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 |
|---|---|---|---|---|
| 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. |
| Feb 6, 2013 | Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. 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+ Infusion Pump. List Number 11971. The Plum A+ Infusion Systems are a... | 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+ Infusion Pump. List Number 11973. The Plum A+ Infusion Systems are a... | 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+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion S... | 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 12618. 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 5, 2013 | Symbiq One Channel Infuser; an Rx medical device infusion pump used to admini... | Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pu... | Class II | Hospira Inc. |
| Feb 5, 2013 | Symbiq Two Channel Infuser; an Rx medical device infusion pump used to admini... | Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pu... | Class II | Hospira Inc. |
| Feb 4, 2013 | Symbiq One Channel Infuser; an Rx medical device infusion pump used to admini... | Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein O... | Class II | Hospira Inc. |
| Feb 4, 2013 | Symbiq Two Channel Infuser; an Rx medical device infusion pump used to admini... | Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and... | Class II | Hospira Inc. |
| Feb 4, 2013 | Symbiq Two Channel Infuser; an Rx medical device infusion pump used to admini... | Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein O... | Class II | Hospira Inc. |
| Feb 4, 2013 | Symbiq One Channel Infuser; an Rx medical device infusion pump used to admini... | Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and... | Class II | Hospira Inc. |
| Feb 4, 2013 | The Hospira Symbiq Infusion System is intended for the delivery of fluids, so... | The devices secondary audio signal fails to activate. | Class II | Hospira Inc. |
| Feb 1, 2013 | The Plum A+ Infusion Systems are a multipurpose family of devices that provid... | A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... | Class II | ICU |
| Feb 1, 2013 | The Plum A+ Infusion Systems are a multipurpose family of devices that provid... | A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... | Class II | ICU |
| Feb 1, 2013 | The Plum A+ Infusion Systems are a multipurpose family of devices that provid... | A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... | Class II | ICU |
| Feb 1, 2013 | The Plum A+ Infusion Systems are a multipurpose family of devices that provid... | A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... | Class II | ICU |
| Feb 1, 2013 | The Plum A+ Infusion Systems are a multipurpose family of devices that provid... | A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... | Class II | ICU |
| Feb 1, 2013 | The Plum A+ Infusion Systems are a multipurpose family of devices that provid... | A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... | Class II | ICU |
| Feb 1, 2013 | The Plum A+ Infusion Systems are a multipurpose family of devices that provid... | A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... | Class II | ICU |
| Feb 1, 2013 | The Plum A+ Infusion System is a cassette based multifunction infusion system... | Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The dis... | Class II | Hospira Inc. |
| Feb 1, 2013 | The Plum A+ Infusion System is a cassette based multifunction infusion system... | Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The dis... | Class II | Hospira Inc. |
| Feb 1, 2013 | The Plum A+ Infusion System is a cassette based multifunction infusion system... | Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The dis... | Class II | Hospira Inc. |
| Feb 1, 2013 | The Plum A+ Infusion System is a cassette based multifunction infusion system... | Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The dis... | Class II | Hospira Inc. |
| Feb 1, 2013 | The Plum A+3 Infusion System is a cassette based multifunction infusion syste... | Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The dis... | Class II | Hospira Inc. |
| Feb 1, 2013 | The Plum A+ Infusion Systems are a multipurpose family of devices that provid... | A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... | Class II | ICU |
| Feb 1, 2013 | The Plum A+ Infusion Systems are a multipurpose family of devices that provid... | A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... | Class II | ICU |
| Feb 1, 2013 | The Plum A+3 Infusion System is a cassette based multifunction infusion syste... | Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The dis... | Class II | Hospira Inc. |
| Feb 1, 2013 | The Plum A+3 Infusion System is a cassette based multifunction infusion syste... | Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The dis... | Class II | Hospira Inc. |
| Feb 1, 2013 | The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infu... | Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The dis... | Class II | Hospira Inc. |
| Jan 23, 2013 | Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product... | Affected products have a labeled expiration date of one year too long. | Class III | Bion Enterprises Ltd |
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.