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
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
Jan 23, 2013 Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product... Affected products have a labeled expiration date of one year too long. Class III Bion Enterprises Ltd
Jan 23, 2013 Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Pro... Affected products have a labeled expiration date of one year too long. Class III Bion Enterprises Ltd
Jan 21, 2013 Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and... The upper portion of the hooks on the spreader bar are too flexible for holding the loops of the ... Class II Arjo, Inc. dba ArjoHuntleigh
Dec 18, 2012 Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacit... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capac... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removab... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capaci... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capac... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double ... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removabl... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacit... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capaci... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 14, 2012 Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm... Some of the individual extension set packages were improperly sealed, compromising the sterility ... Class II Baxter Healthcare Corp.
Dec 12, 2012 Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) an... The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely dep... Class II Abbott Laboratories
Dec 10, 2012 Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein th... The Flowtron Trio DVT Pump has been marketed without proper FDA Approval. Class II Arjo, Inc. dba ArjoHuntleigh
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.
Dec 4, 2012 Abbott m2000sp Instrument; an automated fluid handling system for performing ... An issue with the m2000sp Instrument software has been identified whereby, after a series of step... Class II Abbott Molecular
Nov 20, 2012 The Centricity Laboratory System is intended to be an information system desi... If environment variables MICRO_CORRECT_MSG_TYPE and CORRECT_MSG_TYPE are set to different value... 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.