Megadyne MegaTip, E-Z Clean Non Stick Cautery Tip, CAT/REF… recallZ-0468-03 · Megadyne Medical Products, Inc · initiated Dec 20, 2002
Terminated All recalls posted in January 2003
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Megadyne Medical Products, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The metal substrate cautery tip may break during use.
FDA root cause category: Other
What the company is doing
On 12/20/2002, all consignees were notified by letter to return all affected product.
Recall details
- Recall number
- Z-0468-03
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 20, 2002
- Posted by the FDA
- Jan 30, 2003
- Recalling firm
- Megadyne Medical Products, Inc
- Quantity
- 19464
- Product code
- GEI
- FDA submissions
- K943055
- Distribution
- Nationwide. Foreign distribution to Australia, Belgium, Canada, Italy, Korea, New Zealand, Sweden.
Product description
Megadyne MegaTip, E-Z Clean Non Stick Cautery Tip, CAT/REF 0600, Single Use Only, STERILE
Code information (models, lots, serial numbers)
Catalog Number 0600. Lots 00664, 00845, 10038, 10190, 10541, 10669, 10703, 10766, 10951, 11110, 11356, 20046, 20219, 20520, 20592, 20757, 20777, 20856, 20997, 21075.
Other devices under the same FDA submission
4 devices cleared under K943055 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Megadyne 0690SMegadyne Medical Products, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Megadyne 0600Megadyne Medical Products, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Megadyne 0600MMegadyne Medical Products, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Megadyne 0695Megadyne Medical Products, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 25265).
- Z-0469-03 · TerminatedMegadyne MegaTip, Modified E-Z Clean Non Stick Cautery Tip, CAT/REF 0600M, Single Use Only, STERILE
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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