Browse Device Recalls
3,087 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,087 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 3,087 FDA device recalls in IL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 15, 2013 | pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8... | The data printed on the thermal printer may omit a digit or decimal point in the results or sampl... | Class II | Sysmex America Inc |
| May 15, 2013 | Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Contai... | A firm's internal investigation led to the discovery of pinholes in the packaging of the products... | Class II | Baxter Healthcare Corp. |
| May 10, 2013 | Responder 5 is a nurse call communication system that connects patients with ... | A counterfeited electronic component was identified in the products affected. The component, a da... | Class II | Rauland-Borg Corp |
| Apr 22, 2013 | 1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) ... | CareFusion has received four (4) customer reports of a component (oxygen connector) within the re... | Class II | Carefusion 2200 Inc |
| Apr 19, 2013 | Centricity Enterprise Archive is a software product for receiving, archiving ... | GE Healthcare has become aware of a potential data loss issue associated with empty path names re... | Class II | Ge Healthcare It |
| Apr 16, 2013 | 1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical lase... | A defect in the controller board can lead to the condenser to the video monitor becoming too warm... | Class II | Ziemer Usa Inc |
| Apr 15, 2013 | Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; sing... | Cypress Medical Products LLC is voluntarily recalling one lot of the Owens and Minor (O&M) Umbili... | Class II | Cypress Medical Products LLC |
| Apr 4, 2013 | LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060... | An LPC Fine Mesh Cassette failed to stay closed during processing operations. | Class II | Leica Microsystems, 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. |
| 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. 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. 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. 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. 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. 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. 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. 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. |
| Mar 31, 2013 | The UF-1000i is a fully automated urine particle analyzer intended for vitro ... | The current Century Break patch did not contain the same setting for the Century Break year for b... | Class II | Sysmex America, Inc. |
| Mar 28, 2013 | The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analy... | 20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis CEP 4 (Alpha Satellit... | Class III | Abbott Molecular |
| Mar 28, 2013 | A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol... | Customers have reported that when separating an individual package from its attached grouping, th... | Class II | Baxter Healthcare Corp. |
| Mar 28, 2013 | A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only,... | Customers have reported that when separating an individual package from its attached grouping, th... | Class II | Baxter Healthcare Corp. |
| Mar 28, 2013 | A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0... | Customers have reported that when separating an individual package from its attached grouping, th... | Class II | Baxter Healthcare Corp. |
| Mar 28, 2013 | A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0... | Customers have reported that when separating an individual package from its attached grouping, th... | Class II | Baxter Healthcare Corp. |
| 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 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, 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, 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, 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, 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 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, 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, 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 | 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, 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 | 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, 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, 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 21, 2013 | The GemStar Pump is a small and lightweight, single channel infusion device d... | During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medica... | Class II | Hospira Inc. |
| Mar 21, 2013 | The GemStar Pump is a small and lightweight, single channel infusion device d... | During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medica... | Class II | Hospira Inc. |
| Mar 19, 2013 | GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (p... | Some patients are obtaining access to the dosage reset codes required to change the settings on G... | Class II | Hospira Inc. |
| Mar 19, 2013 | GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (p... | Some patients are obtaining access to the dosage reset codes required to change the settings on G... | Class II | 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 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 ... | 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 | 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. |
| 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. |
| Mar 12, 2013 | The Centricity Laboratory System is intended to be an information system desi... | GE Healthcare has become aware of a potential safety issue associated with the use of GE Centrici... | Class II | GE Healthcare It |
| Mar 12, 2013 | The Centricity Laboratory System is intended to be an information system desi... | GE Healthcare is aware of a potential safety issue with the use of GE Centricity Laboratory Instr... | Class II | GE Healthcare It |
| Mar 11, 2013 | Centricity Perinatal and Centricity Intensive Care is intended to be used in ... | 1) Under rare network conditions, a Centricity Perinatal process may maintain an incorrect count ... | Class II | GE Healthcare It |
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.