FlipCutter III Drill — Class II medical device recall Z-1542-2020
Terminated recall by T.A.G. MEDICAL PRODUCTS CORPORATION, LTD., reported 2020-04-01, distributed nationwide. There is potential for the blister tray to be cracked causing the sterile barrier to be compromised and potent
| Recall number | Z-1542-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD., Naharia, N/A, Israel |
| Recall initiated | 2020-01-20 |
| Classified | 2020-03-20 |
| Reported by FDA | 2020-04-01 |
| Terminated | 2025-04-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BM, CH, CN, DE, DK, FR, GB, IT, NL, PL, SE, TW |
| Quantity | 6,625 units |
| Reason classes | sterility, specification failure, packaging |
| UPC / GTIN / UDI-DI | 10818674021446 |
| Lot numbers | 19E01, 19E02, 19E03, 19E05, 19E10, 19E11, 19F01, 19F02, 19F03, 19F04, 19F05, 19F06, 19F07, 19F08, 19F09, 19F10, 19J15, 19J16, 19J17, 19J18, 19J19, 19J20, 19J21, 19J22, 19J23, 19J24, 19J25, 19J26, 19J28, 19J29, 19K01, 19K02, 19K03, 19K09, 19K11, 19K12, 19M01, 19M09, 19M10, 19M11 and 39 more |
| Model numbers | 19E01, 19E02, 19E03, 19E05, 19E10, 19E11, 19F01, 19F02, 19F03, 19F04, 19F05, 19F06, 19F07, 19F08, 19F09, 19F10, 19J15, 19J16, 19J17, 19J18, 19J19, 19J20, 19J21, 19J22, 19J23 and 55 more |
Product
FlipCutter III Drill
Reason for recall
There is potential for the blister tray to be cracked causing the sterile barrier to be compromised and potential for particulate within the sterile barrier.
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-1542-2020. 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.