CLASS I ONGOING Device recall · Reported 3 Jan 2024 · FDA Enforcement Report
Product Code 0847, Megadyne Mega Soft Universal Plus Patient Return recalled
Megadyne Medical Products is recalling Product Code 0847, Megadyne Mega Soft Universal Plus Patient Return, distributed nationwide in the US. The recall was initiated on 8 Dec 2023 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0599-2024
- FDA event ID
- 93597
- Recalling firm
- Megadyne Medical Products, Blue Ash, OH
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 8 Dec 2023
- FDA classified
- 26 Dec 2023
- Reported
- 3 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 8 Dec 2023 | Recall initiated by company | |
| 26 Dec 2023 | Classified by FDA | +18 days |
| 3 Jan 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus
Where it was distributed
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
Questions about this recall
Is Product Code 0847, Megadyne Mega Soft Universal Plus Patient Return recalled?
Yes. Megadyne Medical Products recalled Product Code 0847, Megadyne Mega Soft Universal Plus Patient Return on 8 Dec 2023. The recall is Class I and its status is Ongoing. Recall number Z-0599-2024.
Why was it 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 lots are affected?
UDI-DI 10614559104842 All units in expiry
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Megadyne Medical Products
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Megadyne" Mega Soft" Dual Reusable Patient Return Electrode recalled | Megadyne Medical Products | Device Malfunction | Nationwide |
| Device | CLASS I | Megadyne" Mega 2000" Patient Return Electrode recalled | Megadyne Medical Products | Device Malfunction | Nationwide |
| Device | CLASS I | Megadyne" Mega Soft" Reusable Patient Return Electrode recalled | Megadyne Medical Products | Device Malfunction | Nationwide |
| Device | CLASS I | Megadyne Mega Soft Pediatric Patient Return Electrode recalled | Megadyne Medical Products | Other | Nationwide |
| Device | CLASS I | Product Code 0845, Megadyne Mega Soft Universal Patient Return recalled | Megadyne Medical Products | Lead & Heavy Metals | Nationwide |
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