Browse Device Recalls

835 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 835 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 835 FDA device recalls.

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DateProductReasonClassFirm
Aug 6, 2020 The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretiv... COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tes... Class II Life Technologies Corporation
Jul 24, 2020 Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barrica... The catalog ( REF ) number on the peelable inner labels (patient sticker) that is on the inner co... Class II Intrinsic Therapeutics, Inc.
Jul 6, 2020 7" (18 cm) Appx 0.32 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Rem... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/M... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Re... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/R... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Apr 22, 2020 ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Pro... If the C-arm leaves its intended travel path due to a fault within the drivetrain, movements may ... Class II Siemens Medical Solutions USA, Inc
Apr 17, 2020 Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 3, 2020 Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1... When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and... Class II Philips North America, LLC
Mar 13, 2020 Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model ... There were unknown bioburden levels prior to sterilization, which may affect sterility of the pro... Class II Biomet, Inc.
Feb 13, 2020 DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral ... Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's ... Class II Merit Medical Systems, Inc.
Feb 13, 2020 DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Verte... Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's ... Class II Merit Medical Systems, Inc.
Feb 13, 2020 Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination... Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy Class II Siemens Healthcare Diagnostics, Inc.
Feb 13, 2020 ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (... Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy Class II Siemens Healthcare Diagnostics, Inc.
Dec 11, 2019 Centurion- Pathology Container 1150ST STERILE GRADUATED CONTAINER, 32 OZ. 1... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Nov 4, 2019 Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through... Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional co... Class II Medacta Usa Inc
Oct 7, 2019 LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN In... LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. The detent balls ... Class II Smith & Nephew, Inc.
Oct 4, 2019 Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System... The firm became aware of a cleaning solution leaking issue from the middle staining module of the... Class II Ventana Medical Systems Inc
Oct 3, 2019 ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code P... The staplers may contain an out of specification anvil component within the jaw of the device. T... Class I Ethicon Endo-Surgery Inc
Oct 3, 2019 ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code P... The staplers may contain an out of specification anvil component within the jaw of the device. T... Class I Ethicon Endo-Surgery Inc
Oct 3, 2019 ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code P... The staplers may contain an out of specification anvil component within the jaw of the device. T... Class I Ethicon Endo-Surgery Inc
Oct 3, 2019 ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A The staplers may contain an out of specification anvil component within the jaw of the device. T... Class I Ethicon Endo-Surgery Inc
Jul 1, 2019 Universal Sexual Health Testing Kit A supplier informed PrivaPath Diagnostics that there is a potential for damaged tubes which could... Class II Privapath Diagnostics Ltd
May 31, 2019 GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product ... The action is being initiated due to complaints received concerning the molded tip of the tunnel... Class II Bard Peripheral Vascular Inc
May 31, 2019 GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product ... The action is being initiated due to complaints received concerning the molded tip of the tunnel... Class II Bard Peripheral Vascular Inc
May 31, 2019 GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396240, 14.5F, A... The action is being initiated due to complaints received concerning the molded tip of the tunnel... Class II Bard Peripheral Vascular Inc
May 31, 2019 GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product ... The action is being initiated due to complaints received concerning the molded tip of the tunnel... Class II Bard Peripheral Vascular Inc
May 31, 2019 GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product ... The action is being initiated due to complaints received concerning the molded tip of the tunnel... Class II Bard Peripheral Vascular Inc
May 31, 2019 GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396280, 14.5F, A... The action is being initiated due to complaints received concerning the molded tip of the tunnel... Class II Bard Peripheral Vascular Inc
May 31, 2019 GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product ... The action is being initiated due to complaints received concerning the molded tip of the tunnel... Class II Bard Peripheral Vascular Inc
May 31, 2019 GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product ... The action is being initiated due to complaints received concerning the molded tip of the tunnel... Class II Bard Peripheral Vascular Inc
May 31, 2019 GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396190, 14.5F, A... The action is being initiated due to complaints received concerning the molded tip of the tunnel... Class II Bard Peripheral Vascular Inc
May 31, 2019 GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product ... The action is being initiated due to complaints received concerning the molded tip of the tunnel... Class II Bard Peripheral Vascular Inc
May 31, 2019 GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product ... The action is being initiated due to complaints received concerning the molded tip of the tunnel... Class II Bard Peripheral Vascular Inc
May 31, 2019 GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product ... The action is being initiated due to complaints received concerning the molded tip of the tunnel... Class II Bard Peripheral Vascular Inc
May 31, 2019 GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product ... The action is being initiated due to complaints received concerning the molded tip of the tunnel... Class II Bard Peripheral Vascular Inc
Apr 26, 2019 SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR... There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting ... Class I Terumo Medical Corporation
Apr 26, 2019 SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, S... There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting ... Class I Terumo Medical Corporation
Apr 18, 2019 Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material: 709000266 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 4903 Mercy Med w/o Oxy Material:701066664 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BO-TOP 35503 SGD PACK Material: 701067668 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 30907 ECC PUMP PACK Material: 701065770 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BO-TOP 30300 Material:701052623 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge- BEQ-TOP 32100 Adult Custom Pack Material:701054438R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BO-T 44201 MAYO PULMONARY PACK Material: 701064834 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 8025 1/4" ECC Pack with RF32 Material:701055142 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BO-TOP 36504 ADULT ECC PACK Material: 701065765 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-T 8029 PRESSURE PIGTAIL 6" Material: 701055995 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, 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.