ConMed Recalls Hyfrecator 2000 Accessory Packages with Non-Sterile Sheaths
ConMed is recalling Hyfrecator 2000 accessory packages because they contained non-sterile handpiece sheaths labeled as sterile.
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 labeled as sterile) where injury has not yet been reported, fitting the High severity criteria.
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 affects the 220 VOLTS AC units with REF/Catalog Number 7-900-220. The Hyfrecator 2000 Electrosurgical Units themselves are not affected by this recall.
The recall was initiated because the accessory packages were packaged in error by the manufacturer. Non-sterile handpiece sheaths were placed in pouches that were labeled as sterile. This packaging error could cause an end user to use a non-sterile sheath as if it were sterile.
The affected products were distributed worldwide, including in the United States (nationwide), Australia, Canada, Germany, Italy, the UK, Great Britain, and Ireland. Users should check their inventory for the specific serial numbers listed in the official recall notice and stop using the affected sheaths.
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 , 220 VOLTS AC, REF/Catalog Number 7-900-220, Rx Only, There is no problem with the Hyfrecator 2000 Electrosurgical Units…
- Manufacturer
- ConMed Corporation
- Hazard
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 (20)
- Serial Numbers: 1540070
- 15450384
- 15500476
- 16020037
- 16150086
- 16260128
- 16360182
- 16450236
- 15320037
- 15450385
- 15500477
- 16020038
- 16150087
- 16260129
- 16360183
- 16450237
- 15330049
- 15450386
- 15500478
- 16020039
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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