Browse Device Recalls
2,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,276 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 2,276 FDA device recalls in 2022.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 11, 2022 | 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019... | Due to an increase in complaint trend for leaks and intermittent/loose connections. | Class II | Abbott Vascular |
| Mar 11, 2022 | Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems | There is a quality issue with the three bolts that hold the CT balancing weights, which could cre... | Class II | Siemens Medical Solutions USA, Inc. |
| Mar 11, 2022 | Total Resources International First Aid Kits, Item Numbers: 10HBC01087, 10HBC... | ULTRAtab Laboratories recalled Acetaminophen and electrolyte tablets that were later placed into ... | Class II | Total Resources Intl |
| Mar 11, 2022 | 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01) | Due to an increase in complaint trend for leaks and intermittent/loose connections. | Class II | Abbott Vascular |
| Mar 11, 2022 | VELYS Robotic-Assisted Solution Base Product No.: 451570100 | System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) cha... | Class II | DePuy Orthopaedics, Inc. |
| Mar 11, 2022 | Total Resources International First Aid Kits, Item Numbers: 01REF2621, 10OUT0... | ULTRAtab Laboratories recalled Acetaminophen and electrolyte tablets that were later placed into ... | Class II | Total Resources Intl |
| Mar 11, 2022 | INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01) | Due to an increase in complaint trend for leaks and intermittent/loose connections. | Class II | Abbott Vascular |
| Mar 11, 2022 | Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Pl... | Due to an increase in complaint trend for leaks and intermittent/loose connections. | Class II | Abbott Vascular |
| Mar 11, 2022 | Virus Counter Platform with Model Name VC3100 | The Virus Counter is an automated laboratory instrument that enables rapid quantification of inta... | Class II | Sartorius Corporation |
| Mar 10, 2022 | Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q | Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to e... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Mar 10, 2022 | Merlin PCS 3650 programmer Model 3330 software | Due to a programmer software anomaly under very specific circumstance when executing a pacing cap... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Mar 10, 2022 | EasyFuse Dynamic Compression System Instrument Pack | The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide b... | Class II | Wright Medical Technology, Inc. |
| Mar 10, 2022 | Merlin 2 PCS MER3700 programmer Model MER3400 software | Due to a programmer software anomaly under very specific circumstance when executing a pacing cap... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Mar 10, 2022 | Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q | Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to e... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Mar 10, 2022 | Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q | Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to e... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Mar 9, 2022 | RocheDiabetes Care Platform Software version 2.5.2 material number 0888835300... | Potential for patient data mismatch when using browser "back" button to navigate between patients... | Class II | Roche Diabetes Care, Inc. |
| Mar 9, 2022 | 4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012 | Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength f... | Class II | Acumed LLC |
| Mar 9, 2022 | 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010 | Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength f... | Class II | Acumed LLC |
| Mar 9, 2022 | BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Softwar... | When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set b... | Class II | Becton Dickinson & Co. |
| Mar 9, 2022 | Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box | The mask cuff may disconnect from the device's breathing tube. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 8, 2022 | Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8... | Product was improperly store which may cause a delay in results. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 8, 2022 | ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myogl... | This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a cal... | Class II | Abbott Laboratories |
| Mar 8, 2022 | OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143 | Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of h... | Class II | SIMPLIVIA HEALTHCARE LTD. |
| Mar 8, 2022 | Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes conta... | The product was stored incorrectly due to improper storage controls which may lead to delayed res... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 8, 2022 | BF-1TQ180: EVIS EXERA II Bronchovideoscope | Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessin... | Class II | Olympus Corporation of the Americas |
| Mar 8, 2022 | BF-MP60: OES Bronchofiberscope | Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessin... | Class II | Olympus Corporation of the Americas |
| Mar 8, 2022 | ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support | Pouch seals may be open, compromising sterility. | Class II | Boston Scientific Corporation |
| Mar 8, 2022 | ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy | Pouch seals may be open, compromising sterility. | Class II | Boston Scientific Corporation |
| Mar 8, 2022 | BF-MP160F: EVIS EXERA Bronchofibervideoscope | Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessin... | Class II | Olympus Corporation of the Americas |
| Mar 8, 2022 | BF-3C160: EVIS EXERA Bronchovideoscope | Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessin... | Class II | Olympus Corporation of the Americas |
| Mar 7, 2022 | YSIO X.Pree | For the automated multi-image-acquisition procedure Ortho x-ray collimation is set in a preparati... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 7, 2022 | syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Mod... | Upgraded software version makes an automatic change in laser configuration settings for "markerle... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 7, 2022 | syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Nu... | Upgraded software version makes an automatic change in laser configuration settings for "markerle... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 7, 2022 | syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number ... | Upgraded software version makes an automatic change in laser configuration settings for "markerle... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 7, 2022 | syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Num... | Upgraded software version makes an automatic change in laser configuration settings for "markerle... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 7, 2022 | SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now ... | Software error may result in sporadic problems causing scanning workflow interruptions, unexpecte... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 7, 2022 | Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only , | Transducers (component of ultrasound system) may exceed recommended thermal index limits | Class II | Siemens Medical Solutions USA, Inc. |
| Mar 4, 2022 | Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVI... | The product was distributed without FDA authorization or clearance for marketing and distribution... | Class I | SML Distribution, LLC |
| Mar 4, 2022 | Alinity m HBV Application Specification File (US and CE) | There is a potential for misquantitation high results of negative samples. | Class II | Abbott Molecular, Inc. |
| Mar 4, 2022 | Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride In... | Sterility failure of the exterior of the syringe which may impact the device's ability to be laid... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 4, 2022 | GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier,... | During the de-installation of an MR system magnet, if all rigging and hardware that attach to the... | Class II | GE Healthcare, LLC |
| Mar 4, 2022 | Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. F... | Software issue resulting in temporary loss of central monitoring functionality. | Class II | Draegar Medical Systems, Inc. |
| Mar 4, 2022 | First SIGN SARS-CoV-2 Antigen Test | Frm became aware that a customer complaint was reported to US FDA that SARS-CoV-2 Antigen Tests w... | Class II | WHPM Inc. |
| Mar 4, 2022 | Alinity m HBV AMP Kit (US and CE) | There is a potential for misquantitation high results for negative samples. | Class II | Abbott Molecular, Inc. |
| Mar 3, 2022 | Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the qu... | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 3, 2022 | ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the ... | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 3, 2022 | EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended U... | Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known... | Class II | Boston Scientific Corporation |
| Mar 3, 2022 | DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhex... | A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods... | Class II | DeRoyal Industries Inc |
| Mar 3, 2022 | EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Us... | Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known... | Class II | Boston Scientific Corporation |
| Mar 3, 2022 | Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the qu... | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret p... | Class II | Siemens Healthcare Diagnostics, Inc. |
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.