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 10, 2013 | Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml pe... | Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... | Class I | Symbios Medical Products, LLC |
| May 10, 2013 | Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2m... | Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... | Class I | Symbios Medical Products, LLC |
| May 10, 2013 | Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml pe... | Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... | Class I | Symbios Medical Products, LLC |
| May 10, 2013 | Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/si... | Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... | Class I | Symbios Medical Products, LLC |
| May 10, 2013 | Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(15... | Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... | Class I | Symbios Medical Products, LLC |
| May 10, 2013 | Part 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,..... | Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... | Class I | Symbios Medical Products, LLC |
| May 10, 2013 | Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL sid... | Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... | Class I | Symbios Medical Products, LLC |
| May 10, 2013 | Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL sid... | Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... | Class I | Symbios Medical Products, LLC |
| May 10, 2013 | Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOL... | Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... | Class I | Symbios Medical Products, LLC |
| May 10, 2013 | Part 510450 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 10mL/hr )... | Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... | Class I | Symbios Medical Products, LLC |
| May 8, 2013 | GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and... | Verathon GlideScope Reusable GVL and AVL Blades are being recalled due to the potential risk of p... | Class I | Verathon, Inc. |
| Apr 30, 2013 | EZ Breathe Medication Cup. For the delivery of liquid medications for resp... | Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking ... | Class I | Nephron Pharmaceuticals Corp. |
| Apr 30, 2013 | EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medication... | Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking ... | Class I | Nephron Pharmaceuticals Corp. |
| Apr 30, 2013 | AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ ... | Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking ... | Class I | Nephron Pharmaceuticals Corp. |
| Apr 22, 2013 | Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereota... | Software Error: The effect of setup on overall navigation accuracy could potentially intensify sm... | Class I | Brainlab AG |
| Apr 18, 2013 | Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile... | Cook Medical has received a small number of complaints related to the delivery system for the Zil... | Class I | Cook, Inc. |
| Apr 18, 2013 | Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile ... | Cook Medical has received a small number of complaints related to the delivery system for the Zil... | Class I | Cook, Inc. |
| Apr 17, 2013 | Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube use... | The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes. | Class I | Bryan Medical Inc |
| Apr 15, 2013 | FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic ... | AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Gluco... | Class I | Abbott Diabetes Care, Inc. |
| Apr 5, 2013 | Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batterie... | Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instrumen... | Class I | Newport Medical Instruments Inc |
| Apr 1, 2013 | List No. 14203-28; BLOOD SET; 200 Micron Filter, 80 Inch, Non-DEHP; For Blood... | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... | Class I | Hospira Inc. |
| Apr 1, 2013 | List No. 14212-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-... | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... | Class I | Hospira Inc. |
| Apr 1, 2013 | List No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection S... | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... | Class I | Hospira Inc. |
| Apr 1, 2013 | List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Conver... | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... | Class I | Hospira Inc. |
| Apr 1, 2013 | List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE ... | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... | Class I | Hospira Inc. |
| Apr 1, 2013 | List No. 14217-28; Y-TYPE BLOOD SET; 200 Micron Filter, Prepierced Y-Site, No... | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... | Class I | Hospira Inc. |
| Apr 1, 2013 | List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 Inch, Non-DEHP;... | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... | Class I | Hospira Inc. |
| Apr 1, 2013 | List No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 In... | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... | Class I | Hospira Inc. |
| Apr 1, 2013 | List No. 14207-28; BLOOD SET; 200 Micron Filter, 105 Inch, Non-DEHP; For Bloo... | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... | Class I | Hospira Inc. |
| Mar 29, 2013 | Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466... | Correction to provide clarification and additional labeling to minimize likelihood on implanting ... | Class I | Cordis Corporation |
| Mar 26, 2013 | Presource PBDS, Shoulder Procedure, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Shoulder Arthroscopy, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Knee Arthroscopy, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Hand, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood L... | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Gyn Laparoscopy Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Total Hip, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Total Joint, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Major Abdominal, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Total Knee, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Extremity, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Knee Arthroscopy, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Beaufort Memorial Hospital, Anesthesia Circuit, Kit | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, General Laparoscopy, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 18, 2013 | GemStar Pump - Battery Product Usage: The GemStar Pump is a small and ... | Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview th... | Class I | Hospira Inc. |
| Mar 18, 2013 | The GemStar Pump is a small and lightweight, single channel infusion device d... | Pump shutting off during use without warning. | Class I | Hospira Inc. |
| Mar 18, 2013 | The GemStar Pump is a small and lightweight, single channel infusion device d... | Pump shutting off during use without warning. | Class I | Hospira Inc. |
| Mar 18, 2013 | GemStar Pump - Battery Product Usage: The GemStar Pump is a small and li... | Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview th... | Class I | Hospira Inc. |
| Mar 15, 2013 | McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care syst... | There was an occurrence where the patient case data did not match the patient data when the case ... | Class I | MCKESSON TECHNOLOGIES INC. |
| Mar 15, 2013 | The GemStar Pump is a small and lightweight, single channel infusion device d... | The proximal and distal pressure sensor calibration can drift resulting in the pump failing the P... | Class I | Hospira 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.