Conmed recalls
Conmed appears in 92 official U.S. recall notices indexed by RecallRadar, most recently on 2026-09-02.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 92 |
|---|---|
| Published | 2012-12-19 to 2026-09-02 |
| By agency | FDA Device (92) |
| By classification | Class II (83), Class I (9) |
| By status | terminated (80), ongoing (12) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, US, UT, VA, WA, WI, WV, WY |
Recalls
- CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor with two, #2 (5 me…
FDA Device · Class II · 2026-09-02 · Conmed
Reason: Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability. - ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length
FDA Device · Class II · 2026-06-24 · Conmed
Reason: Potential for overpressure alerts. - ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm Length
FDA Device · Class II · 2026-06-24 · Conmed
Reason: Potential for overpressure alerts. - ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length
FDA Device · Class II · 2026-06-24 · Conmed
Reason: Potential for overpressure alerts. - ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length
FDA Device · Class II · 2026-06-24 · Conmed
Reason: Potential for overpressure alerts. - ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length
FDA Device · Class II · 2026-06-24 · Conmed
Reason: Potential for overpressure alerts. - ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length
FDA Device · Class II · 2026-06-24 · Conmed
Reason: Potential for overpressure alerts. - ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length
FDA Device · Class II · 2026-06-24 · Conmed
Reason: Potential for overpressure alerts. - ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length
FDA Device · Class II · 2026-06-24 · Conmed
Reason: Potential for overpressure alerts. - ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length
FDA Device · Class II · 2026-06-24 · Conmed
Reason: Potential for overpressure alerts. - ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length
FDA Device · Class II · 2026-06-24 · Conmed
Reason: Potential for overpressure alerts. - ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length
FDA Device · Class II · 2026-06-24 · Conmed
Reason: Potential for overpressure alerts. - Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187
FDA Device · Class II · 2022-12-21 · Conmed
Reason: 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 requi… - KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100
FDA Device · Class II · 2021-05-05 · Conmed
Reason: Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another device or alternate surgical method to be used - INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100
FDA Device · Class II · 2021-05-05 · Conmed
Reason: Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another device or alternate surgical method to be used - Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction
FDA Device · Class II · 2020-12-30 · Conmed
Reason: Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system - Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction
FDA Device · Class II · 2020-12-30 · Conmed
Reason: Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system - ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 The Anchor Tissue Retrieval System" by CONMED is a st…
FDA Device · Class II · 2019-05-15 · Conmed
Reason: Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product - ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog Number: TRS-VATS-15 The Anchor Tissue Retrieval System" by CONME…
FDA Device · Class II · 2019-05-15 · Conmed
Reason: Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product - ConMed Anchor Tissue Retrieval System", 12 MM, 300 ML (5/BX) Catalog Number: TRS-ROBO-12 The Anchor Tissue Retrieval System" by CONMED is a…
FDA Device · Class II · 2019-05-15 · Conmed
Reason: Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product - ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: TRS175SB2 The Anchor Tissue Retrieval System" by CONMED is a st…
FDA Device · Class II · 2019-05-15 · Conmed
Reason: Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product - ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:TRS190SB2 The Anchor Tissue Retrieval System" by CONMED is a st…
FDA Device · Class II · 2019-05-15 · Conmed
Reason: Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product - ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TRS-ROBO-8 The Anchor Tissue Retrieval System" by CONMED is a ste…
FDA Device · Class II · 2019-05-15 · Conmed
Reason: Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product - MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing,…
FDA Device · Class II · 2018-04-04 · Conmed
Reason: Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure - MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillati…
FDA Device · Class II · 2018-04-04 · Conmed
Reason: Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure - MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pacing,…
FDA Device · Class II · 2018-04-04 · Conmed
Reason: Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure - MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in externa…
FDA Device · Class II · 2018-04-04 · Conmed
Reason: Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure - MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing,…
FDA Device · Class II · 2018-04-04 · Conmed
Reason: Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure - STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets (Catalog Numbers: (1) S2-12 N, STAT 2¿ Exte…
FDA Device · Class II · 2018-03-07 · Conmed
Reason: Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates. - STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and Extension Sets (Catalog Numbers: (1) S2, STAT 2…
FDA Device · Class II · 2018-03-07 · Conmed
Reason: Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates. - Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthros…
FDA Device · Class II · 2017-12-20 · Conmed
Reason: Manufactured with the incorrect anchor outer body - Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) car…
FDA Device · Class II · 2017-04-19 · Conmed
Reason: For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could c… - HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single Patient Use -- CONMED CORPORATION, 525 FRENCH ROAD UTI…
FDA Device · Class II · 2017-04-19 · Conmed
Reason: For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could c… - Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) car…
FDA Device · Class II · 2017-04-19 · Conmed
Reason: For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could c… - Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) car…
FDA Device · Class II · 2017-04-19 · Conmed
Reason: For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could c… - Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) car…
FDA Device · Class II · 2017-04-19 · Conmed
Reason: For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could c… - CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Catalog Number CD8300 The CORE Trumpet (CD81XX, CD83XX, and CD84…
FDA Device · Class II · 2016-10-26 · Conmed
Reason: The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product. - CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8200 The C…
FDA Device · Class II · 2016-10-26 · Conmed
Reason: The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product. - CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparos…
FDA Device · Class II · 2016-10-26 · Conmed
Reason: The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product. - CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8190 The CORE Trumpet (C…
FDA Device · Class II · 2016-10-26 · Conmed
Reason: The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product. - CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications…
FDA Device · Class II · 2016-10-26 · Conmed
Reason: The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product. - CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags, Catalog Number CD8302 The CORE Trumpet (CD81XX, CD83XX,…
FDA Device · Class II · 2016-10-26 · Conmed
Reason: The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product. - CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags, Catalog Number CD8185 The CORE Trumpet (CD81XX, C…
FDA Device · Class II · 2016-10-26 · Conmed
Reason: The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product. - CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only Product Usage: The HeatWave Electrode is i…
FDA Device · Class II · 2016-10-19 · Conmed
Reason: CONMED received complaints of damage to the CS-023 electrodes shaft insulation which could result in burn marks on the shaft. If the shaft insulation is damaged in any way, it could increase the risk of patient burn. - Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400,…
FDA Device · Class II · 2016-08-31 · Conmed
Reason: A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn. - Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000,…
FDA Device · Class II · 2016-08-31 · Conmed
Reason: A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn. - Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410
FDA Device · Class II · 2016-08-31 · Conmed
Reason: A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn. - Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710
FDA Device · Class II · 2016-08-31 · Conmed
Reason: A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn. - Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) Cable, Catalog Number 51-7310
FDA Device · Class II · 2016-08-31 · Conmed
Reason: A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn. - Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm Catalog Number HPS…
FDA Device · Class II · 2016-06-08 · Conmed
Reason: Metal shavings released from burs during use are due to contact between the bur and the hood of the PreBent Bur assembly. During the manufacturing process an assembly error occurred which caused inadvertent mixing of tw…