Browse Device Recalls

672 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 672 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 672 FDA device recalls in GA.

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DateProductReasonClassFirm
Dec 20, 2023 Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ ... BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... Class II C.R. Bard Inc
Dec 20, 2023 Bard¿ Suction Connector with ENFit, REF EN0066000 BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... Class II C.R. Bard Inc
Dec 20, 2023 Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100 BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... Class II C.R. Bard Inc
Dec 20, 2023 Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000 BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... Class II C.R. Bard Inc
Dec 20, 2023 Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr... BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... Class II C.R. Bard Inc
Dec 20, 2023 Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ ... BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... Class II C.R. Bard Inc
Dec 20, 2023 Bard¿ Lopez Valve¿ with ENFit, REF EN0056000 BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... Class II C.R. Bard Inc
Dec 20, 2023 Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr... BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... Class II C.R. Bard Inc
Dec 20, 2023 Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12F... BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... Class II C.R. Bard Inc
Dec 20, 2023 Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, ... BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... Class II C.R. Bard Inc
Dec 20, 2023 Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr... BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... Class II C.R. Bard Inc
Dec 20, 2023 Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180 BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... Class II C.R. Bard Inc
Dec 20, 2023 Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr... BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... Class II C.R. Bard Inc
Dec 20, 2023 Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140 BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... Class II C.R. Bard Inc
Nov 17, 2023 VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number... Cassette did not meet an 1n-process flow criterion. Class II Vero Biotech, LLC
Nov 15, 2023 Sensica Urine Output System, Catalog Number SCCS1002 BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/... Class II C.R. Bard Inc
Nov 3, 2023 Remington MEDICAL Drainage Bag, REF 600-D; There is an error with the "Use by Date" and "Date of Manufacturer" on the box label. Class II Remington Medical, Inc.
Oct 25, 2023 ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical C... Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i... Class II Elekta, Inc.
Oct 25, 2023 ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Partic... Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i... Class II Elekta, Inc.
Oct 25, 2023 ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation T... Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i... Class II Elekta, Inc.
Oct 25, 2023 ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiati... Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i... Class II Elekta, Inc.
Oct 25, 2023 ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charg... Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i... Class II Elekta, Inc.
Oct 25, 2023 ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; M... Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i... Class II Elekta, Inc.
Oct 13, 2023 AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product cod... Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not bei... Class II Avanos Medical, Inc.
Oct 4, 2023 CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used fo... Potential for damaged and frayed power connector plug with repeated bending or manipulation beyon... Class II St. Jude Medical
Aug 1, 2023 COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four i... Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing ... Class II Avanos Medical, Inc.
Jul 7, 2023 procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿... Ultrasound gel mislabeled with inappropriate use. Class II Advance Medical Designs, Inc.
Jul 7, 2023 Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 2... Ultrasound gel mislabeled with inappropriate use. Class II Advance Medical Designs, Inc.
Jul 7, 2023 Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20... Ultrasound gel mislabeled with inappropriate use. Class II Advance Medical Designs, Inc.
Jul 7, 2023 Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 2... Ultrasound gel mislabeled with inappropriate use. Class II Advance Medical Designs, Inc.
Jul 7, 2023 50-GEL20; Ultrasound gel Ultrasound gel mislabeled with inappropriate use. Class II Advance Medical Designs, Inc.
Jul 7, 2023 ASG-001; Ultrasound gel Ultrasound gel mislabeled with inappropriate use. Class II Advance Medical Designs, Inc.
May 5, 2023 Elekta Medical Linear Accelerator (ELMA) included in the below platforms: ... A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC... Class II Elekta, Inc.
Apr 24, 2023 AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507 Some of the ambIT kits were potentially distributed without an air in-line filter. Class II Avanos Medical, Inc.
Apr 24, 2023 SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568 Some of the ambIT kits were potentially distributed without an air in-line filter. Class II Avanos Medical, Inc.
Apr 24, 2023 ambIT Cassette Filter Male Luer, Product Code: 220266 Some of the ambIT kits were potentially distributed without an air in-line filter. Class II Avanos Medical, Inc.
Apr 24, 2023 SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537 Some of the ambIT kits were potentially distributed without an air in-line filter. Class II Avanos Medical, Inc.
Apr 24, 2023 AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509 Some of the ambIT kits were potentially distributed without an air in-line filter. Class II Avanos Medical, Inc.
Apr 20, 2023 Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G... Some catheters had a manufacturing defect where the clear resealing label separating from the pro... Class II C.R. Bard Inc
Apr 20, 2023 Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 5... Some catheters had a manufacturing defect where the clear resealing label separating from the pro... Class II C.R. Bard Inc
Apr 20, 2023 Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 5180... Some catheters had a manufacturing defect where the clear resealing label separating from the pro... Class II C.R. Bard Inc
Apr 20, 2023 HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b... Some catheters had a manufacturing defect where the clear resealing label separating from the pro... Class II C.R. Bard Inc
Apr 6, 2023 Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient ... There is a low possibility that an electrical connector in the MR gradient coil will overheat on ... Class II Elekta, Inc.
Feb 7, 2023 CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, T... Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Model... Class II St. Jude Medical
Feb 7, 2023 CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The ... Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at hi... Class II St. Jude Medical
Feb 7, 2023 CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, T... Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Model... Class II St. Jude Medical
Feb 7, 2023 CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, T... Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Model... Class II St. Jude Medical
Feb 7, 2023 CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, ... Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Model... Class II St. Jude Medical
Feb 7, 2023 CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The ... Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at hi... Class II St. Jude Medical
Feb 7, 2023 CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The ... Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at hi... Class II St. Jude Medical

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.