Conmed Corporation
FDA Regulatory Profile
Conmed Corporation appears in FDA public data with 92 recalls — including 9 Class I (most serious) —, 83 510(k) clearances, 17 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-3018-2026, Class II) was initiated on July 14, 2026. Its most recent 510(k) clearance was granted on May 13, 2026.
Summary
- Total Recalls
- 92 (9 Class I)
- 510(k) Clearances
- 83
- Inspections
- 17
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3018-2026 | Class II | CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESY | July 14, 2026 |
| Z-2473-2026 | Class II | ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. | May 14, 2026 |
| Z-2468-2026 | Class II | ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. C | May 14, 2026 |
| Z-2467-2026 | Class II | ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. C | May 14, 2026 |
| Z-2465-2026 | Class II | ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12- | May 14, 2026 |
| Z-2471-2026 | Class II | ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. C | May 14, 2026 |
| Z-2466-2026 | Class II | ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-1 | May 14, 2026 |
| Z-2474-2026 | Class II | ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length. Ca | May 14, 2026 |
| Z-2470-2026 | Class II | ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. C | May 14, 2026 |
| Z-2472-2026 | Class II | ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm Length. Ca | May 14, 2026 |
| Z-2464-2026 | Class II | ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length. Catalog Number: i | May 14, 2026 |
| Z-2469-2026 | Class II | ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length. Ca | May 14, 2026 |
| Z-0474-2023 | Class II | Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog | November 18, 2022 |
| Z-1499-2021 | Class II | KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibial Elbow and Tip Guides | March 26, 2021 |
| Z-1498-2021 | Class II | INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides | March 26, 2021 |
| Z-0650-2021 | Class II | Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligam | November 12, 2020 |
| Z-0651-2021 | Class II | Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligam | November 12, 2020 |
| Z-1307-2019 | Class II | ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog Number: TRS-VATS-15 | March 21, 2019 |
| Z-1306-2019 | Class II | ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:TRS190SB2 The Ancho | March 21, 2019 |
| Z-1304-2019 | Class II | ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 The Ancho | March 21, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261363 | Y-Knotless Flex Anchors | May 13, 2026 |
| K253763 | Y-Knotless Flex Anchors | January 29, 2026 |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit | October 15, 2025 |
| K251530 | CONMED Argo Knotless® Anchor | June 18, 2025 |
| K250395 | BioBrace ® RC Delivery System | April 7, 2025 |
| K244025 | Argo Knotless GENESYS Anchor | January 28, 2025 |
| K242187 | BioBrace® | November 27, 2024 |
| K240127 | PlumeSafe X5 Smoke Management System | August 5, 2024 |
| K241906 | BioBrace® Reinforced Implant | July 29, 2024 |
| K240090 | Argo Knotless GENESYS Anchor | March 5, 2024 |
| K231732 | CleanSeal Advanced Bipolar Vessel Sealer Maryland | October 23, 2023 |
| K230239 | AirSeal iFS System; AirSeal dV Solution | September 20, 2023 |
| K230547 | PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, Plu | April 27, 2023 |
| K214058 | Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired | August 26, 2022 |
| K221945 | Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE | July 28, 2022 |
| K220186 | Zone Specific AIM | May 13, 2022 |
| K220757 | Argo Knotless SP Anchor | May 13, 2022 |
| K213354 | Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify | March 11, 2022 |
| K211104 | AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set | August 19, 2021 |
| K202303 | CORE E3 Suction/irrigator | February 19, 2021 |