Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 7, 2019
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.
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Alto Development Corp recalled A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (… - a moderate-severity action.
A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (… was recalled by Alto Development Corp in August 7, 2019. Reason: Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be…. Check the official notice for the remedy. Verify recall #Z-2098-2019 with the FDA Devices before acting.
The recall
Alto Development Corp issued this moderate-severity FDA Devices recall-Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be….
- Moderate
- severity level
- Class II
- classification
- August 7, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2098-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2098-2019) was formally reported on August 7, 2019, with the manufacturer initiating the action on June 21, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Alto Development Corp is listed as the recalling firm, operating out of Wall Township, NJ. Federal records list the affected scope as 351.5 Boxes.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Distribution US Nationwide, Czech Republic, Italy, Israel, and UK.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Where this recall sits in the database
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
351.5 Boxes
Related Recalls
6
0 from same agency
Product description
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 for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2098-2019 |
| Date reported | August 7, 2019 |
| Date initiated | June 21, 2019 |
| Recalling firm | Alto Development Corp |
| Firm location | Wall Township, NJ |
| Affected scope | 351.5 Boxes |
| Distribution | Distribution US Nationwide, Czech Republic, Italy, Israel, and UK. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2098-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Alto Development Corp. Units affected: 351.5 Boxes.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 7, 2019. Severity: Moderate. Recall number: Z-2098-2019.
Where was the recalled product distributed? ▼
Distribution: Distribution US Nationwide, Czech Republic, Italy, Israel, and UK..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2098-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 7, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.