Browse Device Recalls
791 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 791 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 791 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 31, 2020 | 42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79... | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... | Class II | ICU Medical, Inc. |
| Aug 31, 2020 | 26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z... | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... | Class II | ICU Medical, Inc. |
| Aug 31, 2020 | 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chambe... | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... | Class II | ICU Medical, Inc. |
| Aug 24, 2020 | Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expirat... | Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping le... | Class II | Boston Scientific Corporation |
| Aug 13, 2020 | Critical Care Decontamination System (CCDS) Compatible N95 respirators - Pr... | Masks processed at one site were not maintained at levels of condensation during a portion of the... | Class II | Battelle Memorial Institute |
| 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 |
| 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 |
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.