CLASS I ONGOING Device recall · Reported 10 Jul 2024 · FDA Enforcement Report
Megadyne" Mega Soft" Reusable Patient Return Electrode recalled
Megadyne Medical Products is recalling Megadyne" Mega Soft" Reusable Patient Return Electrode, distributed nationwide in the US. The recall was initiated on 17 Jun 2024 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-2249-2024
- FDA event ID
- 94837
- Recalling firm
- Megadyne Medical Products, Blue Ash, OH
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 17 Jun 2024
- FDA classified
- 3 Jul 2024
- Reported
- 10 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 17 Jun 2024 | Recall initiated by company | |
| 3 Jul 2024 | Classified by FDA | +16 days |
| 10 Jul 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catalog Number: 0830 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Single Cord, Adult, For Patients Weighing over 25lbs (11.4Kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No
Where it was distributed
Domestic: Nationwide distribution International: AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHINA, GERMANY, GREECE, INDIA, ITALY, NETHERLANDS, NORWAY, JAPAN, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, THAILAND, TURKEY, UNITED KINGDOM, UNITED STATES,
Questions about this recall
Is Megadyne" Mega Soft" Reusable Patient Return Electrode recalled?
Yes. Megadyne Medical Products recalled Megadyne" Mega Soft" Reusable Patient Return Electrode on 17 Jun 2024. The recall is Class I and its status is Ongoing. Recall number Z-2249-2024.
Why was it recalled?
To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
Which lots are affected?
Product Code: 0830; UDI-DI: 10614559101797; Lot Number: All distributed lot numbers. Product code has been discontinued from future production.
Where was it sold?
Domestic: Nationwide distribution International: AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHINA, GERMANY, GREECE, INDIA, ITALY, NETHERLANDS, NORWAY, JAPAN, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, THAILAND, TURKEY, UNITED KINGDOM, UNITED STATES,
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 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 |
| Device | CLASS I | Product Code 0846, Megadyne Mega Soft Universal Dual Patient Return recalled | Megadyne Medical Products | Lead & Heavy Metals | Nationwide |
Other Medical Software recalls
All 903| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips Brilliance recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips IQon Spectral CT Product Codes recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Ingenuity CT Product Codes recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Brilliance CT 64: Brilliance CT 64 Channel Product recalled | Philips North America | Device Malfunction | MA |
| Device | ANNOUNCED | BMC Luna G3 APAP recalled by BMC MedicalBMC | BMC Medical | Device Malfunction | Nationwide |