Browse Device Recalls

2,609 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,609 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 2,609 FDA device recalls in 2023.

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DateProductReasonClassFirm
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 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 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 Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-080... An unexpected shutdown of the IABP may occur due to loss of communication between the Executive P... Class I Datascope Corp.
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 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 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 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 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 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 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 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 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 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 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 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 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.
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accesso... MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been inc... Class II Baxter Healthcare Corporation
Feb 1, 2023 In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147 Due to temperature excursions with products (products being stored outside of the required temper... Class II BioFire Diagnostics, LLC
Feb 1, 2023 BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for... Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... Class II Becton Dickinson & Company
Feb 1, 2023 MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhi... Kits with affected microtiter plates have the potential to produce low OD values, causing the run... Class II Quidel Corporation
Feb 1, 2023 BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein... New warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein... Class II Aniara Diagnostica LLC
Feb 1, 2023 BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-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 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
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 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 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 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 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 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

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.