Maastricht-Airport, Netherlands
Technomed Europe recalls
3 recalls recorded since 2018, most recently on 25 July 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 25 July 2024
- Reason
- Product has have presence of brown discoloration or substance on the hinge area of the device
- Distribution
- US: FL, CA, TX, IL, NY, PA, MA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3131-2024
- NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
Terminated Class II Medical devices
- Recall started
- 9 August 2022
- Terminated
- 11 April 2024
- Reason
- Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU.
- Distribution
- US Nationwide distribution in the states of CA, FL, NH, OH, and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1737-2022
- Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Terminated Class II Medical devices
- Recall started
- 8 December 2021
- Terminated
- 31 May 2024
- Reason
- There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.
- Distribution
- US Nationwide distribution in the states of California, Florida, and Ohio.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0465-2022
- Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.