Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 21, 2024 | Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary ... | Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intra... | Class I | Percussionaire Corporation |
| Aug 20, 2024 | Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: ... | Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar ... | Class II | Ossur H / F |
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use i... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Aug 20, 2024 | Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008 | Due to a classification error in our inventory management system, these medical devices were ship... | Class II | Cypress Medical Products LLC |
| Aug 20, 2024 | BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025 | Due to a classification error in our inventory management system, these medical devices were ship... | Class II | Cypress Medical Products LLC |
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a ... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a phar... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Aug 19, 2024 | Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Versio... | Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when use... | Class II | Hologic Inc |
| Aug 19, 2024 | IntelliSystem Inflation Device, REF: IN1525/D | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | StabiliT TOUCH Syringe, REF: IN8VCF/B | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | basixTOUCH Inflation Device, REF: IN8140/A | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | BlueFIRE Inflation Device, REF: IN10140 | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7... | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | basixSKY Inflation Device, REF: SKY1802 | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K0... | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, I... | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 16, 2024 | Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health... | Due to convenience kits containing a kit component that is under a recall action for improper use. | Class II | Windstone Medical Packaging, Inc. |
| Aug 16, 2024 | Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Sa... | Due to convenience kits containing a kit component that is under a recall action for improper use. | Class II | Windstone Medical Packaging, Inc. |
| Aug 16, 2024 | Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Sa... | Due to convenience kits containing a kit component that is under a recall action for improper use. | Class II | Windstone Medical Packaging, Inc. |
| Aug 16, 2024 | Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health S... | Due to convenience kits containing a kit component that is under a recall action for improper use. | Class II | Windstone Medical Packaging, Inc. |
| Aug 16, 2024 | Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Sal... | Due to convenience kits containing a kit component that is under a recall action for improper use. | Class II | Windstone Medical Packaging, Inc. |
| Aug 15, 2024 | STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood be... | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... | Class II | B Braun Medical Inc |
| Aug 15, 2024 | Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-I... | Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 40... | Class II | Roche Diagnostics Operations, Inc. |
| Aug 15, 2024 | Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system | Due to affected devices that may have bent female IUI connector and may not be operable and poten... | Class II | CareFusion 303, Inc. |
| Aug 15, 2024 | STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood be... | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... | Class II | B Braun Medical Inc |
| Aug 15, 2024 | Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system | Due to affected devices that may have bent female IUI connector and may not be operable and poten... | Class II | CareFusion 303, Inc. |
| Aug 15, 2024 | Alaris Pump Module Model 8100, a modular infusion pump and monitoring system | Due to affected devices that may have bent female IUI connector and may not be operable and poten... | Class II | CareFusion 303, Inc. |
| Aug 15, 2024 | ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the q... | Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeti... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 15, 2024 | ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with... | If ultrasound systems with software, are changed from factory default to : 1) Milliliters per sec... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 15, 2024 | Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quanti... | Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeti... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 15, 2024 | ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ... | If ultrasound systems with software, are changed from factory default to : 1) Milliliters per sec... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 15, 2024 | Alaris PCA Module Model 8120, a modular infusion pump and monitoring system | Due to affected devices that may have bent female IUI connector and may not be operable and poten... | Class II | CareFusion 303, Inc. |
| Aug 15, 2024 | ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 1133579... | If ultrasound systems with software, are changed from factory default to : 1) Milliliters per sec... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 15, 2024 | STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a h... | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... | Class II | B Braun Medical Inc |
| Aug 15, 2024 | STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood betwe... | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... | Class II | B Braun Medical Inc |
| Aug 15, 2024 | STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a... | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... | Class II | B Braun Medical Inc |
| Aug 15, 2024 | STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a... | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... | Class II | B Braun Medical Inc |
| Aug 15, 2024 | SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between ... | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Blood... | Class II | B Braun Medical Inc |
| Aug 15, 2024 | Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system | Due to affected devices that may have bent female IUI connector and may not be operable and poten... | Class II | CareFusion 303, Inc. |
| Aug 14, 2024 | 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R | Contamination with foreign substance matter | Class II | 3M Company - Health Care Business |
| Aug 14, 2024 | TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA P... | Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fus... | Class II | Innovasis, Inc |
| Aug 13, 2024 | Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resect... | The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(... | Class II | Olympus Corporation of the Americas |
| Aug 13, 2024 | Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF,... | This product labeling does not adequately provide warning about the risks associated with the use... | Class II | Zoe Medical Incorporated |
| Aug 13, 2024 | Soltive Premium SuperPulsed Laser - Intended for incision, excision, resectio... | The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(... | Class II | Olympus Corporation of the Americas |
| Aug 13, 2024 | Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT)... | This product labeling does not adequately provide warning about the risks associated with the use... | Class II | Zoe Medical Incorporated |
| Aug 12, 2024 | ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation ... | Product packaging process may result in an improper or incomplete seal of the outer foil pouch su... | Class II | Smith & Nephew Inc. |
| Aug 12, 2024 | Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F) | 7F sheath introducers labeled as 7.5F | Class II | Merit Medical Systems, 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.