CLASS I ONGOING Device recall · Reported 5 Jul 2023 · FDA Enforcement Report
Megadyne Mega Soft Universal Patient Return Electrode recalled
Megadyne Medical Products is recalling Megadyne Mega Soft Universal Patient Return Electrode, distributed nationwide in the US. The recall was initiated on 1 Jun 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-1998-2023
- FDA event ID
- 92409
- Recalling firm
- Megadyne Medical Products, Blue Ash, OH
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 1 Jun 2023
- FDA classified
- 29 Jun 2023
- Reported
- 5 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 1 Jun 2023 | Recall initiated by company | |
| 29 Jun 2023 | Classified by FDA | +28 days |
| 5 Jul 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Firm has received reports of patient burns in surgical procedures where device was used.
Product as listed by the FDA
MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery
Where it was distributed
Distributed US Nationwide.
Questions about this recall
Is Megadyne Mega Soft Universal Patient Return Electrode recalled?
Yes. Megadyne Medical Products recalled Megadyne Mega Soft Universal Patient Return Electrode on 1 Jun 2023. The recall is Class I and its status is Ongoing. Recall number Z-1998-2023.
Why was it recalled?
Firm has received reports of patient burns in surgical procedures where device was used.
Which lots are affected?
Model No. 0845; UDI-DI: 10614559103906; All Units.
Where was it sold?
Distributed US Nationwide.
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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