ConMed Recalls Hyfrecator 2000 Handpiece Sheaths Due to Sterility Labeling Error
ConMed is recalling Hyfrecator 2000 handpiece sheaths because non-sterile units were packaged in pouches labeled as sterile, posing a risk of infection.
What this means for you
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 (sterile 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 specific lots of Hyfrecator 2000 Handpiece Sheaths (Part Number 7-796-19). The recall is due to a packaging error where non-sterile sheaths were placed in pouches that were labeled as sterile. This error occurred over a period of more than a year.
The affected product is intended for single-patient use and is prescription-only. The recall covers specific lot numbers: 201511234, 201512074, 201512094, 201601064, and 201603284. The products were distributed nationwide in the US and internationally to Australia, Canada, Germany, Italy, the UK, Great Britain, and Ireland.
There is no problem with the Hyfrecator 2000 Electrosurgical Units themselves, nor with cases of the sheaths sold under Part Numbers 7-796-19BX or 7-796-19CS. The risk is that an end user might use a non-sterile sheath believing it to be sterile, which could lead to patient infection. Healthcare providers should check their inventory for the affected lot numbers and stop using these specific sheaths.
The recalled product
- Product
- HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single Patient Use -- CONMED CORPORATION, 525 FRENCH ROAD UTICA, NY 13502. --- There is no problem with the Hyfrecator 2000 Electrosurgical Units or with cases of P/N 7-796-19 sold in cases as P/N 7-796
- 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 (5)
- Affected Lot Numbers: 201511234
- 201512074
- 201512094
- 201601064
- 201603284
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.
See all 5 products in this recall →Related recalls
Same manufacturer · ConMed Corporation
See all →- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- HighConMed AirSeal 8mm 100mm optical obturator ports may trigger overpressure alerts
FDA (Devices) · 2026-06-24
- HighConMed AirSeal 12mm bladeless optical obturators may trigger overpressure alerts
FDA (Devices) · 2026-06-24
- HighConMed AirSeal 5mm 100mm optical obturator ports may trigger overpressure alerts
FDA (Devices) · 2026-06-24
- HighConMed AirSeal 12mm blunt tip 100mm ports may trigger overpressure alerts
FDA (Devices) · 2026-06-24
Same hazard · infection
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19