Megadyne Medical Products, Inc.
FDA Regulatory Profile
Megadyne Medical Products, Inc. appears in FDA public data with 20 recalls — including 16 Class I (most serious) —, 50 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2250-2024, Class I) was initiated on June 17, 2024. Its most recent 510(k) clearance was granted on July 12, 2024.
Summary
- Total Recalls
- 20 (16 Class I)
- 510(k) Clearances
- 50
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2250-2024 | Class I | Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEG | June 17, 2024 |
| Z-2248-2024 | Class I | Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patien | June 17, 2024 |
| Z-2249-2024 | Class I | Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOF | June 17, 2024 |
| Z-1920-2024 | Class I | MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patient | May 8, 2024 |
| Z-0598-2024 | Class I | Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Retu | December 8, 2023 |
| Z-0597-2024 | Class I | Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return El | December 8, 2023 |
| Z-0600-2024 | Class I | Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient | December 8, 2023 |
| Z-0599-2024 | Class I | Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Retu | December 8, 2023 |
| Z-2257-2023 | Class II | MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch | June 15, 2023 |
| Z-1994-2023 | Class I | MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery | June 1, 2023 |
| Z-2000-2023 | Class I | MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery | June 1, 2023 |
| Z-1997-2023 | Class I | MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery | June 1, 2023 |
| Z-1999-2023 | Class I | MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery | June 1, 2023 |
| Z-1998-2023 | Class I | MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery | June 1, 2023 |
| Z-1996-2023 | Class I | MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during electrosurgery | June 1, 2023 |
| Z-1995-2023 | Class I | MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery | June 1, 2023 |
| Z-2001-2023 | Class I | MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery | June 1, 2023 |
| Z-2792-2018 | Class II | MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715 | May 15, 2018 |
| Z-1151-2014 | Class II | Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number | February 27, 2014 |
| Z-2097-2013 | Class II | E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/ | August 7, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233644 | Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electro | July 12, 2024 |
| K213696 | ETHICON Megadyne Electrosurgical Generator | January 21, 2022 |
| K200250 | Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 | June 26, 2020 |
| K193145 | Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch | March 24, 2020 |
| K191328 | Megadyne Foot Switch | July 26, 2019 |
| K141587 | E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILT | February 18, 2015 |
| K133726 | MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE | January 24, 2014 |
| K080741 | MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE | December 16, 2008 |
| K081791 | E-Z CLEAN ELECTROSURGICAL ELECTRODE | October 21, 2008 |
| K072559 | SUCTION COAGULATOR | October 5, 2007 |
| K050579 | MEGA POWER ELECTROSURGICAL GENERATOR | March 24, 2005 |
| K050102 | E-Z PEN, REUSEABLE HANDSWITCHING PENCIL | February 1, 2005 |
| K040699 | LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS) | June 4, 2004 |
| K031285 | MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD | May 19, 2003 |
| K021077 | MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD | April 17, 2002 |
| K982826 | MEGA 2000 | November 6, 1998 |
| K973346 | UNCOATED ELECTROSURGICAL ELECTRODE | November 7, 1997 |
| K972273 | TBD | July 8, 1997 |
| K965054 | PENCIL | January 24, 1997 |
| K953479 | BIPOLAR FORCEPS | October 12, 1995 |