CLASS II Device recall · Reported 26 Oct 2016 · FDA Enforcement Report
CORE¿ Trumpet Handpiece only recalled by ConMed
ConMed is recalling CORE¿ Trumpet Handpiece only, distributed nationwide in the US. The recall was initiated on 27 Jun 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0135-2017
- FDA event ID
- 74774
- Recalling firm
- ConMed, Utica, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jun 2016
- FDA classified
- 18 Oct 2016
- Reported
- 26 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- E. coli
- Device type
- Surgical Instruments
Timeline
| 27 Jun 2016 | Recall initiated by company | |
| 18 Oct 2016 | Classified by FDA | +113 days |
| 26 Oct 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
Some strains of E. coli, such as O157:H7, produce a toxin that can cause severe stomach cramps, bloody diarrhea and, in a small number of cases, kidney failure.
Product as listed by the FDA
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
Where it was distributed
Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.
Questions about this recall
Is CORE¿ Trumpet Handpiece only recalled?
Yes. ConMed recalled CORE¿ Trumpet Handpiece only on 27 Jun 2016. The recall is Class II and its status is Terminated. Recall number Z-0135-2017.
Why was it recalled?
The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
Which lots are affected?
Beginning Lot Code 110609X to Ending Lot Code 20160308X
Where was it sold?
Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from ConMed
All 92| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |
| Device | CLASS II | AirSeal Access Port and Palm Grip Obturator recalled by ConMed | ConMed | Packaging Defects | Nationwide |
| Device | CLASS II | AirSeal Access Port and Obturator with Blunt Tip Length recalled | ConMed | Packaging Defects | Nationwide |
| Device | CLASS II | AirSeal Access Port and Low Profile Obturator recalled by ConMed | ConMed | Packaging Defects | Nationwide |
| Device | CLASS II | AirSeal Access Port and Low Profile Obturator recalled by ConMed | ConMed | Packaging Defects | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |