Hopkinton, NY, United States
Numed Inc recalls
2 recalls recorded since 2018, most recently on 21 April 2025. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 21 April 2025
- Terminated
- 17 December 2025
- Reason
- Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.
- Distribution
- US distribution to Pennsylvania.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1754-2025
- BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Terminated Class II Medical devices
- Recall started
- 17 October 2018
- Terminated
- 28 January 2019
- Reason
- Instructions for Use booklets were not included on the outer pouch
- Distribution
- US distribution in the state of PA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0510-2019, Z-0511-2019
- Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contr
- Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contr
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.