Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0130-2017·Announced 2016-10-26

ConMed Recalls CORE Suction Irrigation Handpieces Due to Packaging Seal Defects

ConMed Corporation is recalling CORE Suction Irrigation Handpieces because packaging seal creases may compromise sterility. The recall covers units distributed in the US and internationally.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

ConMed Corporation is recalling CORE Suction Irrigation Handpieces with 5mm x 32cm Length Probes for Single Solution or Dual Bags (Catalog Number CD8190). The recall also includes the CORE Trumpet series (CD81XX, CD83XX, and CD84XX), which are used in gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures. The affected lot codes range from 110609X to 20160308X.

The recall was initiated because the packaging seal may contain a crease. This crease may result in an open channel that compromises the sterility of the product. The agency has classified this as a Class II recall.

The affected products were distributed nationwide in the United States and internationally to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, the United Kingdom, Guatemala, the Czech Republic, and Canada. Users should stop using the affected devices and contact ConMed Corporation for further instructions.

The recalled product

Product: CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8190 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
Manufacturer: ConMed Corporation
Category: Medical Device — Surgical Instruments
Hazard: sterility-compromise
packaging-defect

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 (1)

Beginning Lot Code 110609X to Ending Lot Code 20160308X

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 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 7 products in this recall →

Same manufacturer · ConMed Corporation

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Same hazard · sterility compromise