Browse Device Recalls

3,367 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,367 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 3,367 FDA device recalls in IL.

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DateProductReasonClassFirm
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
Mar 8, 2013 LifeCare PCA infusion system with Hospira MedNet software allows clinicians t... Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted ... Class II Hospira Inc.
Mar 8, 2013 The LifeCare Pump Model 4200 PCA Infuser makes possible the practical impleme... Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted ... Class II Hospira Inc.
Mar 8, 2013 The PCA 3 system cam be used in a wide range of clinical settings, including ... Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted ... Class II Hospira Inc.
Mar 8, 2013 The LifeCare PCA Plus II infusion pump system is designed for safe, effective... Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted ... Class II Hospira Inc.
Mar 8, 2013 LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Nu... Screw rotation error occurring when the pump detects a mismatch between the number of steps given... Class II Hospira Inc.
Mar 8, 2013 LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administ... Screw rotation error occurring when the pump detects a mismatch between the number of steps given... Class II Hospira Inc.
Feb 27, 2013 The LifeCare PCA infusion system with Hospira MedNet software allows clinicia... The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing.... Class II Hospira Inc.
Feb 27, 2013 The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer ... The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing.... Class II Hospira Inc.
Feb 25, 2013 MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Prod... Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets inclu... Class II Baxter Healthcare Corp.
Feb 25, 2013 CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. ... Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets inclu... Class II Baxter Healthcare Corp.
Feb 25, 2013 MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for ... Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets inclu... Class II Baxter Healthcare Corp.
Feb 25, 2013 MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5... Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets inclu... Class II Baxter Healthcare Corp.
Feb 19, 2013 Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free ... Hospira, Inc. is voluntarily recalling one lot of list 14699-28, Minibore Extension Set, 59 inch ... Class II Hospira Inc.
Feb 18, 2013 Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 1... A software defect was discovered that causes images to be out of context with clinical information. Class II Ge Healthcare It
Feb 18, 2013 Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solut... It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging... Class II Ge Medical Systems Information T
Feb 18, 2013 The Centricity PACS Workstation is intended for use as a primary diagnostic a... Using Merge Exam in single Study Mode may result in Missing Study Record (Cannot Display Exam, Se... Class II GE Healthcare
Feb 6, 2013 Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20679. The P... The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in a... Class II Hospira Inc.
Feb 6, 2013 Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Syste... The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in a... Class II Hospira Inc.
Feb 6, 2013 Plum A+3 Infusion Pump. List Number 12391. The Plum A+ Infusion Systems are ... The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in a... Class II Hospira Inc.
Feb 6, 2013 Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The ... The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in a... Class II 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.