W&H Surgical handpiece S-12 — Class II medical device recall Z-1168-2024
Ongoing recall by W&H DENTALWERK BUERMOOS GMBH, reported 2024-02-28, distributed nationwide. 1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. The specific la
| Recall number | Z-1168-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | W&H DENTALWERK BUERMOOS GMBH, BUERMOOS, N/A, Austria |
| Recall initiated | 2024-01-16 |
| Classified | 2024-02-20 |
| Reported by FDA | 2024-02-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, PH, SE |
| Quantity | 160 units |
| Serial numbers | 04931, 04932, 04933, 04934, 04935, 04936, 04937, 04938, 04939, 04940, 04941, 04942, 04943, 04944, 04945, 04946, 04947, 04948, 04949, 04950, 04951, 04952, 04953, 04954, 04955 and 135 more |
| Model numbers | 30061000 |
Product
W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
Reason for recall
1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. The specific laser marking should read 1:2, but instead it reads 1:1 on the body of the handpiece
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-1168-2024. 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.