FDA Device recall Z-2098-2019
A&E Medical Corp
- FDA Device
- Class II
- terminated
- Published 2019-08-07
On 2019-08-07 the FDA classified a Class II recall of A&E Medical Corp by Alto Development, citing updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be consistent between electrode IFU and instructions for M-21 loop.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2098-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-21 |
| Published | 2019-08-07 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Alto Development |
| Distribution | US |
Product
A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) Used as a connection between temporary cardiac pacing or monitoring equipment and the heart.
Reason
Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be consistent between electrode IFU and instructions for M-21 loop.
Identifiers
| code_info | Lots 0715A or later |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2098-2019%22
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