Browse Device Recalls
706 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 706 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 706 FDA device recalls in GA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Feb 3, 2023 | Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 1224... | Incorrect expiration date. | Class II | Avanos Medical, Inc. |
| Feb 3, 2023 | BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold. | Potential for product manifold to crack during use on patients, possibly causing leaks in the res... | Class I | Avanos Medical, Inc. |
| Feb 3, 2023 | BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold. | Potential for product manifold to crack during use on patients, possibly causing leaks in the res... | Class I | Avanos Medical, Inc. |
| Dec 5, 2022 | Oncentra Brachy radiation therapy planning system software. | A reconstruction error may occur when using the Catheter Bending functionality in Applicator Mode... | Class II | Elekta, Inc. |
| Dec 2, 2022 | Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-182... | The stylet is longer than specified on the label | Class II | Remington Medical, Inc. |
| Nov 2, 2022 | HENRY SCHEIN, ILR Insertion Tray, Item No.570-3131 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, BREAST PACK, Item No.570-2397 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dental | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery ... | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Ablation Pack, Item No.682-130, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, GYN PACK, Item No.570-2625 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
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.