FDA Medical Device Recalls (openFDA)
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.: FlipCutter III Drill
- Recall number
- Z-1542-2020
- Recalling firm
- T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
- Product
- FlipCutter III Drill
- Status
- Terminated
- Initiated
- 2020-01-20
- Posted
- not on file
- Terminated
- 2025-04-21
- Reason
- 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.
- Root cause
- Packaging process control
- Action
- Consignees are instructed to return the affected devices which will be replaced.
- Quantity
- 6625 units
- Distribution
- Product distributed throughout the United States, Austria, Australia, Bermuda, Switzerland, China, Germany, Denmark, France, Great Britain, Italy, Netherlands, Poland, Sweden and Taiwan.
- Lot, serial or model codes
- UDI: 10818674021446 Part Number: AR-1204FF Lots: 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, 19M12, 19M13, 19M14, 19M15, 19M16, 19M17, 19M18, 19M21, 19M22, 19N02, 19N03, 19N05, 19N06, 19N07, 19N08, 19N09, 19N11, 19N12, 19N13, 19N14, 19P01, 19P02, 19P03, 19P04, 19P05, 19P06, 19P07, 19P08, 19P09, 19P10, 19P11, 19P12, 19P13, 19R01, 19R02, 19R04, 19R05, 19R06, 19R07
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTO
- Firm FEI
- 1000272060
- Firm city
- Gatton Naharia
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28