MEGADYNE Suction Coagulators recalled for fluid ingress causing device malfunction
Megadyne Medical Products is recalling 241,457 MEGADYNE Suction Coagulators due to fluid ingress into the handpiece, which may cause unintended activation, failure to activate, or self-activation during surgical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a surgical device with potential for patient harm during procedures (unintended activation or non-activation) where no illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury score at High (3).
Plain-English summary
Megadyne Medical Products, Inc. is recalling 241,457 units of MEGADYNE Suction Coagulators, surgical devices used in electrosurgery procedures. The recall involves four product codes: 004125 (10 Fr, 6 inch), 004225 (8 Fr, 6 inch), 004325 (12 Fr, 6 inch), and 0041BN (10 Fr, 6 inch, bulk non-sterile). These devices were distributed throughout the United States and internationally to 27 countries including Australia, Belgium, Canada, Chile, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, New Zealand, Norway, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, the United Arab Emirates, the United Kingdom, and Vietnam.
The FDA classified this recall as Class II due to fluid ingress into the device handpiece. Fluid entering the Suction Coagulator can cause intermittent device activation, complete non-activation, or unexpected self-activation when the device is connected to an electrosurgery unit (ESU). These malfunctions could compromise surgical safety by preventing proper device operation or causing unintended activation during procedures.
Healthcare facilities and users should immediately discontinue use of the recalled Suction Coagulators. Megadyne Medical Products, Inc. has identified specific batch numbers for each product code. Users should verify their devices against the batch numbers provided in the FDA recall notice to determine if their units are affected. The manufacturer is providing replacement devices to affected customers.
The recalled product
- Product
- MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and…
- Manufacturer
- Megadyne Medical Products, Inc.
- Affected units
- 241,457
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Product Code 004125: UDI-DI: 10614559105146
- Product Code 004225: UDI-DI: 10614559105153
- Product Code 004325: UDI-DI: 10614559105160
- Product Code 0041BN: UDI-DI: 10614559103456
Distribution
Distributed nationwide across the United States.
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