Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported January 3, 2024
Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus
Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requ…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Megadyne Medical Products, Inc. recalled Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable P… - a critical-severity action.
Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable P… was recalled by Megadyne Medical Products, Inc. in January 3, 2024. Reason: Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received report…. Check the official notice for the remedy. Verify recall #Z-0599-2024 with the FDA Devices before acting.
The recall
Megadyne Medical Products, Inc. issued this critical-severity FDA Devices recall-Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received report….
- Critical
- severity level
- 2K units
- affected scope
- Class I
- classification
- January 3, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0599-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0599-2024) was formally reported on January 3, 2024, with the manufacturer initiating the action on December 8, 2023. It is classified under Critical severity (Class I), with a current status of Ongoing. Megadyne Medical Products, Inc. is listed as the recalling firm, operating out of Blue Ash, OH. Federal records list the affected scope as 2,312.
The documented reason for this recall is: Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to pro… Distribution data in the federal record shows the product reached: Worldwide distribution. US Nationwide including Puerto Rico; Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Egypt, Eswatini, Finland, France, Germany, Greece,…. 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, 3 from FDA Devices - 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2,312
Related Recalls
6
3 from same agency
Product description
Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus
Reason for recall
Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0599-2024 |
| Date reported | January 3, 2024 |
| Date initiated | December 8, 2023 |
| Recalling firm | Megadyne Medical Products, Inc. |
| Firm location | Blue Ash, OH |
| Affected scope | 2,312 |
| Distribution | Worldwide distribution. US Nationwide including Puerto Rico; Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Egypt, Eswatini, Finland, France, Germany, Greece, Hong Kong, Hungary,… |
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-0599-2024) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus. Recalled by Megadyne Medical Products, Inc.. Units affected: 2,312.
Why was this product recalled? ▼
Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 3, 2024. Severity: Critical. Recall number: Z-0599-2024.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution. US Nationwide including Puerto Rico; Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Egypt, Eswatini, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Lebanon, Malaysia, Martinique, Morocco, Netherlands, New Caledonia, Norway, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian , Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0599-2024) 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.
Nearby Recalls in This Category
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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 January 3, 2024. 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.