The Recall Desk
HighFDA (Devices)·Z-1759-2017·Announced 2017-04-19

ConMed Recalls Sterile Handpiece Sheaths Packaged as Non-Sterile

ConMed is recalling sterile handpiece sheaths that were incorrectly packaged with non-sterile units. This error could lead to the use of non-sterile sheaths in medical procedures.

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 is classified as FDA Class II. The hazard involves the potential use of non-sterile medical devices, which poses a risk of harm (infection) even though 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 involves units with REF/Catalog Number 7-900-230, 230 VOLTS AC, which are prescription-only. The source text clarifies that there is no problem with the Hyfrecator 2000 Electrosurgical Units themselves, only the accessory sheaths.

The recall was initiated because, for over a year, the manufacturer packaged the Accessory Packages in error. Non-sterile P/N 7-796-19 Handpiece Sheaths were placed in pouches that were labeled as Sterile. This packaging error creates a risk that an end user might use a non-sterile sheath as if it were sterile during a procedure.

The affected products were distributed worldwide, including nationwide in the US and internationally to Australia, Canada, Germany, Italy, the UK, Great Britain, and Ireland. The source text does not specify the total number of units affected or report any illnesses or injuries. Users should verify the serial numbers of their accessory packages against the extensive list provided in the official recall notice to determine if they are affected.

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, 230 VOLTS AC, REF/Catalog Number 7-900-230, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Units. -- ASSEMBLED
Manufacturer
ConMed Corporation
Category
Medical Device — Surgical Accessories
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: 1640179
  • 15500473
  • 16090084
  • 16140185
  • 16170283
  • 16250376
  • 16370476
  • 16380489
  • 1640180
  • 15510474
  • 16090085
  • 16140186
  • 16170284
  • 16250377
  • 16370477
  • 16380490
  • 1640181
  • 15510475
  • 16090086
  • 16140187

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 →

Same hazard · sterility failure

See all →