ConMed Recalls Hyfrecator 2000 ESU Cartons with Non-Sterile Handpiece Sheaths
ConMed is recalling Hyfrecator 2000 ESU cartons because they were packaged with non-sterile handpiece sheaths labeled as sterile, posing a risk of infection.
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: The recall involves a risk-of-harm product (non-sterile medical device used as sterile) where injury has not yet been reported, which aligns with the 'High' severity criteria for theoretical hazards in medical devices.
Plain-English summary
ConMed Corporation is recalling Sterile Handpiece Sheaths (P/N 7-796-19) included in the Accessory Packages for the Hyfrecator 2000 Electrosurgical Unit (ESU) cartons. The recall is due to a packaging error where non-sterile sheaths were placed in pouches labeled as sterile.
The affected products were distributed worldwide, including in the United States, Australia, Canada, Germany, Italy, the UK, Great Britain, and Ireland. The Hyfrecator 2000 ESU units themselves are not affected by this recall; only the specific accessory packages containing the mislabeled sheaths are involved.
End users should stop using the affected handpiece sheaths immediately. Using a non-sterile sheath as if it were sterile could lead to patient infection. Healthcare facilities should check their inventory for the specific serial numbers listed in the official recall notice and contact ConMed Corporation for further instructions on returning or replacing the products.
The recalled product
- Product
- Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 115 VOLTS AC, REF/Catalog Number 7-900-115, Rx Only . There is no problem with the Hyfrecator 2000 Electrosurgical Units.…
- Manufacturer
- ConMed Corporation
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by ConMed Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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