Browse Device Recalls
2,055 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,055 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 2,055 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 29, 2023 | Alinity c Iron Reagent, Reference Number 08P3920 | A high recovery of Iron assay has been observed at some customer sites. Internal studies confirm... | Class II | Sentinel CH SpA |
| Sep 29, 2023 | IRON assay, Reference Numbers 6K95-41 and 6K95-30 | A high recovery of Iron assay has been observed at some customer sites. Internal studies confirm... | Class II | Sentinel CH SpA |
| Sep 25, 2023 | Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ure... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T. | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Mobile airway scope-diagnosis and observation to access airway anatomy, endot... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided ne... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Colonoscope: for endoscopy and endoscopic surgery within the lower digestive ... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Small intestinal videoscope-For endoscopy and endoscopic surgery within the u... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number:... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and oth... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Gastrointestinal videoscope-indicated for use within the upper digestive trac... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: H... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Tracheal videoscope- For airway management, which includes observation to acc... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Cystonephroscope-endoscopic diagnosis and treatment within the bladder, ureth... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidn... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasoun... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Colonoscope-indicated for use within the lower digestive tract (including the... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lum... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Bronchoscope-for endoscopy and endoscopic surgery within the airways and trac... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60. | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class III | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) a... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Tracheal fiberscope-airway management, which includes observation to access a... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower dig... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 18, 2023 | IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions wit... | The patient positioning system can perform motions in unexpected directions, creating the potenti... | Class II | Ion Beam Applications S.A. |
| Sep 13, 2023 | Astral 100 and Astral 150 ventilators | If ventilator is on internal battery, not intended to serve as a primary power source, low/critic... | Class I | ResMed Ltd. |
| Sep 12, 2023 | RayCare 5B and 6A including service packs- An oncology information system use... | An issue was found in RayCare 5B, 6A, including service packs, where values will not be visible f... | Class II | RAYSEARCH LABORATORIES AB |
| Sep 11, 2023 | Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural... | Infusion Pumps with affected software revision may fail to detect air in line, which may lead to ... | Class I | EITAN MEDICAL LTD |
| Sep 8, 2023 | F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms) | There is a potential interruption of data communication between E-modules inserted in the F2-01 F... | Class II | GE Medical Systems China Co., Ltd. |
| Sep 6, 2023 | RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (... | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee... | Class II | Randox Laboratories Ltd. |
| Sep 6, 2023 | AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solu... | The firm has identified that the Transferrin reagent does not meet the Instructions for Use (IFU)... | Class II | Beckman Coulter Biomedical Division |
| Sep 6, 2023 | RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: R... | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee... | Class II | Randox Laboratories Ltd. |
| Sep 6, 2023 | RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (re... | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee... | Class II | Randox Laboratories Ltd. |
| Sep 6, 2023 | RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000 | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee... | Class II | Randox Laboratories Ltd. |
| Sep 6, 2023 | RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000 | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee... | Class II | Randox Laboratories Ltd. |
| Sep 6, 2023 | Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2,... | Some Venue Go Standard Carts can develop an internal failure of the vertical/horizontal tilt adju... | Class II | GE MEDICAL SYSTEMS, ISRAEL LTD. |
| Sep 5, 2023 | MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 ... | Software update | Class II | Mazor Robotics Ltd |
| Aug 29, 2023 | PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product... | Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue,... | Class II | Limacorporate S.p.A |
| Aug 25, 2023 | Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19 | Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill ... | Class II | TECHNO-PATH MANUFACTURING LTD. |
| Aug 25, 2023 | Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12 | Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill ... | Class II | TECHNO-PATH MANUFACTURING LTD. |
| Aug 25, 2023 | Multichem P, Part Code 08P90-10 | Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill ... | Class II | TECHNO-PATH MANUFACTURING LTD. |
| Aug 23, 2023 | LFS Flat screen arm system with surgical lamp for Models Aurora series, Auror... | The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the ... | Class II | DKK Dai-Ichi Shomei Co., Ltd. |
| Aug 23, 2023 | LFS Flat screen support arm systems without surgical lamp for models Aurora s... | The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the ... | Class II | DKK Dai-Ichi Shomei Co., Ltd. |
| Aug 22, 2023 | therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Roto... | Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_... | Class II | Qiagen GmbH |
| Aug 18, 2023 | OPMI LUMERA 300, REF 6137 | Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, whic... | Class II | Carl Zeiss Suzhou Co., Ltd. |
| Aug 17, 2023 | SOZO Bilateral Arm L-Dex Software | Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect ea... | Class II | Impedimed Limited |
| Aug 17, 2023 | exoplan version 3.1 Rijeka Software -A medical software, intended to support ... | A software library filtering error has been discovered which occurs when users are using the Step... | Class II | Exocad GmbH |
| Aug 10, 2023 | Functional MR V1.0 | When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting mu... | Class II | OLEA MEDICAL |
| Aug 8, 2023 | Oculus Pentacam AXL Wave, Ref 70020, CE 0123 | Their is a potential that optical devices with insufficient anti-reflective coating may lead to... | Class II | Oculus Optikgeraete GMBH |
| Aug 8, 2023 | Oculus Myopia Master , Ref 68100, CE 0123 | Their is a potential that optical devices with insufficient anti-reflective coating may lead to... | Class II | Oculus Optikgeraete GMBH |
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.