ConMed CORE Trumpet Handpiece Recalled for Potential Sterility Compromise
ConMed is recalling CORE Trumpet Handpieces because packaging creases may create open channels that compromise 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 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 (sterile medical device) where the hazard is a potential sterility compromise, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
ConMed Corporation is recalling the CORE Trumpet Handpiece, Catalog Number CD8450. The recall is due to a potential defect in the packaging seal, which may contain a crease. This crease could result in an open channel that compromises the sterility of the product.
The affected product is used in gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures. The recall covers units with lot codes beginning with 110609X and ending with 20160308X. The product was 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 providers and facilities should stop using the affected handpieces and contact ConMed Corporation for instructions on how to return or replace the product.
The recalled product
- Product
- CORE¿ Trumpet Handpiece only, Catalog Number CD8450 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
- HighMedtronic Disposable Gloves Recalled for Potential Sterility Compromise
FDA (Devices) · 2017-03-08
- HighMedtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise
FDA (Devices) · 2016-08-24
- HighConMed Recalls UltraClean Accessory Electrodes Due to Compromised Sterile Seals
FDA (Devices) · 2013-01-30
- HighConMed Recalls Goldvac UltraClean Accessory Electrode Due to Compromised Sterile Seals
FDA (Devices) · 2013-01-30