Browse Device Recalls

111 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 111 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 111 FDA device recalls.

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DateProductReasonClassFirm
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 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 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 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 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+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.
Dec 7, 2012 Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; ... The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break... Class II Hospira Inc.
Dec 7, 2012 Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045;... The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break... Class II Hospira Inc.
Dec 7, 2012 Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest,... The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break... Class II Hospira Inc.
Oct 26, 2012 Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide... The volume control knob on some Plum A+ single channel infusers (located on the back of the infus... Class II Hospira Inc.
Oct 26, 2012 Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Conn... The volume control knob on some Plum A+ single channel infusers (located on the back of the infus... Class II Hospira Inc.
Oct 26, 2012 Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software... The volume control knob on some Plum A+ single channel infusers (located on the back of the infus... Class II Hospira Inc.
Aug 29, 2012 Symbiq Two Channel Infuser; an Rx medical device infusion pump used to admini... The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response,... Class I Hospira Inc.
Aug 29, 2012 Symbiq One Channel Infuser; an Rx medical device infusion pump used to admini... The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response,... 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.