ConMed CORE Suction Irrigation Handpiece Recalled for Packaging Seal Crease
ConMed is recalling CORE Suction Irrigation Handpieces because a crease in the packaging seal may create an open channel that compromises the product's sterility.
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 explicitly states no illnesses or injuries have been reported. The hazard is a theoretical risk of compromised sterility due to a packaging defect, which aligns with the criteria for a moderate severity score.
Plain-English summary
ConMed Corporation is recalling the CORE Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags, Catalog Number CD8302. The CORE Trumpet series (CD81XX, CD83XX, and CD84XX) is used in gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures. The recall covers units with lot codes beginning at 110609X and ending at 20160308X.
The recall is due to a potential crease in the packaging seal. This crease may result in an open channel, which could compromise the sterility of the product. The affected devices 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.
Healthcare facilities and users should stop using the affected devices and contact ConMed Corporation for instructions on return or replacement. The source text does not report any specific illnesses or injuries associated with this defect.
The recalled product
- Product
- CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags, Catalog Number CD8302 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
- 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 (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 →Related recalls
Same manufacturer · ConMed Corporation
See all →- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- HighConMed AirSeal 12mm blunt tip 100mm 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 8mm 100mm optical obturator ports may trigger overpressure alerts
FDA (Devices) · 2026-06-24
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighConMed Anchor Tissue Retrieval System Recalled for Seal Defects
FDA (Devices) · 2019-05-15
- HighConMed Anchor Tissue Retrieval System Recalled for Sterility Seal Defects
FDA (Devices) · 2019-05-15
- HighConMed Recalls UltraClean Accessory Electrodes Due to Compromised Sterile Seals
FDA (Devices) · 2013-01-30
- HighConMed Recalls TUR Endoscopic Cables Due to Compromised Sterile Pouch Seals
FDA (Devices) · 2013-01-30
- ModerateConMed Recalls UltraClean Accessory Electrode Due to Compromised Sterile Seals
FDA (Devices) · 2013-01-30
- HighConMed Linvatec Recalls APEX Arthroscopy Tubing Sets Due to Pressure Fitting Defect
FDA (Devices) · 2013-07-17