153007, 14164002, 14169008, 881056701531, 881057001531, DHS1001, DSH1001, PV1602, PV1609, ZM2665, ZM2666 and 4 more |
Product
Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits
Reason for recall
Product sold after April 1, 2014 were inadvertently filled with hydrogen peroxide teeth whitening gel (6% concentration as dispensed) on one side of the dual barrel syringe instead of the intended component (phosphate gel). Consequently, use of this product by patients may result in a neutral effect or increased sensitivity.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0425-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.