CLASS II Device recall · Reported 21 Dec 2022 · FDA Enforcement Report
Foot Controlled Electrosurgical Suction Coagulator recalled by ConMed
ConMed is recalling Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator, distributed nationwide in the US. The recall was initiated on 18 Nov 2022 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-0474-2023
- FDA event ID
- 91165
- Recalling firm
- ConMed, Utica, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Nov 2022
- FDA classified
- 9 Dec 2022
- Reported
- 21 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 18 Nov 2022 | Recall initiated by company | |
| 9 Dec 2022 | Classified by FDA | +21 days |
| 21 Dec 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device to be used.
Product as listed by the FDA
Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187
Where it was distributed
Domestic distribution nationwide. Foreign distribution to Colombia, Ecuador, Nicaragua, Panama, Thailand, Australia, Canada, and Lebanon.
Questions about this recall
Is Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator recalled?
Yes. ConMed recalled Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator on 18 Nov 2022. The recall is Class II and its status is Terminated. Recall number Z-0474-2023.
Why was it recalled?
Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device to be used.
Which lots are affected?
UDI-DI: 30653405059930 Lot codes 202204294 202205134 202205164 202206084 202206154 202206204 202206304 202207074 202207084 202208014 202208044 202208084
Where was it sold?
Domestic distribution nationwide. Foreign distribution to Colombia, Ecuador, Nicaragua, Panama, Thailand, Australia, Canada, and Lebanon.
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 |