Browse Device Recalls

82 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 82 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 82 FDA device recalls.

Clear

Date	Product	Reason	Class	Firm
Aug 28, 2024	Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ...	CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable En...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Jun 25, 2024	1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3...	The tube may fall into the surgical site during the grasping process.	Class II	UNIMAX MEDICAL SYSTEMS INC
Nov 18, 2022	Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction C...	Suction ports may potentially be occluded on the affected devices. If this occurs, the affected d...	Class II	ConMed Corporation
Mar 26, 2021	INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibia...	Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide syst...	Class II	ConMed Corporation
Mar 26, 2021	KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibi...	Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide syst...	Class II	ConMed Corporation
Nov 12, 2020	Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic pr...	Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which c...	Class II	ConMed Corporation
Nov 12, 2020	Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic pr...	Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which c...	Class II	ConMed Corporation
Mar 21, 2019	ConMed Anchor Tissue Retrieval System", 12 MM, 300 ML (5/BX) Catalog Number:...	Voids in the seal or a partial seal results in an open channel and may compromise the sterility o...	Class II	Conmed Corporation
Mar 21, 2019	ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TR...	Voids in the seal or a partial seal results in an open channel and may compromise the sterility o...	Class II	Conmed Corporation
Mar 21, 2019	ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:...	Voids in the seal or a partial seal results in an open channel and may compromise the sterility o...	Class II	Conmed Corporation
Mar 21, 2019	ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog N...	Voids in the seal or a partial seal results in an open channel and may compromise the sterility o...	Class II	Conmed Corporation
Mar 21, 2019	ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: ...	Voids in the seal or a partial seal results in an open channel and may compromise the sterility o...	Class II	Conmed Corporation
Mar 21, 2019	ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: ...	Voids in the seal or a partial seal results in an open channel and may compromise the sterility o...	Class II	Conmed Corporation
Feb 23, 2018	MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, ...	Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede ...	Class II	ConMed Corporation
Feb 23, 2018	MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog N...	Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede ...	Class II	ConMed Corporation
Feb 23, 2018	MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, ...	Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede ...	Class II	ConMed Corporation
Feb 23, 2018	MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, ...	Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede ...	Class II	ConMed Corporation
Feb 23, 2018	MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Co...	Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede ...	Class II	ConMed Corporation
Jun 19, 2017	STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets ...	Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.	Class II	ConMed Corporation
Jun 19, 2017	STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administr...	Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.	Class II	ConMed Corporation
Apr 17, 2017	Nonabsorbable suture anchor system intended to reattach soft tissue to bone i...	Manufactured with the incorrect anchor outer body	Class II	ConMed Corporation
Feb 28, 2017	Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages c...	For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error...	Class II	ConMed Corporation
Feb 28, 2017	Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages c...	For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error...	Class II	ConMed Corporation
Feb 28, 2017	Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages c...	For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error...	Class II	ConMed Corporation
Feb 28, 2017	Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages c...	For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error...	Class II	ConMed Corporation
Feb 28, 2017	HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE,...	For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error...	Class II	ConMed Corporation
Aug 29, 2016	CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-02...	CONMED received complaints of damage to the CS-023 electrodes shaft insulation which could resul...	Class II	ConMed Corporation
Jun 27, 2016	CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 ...	The packaging seal may contain a crease. The crease may result in an open channel. These channel...	Class II	ConMed Corporation
Jun 27, 2016	CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe...	The packaging seal may contain a crease. The crease may result in an open channel. These channel...	Class II	ConMed Corporation
Jun 27, 2016	CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual ...	The packaging seal may contain a crease. The crease may result in an open channel. These channel...	Class II	ConMed Corporation
Jun 27, 2016	CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX...	The packaging seal may contain a crease. The crease may result in an open channel. These channel...	Class II	ConMed Corporation
Jun 27, 2016	CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single So...	The packaging seal may contain a crease. The crease may result in an open channel. These channel...	Class II	ConMed Corporation
Jun 27, 2016	CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Ca...	The packaging seal may contain a crease. The crease may result in an open channel. These channel...	Class II	ConMed Corporation
Jun 27, 2016	CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single So...	The packaging seal may contain a crease. The crease may result in an open channel. These channel...	Class II	ConMed Corporation
May 18, 2016	Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Bi...	A version of the dual dispersive electrodes may not be compatible with some electrosurgical gener...	Class II	Conmed Corporation
May 18, 2016	Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtche...	A version of the dual dispersive electrodes may not be compatible with some electrosurgical gener...	Class II	Conmed Corporation
May 18, 2016	Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable...	A version of the dual dispersive electrodes may not be compatible with some electrosurgical gener...	Class II	Conmed Corporation
May 18, 2016	Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.), 10'...	A version of the dual dispersive electrodes may not be compatible with some electrosurgical gener...	Class II	Conmed Corporation
May 18, 2016	Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.0...	A version of the dual dispersive electrodes may not be compatible with some electrosurgical gener...	Class II	Conmed Corporation
Dec 21, 2015	Hip Preservation System Signature Series PreBent Burs under the following lab...	Metal shavings released from burs during use are due to contact between the bur and the hood of t...	Class II	ConMed Corporation
Nov 5, 2015	Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 ...	Miscalibration of the Energy Source monitoring function, which may incorrectly sense the handpiec...	Class II	ConMed Corporation
Jun 17, 2015	Arthroscopic Energy 50¿ Probe with Suction, Catalog number: AES-50S Peoduc...	Probe programming error. The incorrect program can generate more heat at the surgical site, resu...	Class II	ConMed Corporation
Nov 6, 2014	CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direc...	Philips Healthcare made changes to the design of the connection between multifunction electrodes ...	Class I	ConMed Corporation
Nov 6, 2014	ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPA...	Philips Healthcare made changes to the design of the connection between multifunction electrodes ...	Class I	ConMed Corporation
Nov 6, 2014	ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- CO...	Philips Healthcare made changes to the design of the connection between multifunction electrodes ...	Class I	ConMed Corporation
Nov 6, 2014	PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H, Rx ONLY --- C...	Philips Healthcare made changes to the design of the connection between multifunction electrodes ...	Class I	ConMed Corporation
Nov 6, 2014	ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- CO...	Philips Healthcare made changes to the design of the connection between multifunction electrodes ...	Class I	ConMed Corporation
Nov 6, 2014	ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COM...	Philips Healthcare made changes to the design of the connection between multifunction electrodes ...	Class I	ConMed Corporation
Nov 6, 2014	CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, D...	Philips Healthcare made changes to the design of the connection between multifunction electrodes ...	Class I	ConMed Corporation
Nov 6, 2014	MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY ...	Philips Healthcare made changes to the design of the connection between multifunction electrodes ...	Class I	ConMed Corporation

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.