ConMed Recalls Sterile Handpiece Sheaths Packaged in Error
ConMed is recalling sterile handpiece sheaths that were packaged in error with non-sterile units. The mislabeling could lead to the use of non-sterile sheaths.
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 (medical device) where a non-sterile item was mislabeled as sterile, creating a potential infection risk, but no injuries or illnesses have been reported in the source text.
Plain-English summary
ConMed Corporation is recalling Sterile Handpiece Sheaths, P/N 7-796-19, which are included in the Accessory Packages for the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons. The recall is limited to the accessory packages; there is no problem with the Hyfrecator 2000 Electrosurgical Unit itself.
The recall was initiated because the manufacturer packaged the accessory packages in error for over a year. Non-sterile handpiece sheaths were placed in pouches that were labeled as sterile. This mislabeling 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, Australia, Canada, Germany, Italy, the UK, Great Britain, and Ireland. Users should check their inventory for the specific serial numbers listed in the 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, 100 VOLTS AC, REF/Catalog Number 7-900-100, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Unit. -- ASSEMBLED…
- Manufacturer
- ConMed Corporation
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: 1540139
- 15280024
- 15420101
- 15470153
- 15510179
- 16010007
- 1540144
- 15280026
- 15420102
- 15470161
- 15510182
- 16010008
- 15250002
- 15290032
- 15430106
- 15490169
- 15510186
- 16010009
- 15250004
- 15290033
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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