Browse Device Recalls
3,629 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,629 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 3,629 FDA device recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 17, 2016 | AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mech... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilat... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuo... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanic... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ven... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventila... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuo... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| Apr 13, 2016 | Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor... | Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used ... | Class I | Medtronic |
| Apr 1, 2016 | Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710... | Potential leakage of conductivity sensors of the Dialog Dialysis machines. | Class I | B Braun Medical Inc |
| Apr 1, 2016 | Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product ... | Potential leakage of conductivity sensors of the Dialog Dialysis machines. | Class I | B Braun Medical Inc |
| Apr 1, 2016 | Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The D... | Potential leakage of conductivity sensors of the Dialog Dialysis machines. | Class I | B Braun Medical Inc |
| Apr 1, 2016 | Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code... | Potential leakage of conductivity sensors of the Dialog Dialysis machines. | Class I | B Braun Medical Inc |
| Apr 1, 2016 | Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The... | Potential leakage of conductivity sensors of the Dialog Dialysis machines. | Class I | B Braun Medical Inc |
| Apr 1, 2016 | Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Seria... | Potential leakage of conductivity sensors of the Dialog Dialysis machines. | Class I | B Braun Medical Inc |
| Mar 25, 2016 | NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO... | Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT proced... | Class I | Monteris Medical Corp |
| Mar 22, 2016 | Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. P... | Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving... | Class I | Boston Scientific Corporation |
| Mar 4, 2016 | Guardian II Hemostasis Valve, models 8210 and 8211. The following models are... | Vascular Solutions became aware of a potential problem with the click version of the Guardian II ... | Class I | Vascular Solutions, Inc. |
| Feb 24, 2016 | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 ca... | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... | Class I | Biomerieux Inc |
| Feb 24, 2016 | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 car... | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... | Class I | Biomerieux Inc |
| Feb 24, 2016 | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 car... | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... | Class I | Biomerieux Inc |
| Feb 24, 2016 | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 car... | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... | Class I | Biomerieux Inc |
| Feb 24, 2016 | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 car... | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... | Class I | Biomerieux Inc |
| Feb 24, 2016 | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 car... | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... | Class I | Biomerieux Inc |
| Feb 24, 2016 | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 car... | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... | Class I | Biomerieux Inc |
| Feb 24, 2016 | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 car... | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... | Class I | Biomerieux Inc |
| Feb 24, 2016 | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 car... | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... | Class I | Biomerieux Inc |
| Feb 23, 2016 | Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Rec... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
| Feb 23, 2016 | Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiv... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
| Feb 23, 2016 | Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), ... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
| Feb 23, 2016 | Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Bl... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
| Feb 23, 2016 | Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT2... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
| Feb 23, 2016 | Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receive... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
| Feb 10, 2016 | Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is uti... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilize... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilize... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilize... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is uti... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aort... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow¿ IAB is uti... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is util... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL14... | Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HS... | Class I | Focus Diagnostics Inc |
| Feb 10, 2016 | Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MO... | Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HS... | Class I | Focus Diagnostics Inc |
| Feb 10, 2016 | FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ I... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 4, 2016 | MitraClip Clip Delivery System, product number MSK0101. The MitraClip System ... | Abbott Vascular has recently received reports of cases on Clip Delivery System devices that conta... | Class I | Abbott Vascular |
| Feb 4, 2016 | Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation. | The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation C... | Class I | Draeger Medical, Inc. |
| Jan 29, 2016 | GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video l... | The firm has become aware of the potential for disruption (flickering) in the video laryngoscopy ... | Class I | Verathon, Inc. |
| Jan 7, 2016 | HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, ... | Heartware Ventricular Assist System Battery Cell experiencing premature depletion. | Class I | Heartware, Inc. |
| Jan 6, 2016 | Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays... | A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse e... | Class I | Cook Inc. |
| Jan 6, 2016 | Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject set... | A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse e... | Class I | Cook Inc. |
| Jan 6, 2016 | Single Lumen Central Venous Catheter Sets and Trays The subject sets and t... | A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse e... | Class I | Cook 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.