Exact FDA event identifier

Event 92409

8 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: June 01, 2023
Product types: Device
Classifications: Class I
Statuses: Ongoing
Recalling firm wording: Megadyne Medical Products, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

8 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 8

MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery

Z-1994-2023

Recall number: Z-1994-2023
Initiated: June 01, 2023
Classification: Class I
Status: Ongoing
Recalling firm: Megadyne Medical Products, Inc.
Quantity: 21,100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Firm has received reports of patient burns in surgical procedures where device was used.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm has received reports of patient burns in surgical procedures where device was used.

Code information

Model No. 0800; UDI-DI: 10614559100936; All Units.

Distribution pattern

Distributed US Nationwide.

device · product 2 of 8

MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery

Z-1995-2023

Recall number: Z-1995-2023
Initiated: June 01, 2023
Classification: Class I
Status: Ongoing
Recalling firm: Megadyne Medical Products, Inc.
Quantity: 21,100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Firm has received reports of patient burns in surgical procedures where device was used.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm has received reports of patient burns in surgical procedures where device was used.

Code information

Model No. 0830; UDI-DI: 10614559101797; All Units.

Distribution pattern

Distributed US Nationwide.

device · product 3 of 8

MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during electrosurgery

Z-1996-2023

Recall number: Z-1996-2023
Initiated: June 01, 2023
Classification: Class I
Status: Ongoing
Recalling firm: Megadyne Medical Products, Inc.
Quantity: 21,100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Firm has received reports of patient burns in surgical procedures where device was used.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm has received reports of patient burns in surgical procedures where device was used.

Code information

Model No. 0835; UDI-DI: 10614559101872; All Units.

Distribution pattern

Distributed US Nationwide.

device · product 4 of 8

MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery

Z-1997-2023

Recall number: Z-1997-2023
Initiated: June 01, 2023
Classification: Class I
Status: Ongoing
Recalling firm: Megadyne Medical Products, Inc.
Quantity: 21,100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Firm has received reports of patient burns in surgical procedures where device was used.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm has received reports of patient burns in surgical procedures where device was used.

Code information

Model No. 0840; UDI-DI: 10614559103395; All Units.

Distribution pattern

Distributed US Nationwide.

device · product 5 of 8

MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery

Z-1998-2023

Recall number: Z-1998-2023
Initiated: June 01, 2023
Classification: Class I
Status: Ongoing
Recalling firm: Megadyne Medical Products, Inc.
Quantity: 21,100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Firm has received reports of patient burns in surgical procedures where device was used.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm has received reports of patient burns in surgical procedures where device was used.

Code information

Model No. 0845; UDI-DI: 10614559103906; All Units.

Distribution pattern

Distributed US Nationwide.

device · product 6 of 8

MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery

Z-1999-2023

Recall number: Z-1999-2023
Initiated: June 01, 2023
Classification: Class I
Status: Ongoing
Recalling firm: Megadyne Medical Products, Inc.
Quantity: 21,100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Firm has received reports of patient burns in surgical procedures where device was used.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm has received reports of patient burns in surgical procedures where device was used.

Code information

Model No. 0847; UDI-DI: 10614559104842; All Units.

Distribution pattern

Distributed US Nationwide.

device · product 7 of 8

MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery

Z-2000-2023

Recall number: Z-2000-2023
Initiated: June 01, 2023
Classification: Class I
Status: Ongoing
Recalling firm: Megadyne Medical Products, Inc.
Quantity: 21,100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Firm has received reports of patient burns in surgical procedures where device was used.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm has received reports of patient burns in surgical procedures where device was used.

Code information

Model No. 0848; UDI-DI: 10614559104859; All Units.

Distribution pattern

Distributed US Nationwide.

device · product 8 of 8

MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery

Z-2001-2023

Recall number: Z-2001-2023
Initiated: June 01, 2023
Classification: Class I
Status: Ongoing
Recalling firm: Megadyne Medical Products, Inc.
Quantity: 21,100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Firm has received reports of patient burns in surgical procedures where device was used.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm has received reports of patient burns in surgical procedures where device was used.

Code information

Model No. 0846; UDI-DI: 10614559104248; All Units.

Distribution pattern

Distributed US Nationwide.