Browse Device Recalls
35,307 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,307 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 35,307 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 8, 2023 | Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S420... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b)... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106;... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 7, 2023 | Cardiosave Rescue. Model Number: 0998-00-0800-83. | Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick ... | Class II | Datascope Corp. |
| 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 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 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 | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080... | There have been reported failures of the high pressure helium regulator, which may cause a helium... | Class II | Datascope Corp. |
| 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 | stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic ex... | Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. S... | Class II | Stryker GmbH |
| 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 | injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in le... | The packaging may be damaged, compromising the sterile barrier. | Class II | Labories Medical Technologies |
| 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 7, 2023 | Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080... | There have been reported failures of the high pressure helium regulator, which may cause a helium... | Class II | Datascope Corp. |
| Feb 7, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, ... | Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick ... | Class II | Datascope Corp. |
| 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 6, 2023 | MYLA comprises AST Filters in conjunction with VITEK MS; middleware which con... | For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workfl... | Class II | Biomerieux Inc |
| Feb 6, 2023 | Phoenix mKDR Xpress, digital mobile diagnostic x-ray system | Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems. | Class II | SEDECAL SA |
| Feb 6, 2023 | Phoenix mKDR, digital mobile diagnostic x-ray system | Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems. | Class II | SEDECAL SA |
| Feb 6, 2023 | Arial mobile application, model #54630 and #54640 for Android devices downloa... | The mobile application for Android devices downloaded from the Google Play Store do not load per ... | Class II | Securitas Healthcare LLC |
| Feb 6, 2023 | G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Nu... | The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 3... | Class II | Biomet, Inc. |
| Feb 3, 2023 | ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the ... | Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the AC... | Class II | Instrumentation Laboratory |
| Feb 3, 2023 | ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostas... | Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the AC... | Class II | Instrumentation Laboratory |
| Feb 3, 2023 | ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis ... | Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the AC... | Class II | Instrumentation Laboratory |
| Feb 3, 2023 | Sit to Stand STS500 Patient Lift | Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be uns... | Class II | Med-Mizer, Inc. |
| 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 | Med-Riser MR600 Patient Lift | Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be uns... | Class II | Med-Mizer, Inc. |
| Feb 3, 2023 | ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in... | Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the AC... | Class II | Instrumentation Laboratory |
| Feb 2, 2023 | ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation de... | Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates wit... | Class II | Wright Medical Technology, Inc. |
| Feb 2, 2023 | BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000; | The field action was initiated in February of 2023 and was limited to the affected lot from sales... | Class II | Miach Orthopaedics |
| Feb 2, 2023 | ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table ... | If, during the procedure, X-ray has been released and a reference image has been stored, the foll... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 2, 2023 | LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Sof... | Under specific circumstances, the U.S. product registration system did not send up enablement req... | Class II | Boston Scientific Corporation |
| Feb 2, 2023 | ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET tab... | In the event of any unintended table movement, the system may not detect the incorrect direction,... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 2, 2023 | Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequen... | Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due t... | Class II | Boston Scientific Corporation |
| Feb 2, 2023 | ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation de... | Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates wit... | Class II | Wright Medical Technology, Inc. |
| Feb 1, 2023 | BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed f... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| Feb 1, 2023 | BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Singl... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| Feb 1, 2023 | BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| Feb 1, 2023 | TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intende... | TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nail... | Class II | Synthes (USA) Products LLC |
| Feb 1, 2023 | Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from ... | Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and fo... | Class II | Stryker Medical Division of Stryker Corporation |
| Feb 1, 2023 | Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P ful... | Automated external defibrillators were potentially distributed with the incorrect language config... | Class II | HeartSine Technologies Ltd |
| Feb 1, 2023 | BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designe... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| Feb 1, 2023 | TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intende... | TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nail... | Class II | Synthes (USA) Products LLC |
| Feb 1, 2023 | Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-... | Microcatheters for embolic coil and diagnostic agent introduction to peripheral/neuro vasculature... | Class II | Scientia Vascular, Inc. |
| Feb 1, 2023 | CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro deter... | The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samp... | Class II | Randox Laboratories |
| Feb 1, 2023 | In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - RE... | Due to temperature excursions with products (products being stored outside of the required temper... | Class II | BioFire Diagnostics, LLC |
| Feb 1, 2023 | BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml, 12.7mm, 28G Sin... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| Feb 1, 2023 | In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116 | Due to temperature excursions with products (products being stored outside of the required temper... | Class II | BioFire Diagnostics, LLC |
| Feb 1, 2023 | TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intende... | TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nail... | Class II | Synthes (USA) Products LLC |
| Feb 1, 2023 | BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two U... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
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.