FDA Medical Device Recalls (openFDA)
Hager & Meisinger Gmbh: Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/10mm: 009,Head Length/mm:
- Recall number
- Z-0493-2020
- Recalling firm
- Hager & Meisinger Gmbh
- Product
- Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/10mm: 009,Head Length/mm:
- Status
- Open, Classified
- Initiated
- 2018-11-07
- Posted
- not on file
- Terminated
- not on file
- Reason
- Incorrect packaging; There is a potential that a 1.0 mm carbide blade was packaged in a 0.9 mm carbide blade packaging.
- Root cause
- Employee error
- Action
- On 10/29/2018, a medical device removal notice was mailed to the customers instructing them to do the following: 1. check your inventory for burs from the affected batch . Please return any affected instruments. You will receive a swift replacement. 2. If you have further distributed this product, please identify your customers in the response form attached . 3. Please complete the reposne orm and sent it bat to the firm at +1 (303268-5407 or by e-mail at dsanmiguel@meisingerusa.com 4. For further questions, our customer service is available at +1 (303)268-5407
- Quantity
- 2500 burs
- Distribution
- US: NV, PA, FL, SC, IA, NC-
- Lot, serial or model codes
- Lot #R23891 UDI: +E0HM26UN2453140099/$$8250523R23891+
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EJL
- Firm FEI
- 8010516
- Firm city
- Dusseldorf
- 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