Caledonia, MI, United States
ASPEN SURGICAL recalls
1 recall recorded since 2018, most recently on 3 June 2024. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Completed Class II Medical devices
- Recall started
- 3 June 2024
- Reason
- The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2221-2024
- Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
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.