SINGLES Carbide US-No — Class II medical device recall Z-2937-2020
Terminated recall by Hager & Meisinger Gmbh, reported 2020-09-16, distributed nationwide. US-dates between the product package label and the bar code display.
| Recall number | Z-2937-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hager & Meisinger Gmbh, Neuss, Germany |
| Recall initiated | 2020-07-15 |
| Classified | 2020-09-04 |
| Reported by FDA | 2020-09-16 |
| Terminated | 2022-02-24 |
| Distributed | Nationwide (US) |
| Quantity | 144 units |
| Reason classes | labeling |
| Lot numbers | R50753 |
Product
SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 - Product Usage: Cutting of hard structures in the mouth, such as teeth or bone, it is also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices.
Reason for recall
US-dates between the product package label and the bar code display.
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-2937-2020. 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.