FDA Medical Device Recalls (openFDA)
Hager & Meisinger Gmbh: 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.
- Recall number
- Z-2937-2020
- Recalling firm
- Hager & Meisinger Gmbh
- 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.
- Status
- Terminated
- Initiated
- 2020-07-15
- Posted
- not on file
- Terminated
- 2022-02-24
- Reason
- US-dates between the product package label and the bar code display.
- Root cause
- Process control
- Action
- The US firm sent a recall letter to the affected consignees on 07/15/2020. On 07/23/2020 an UPDATED CUSTOMER NOTIFICATION - MEDICAL DEVICE RECALL letter with customer response form was sent to the consignees by US Mail.
- Quantity
- 144 units
- Distribution
- US Nationwide distribution including in the states of AZ, CA, FL, IN, NY, PA and TX.
- Lot, serial or model codes
- LOT R50753
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EJL
- Firm FEI
- 3004169071
- Firm city
- Neuss
- Firm state
- not on file
- Firm country
- Germany
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