Browse Device Recalls
3,306 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,306 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 3,306 FDA device recalls in IL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Nov 20, 2012 | The Centricity Laboratory System is intended to be an information system desi... | GE Healthcare is aware of a potential safety issue associated with the use of GE Centricity Labor... | Class III | GE Healthcare It |
| Nov 20, 2012 | Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System... | The Centricity Laboratory removes free-text notes on a master panel when the user deletes the sla... | Class II | GE Healthcare It |
| Nov 16, 2012 | Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in elec... | ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh section... | Class II | Arjo, Inc. dba ArjoHuntleigh |
| Nov 16, 2012 | Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB,... | ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh section... | Class II | Arjo, Inc. dba ArjoHuntleigh |
| Nov 16, 2012 | Centricity Enterprise Archive is a software product for receiving, archiving ... | There is a potential for data loss associated with empty path names resulting from HL-7 updates w... | Class II | Ge Healthcare It |
| Nov 15, 2012 | GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Ar... | While merging exams in a test instance, merges carry forward in the production system, when the m... | Class II | GE Healthcare It |
| Nov 14, 2012 | Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Tr... | RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining i... | Class II | Leica Microsystems, Inc. |
| Nov 13, 2012 | Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissu... | The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the ... | Class II | Leica Microsystems, Inc. |
| Nov 8, 2012 | Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescr... | The non-sterile Waste Bag component in the custom pack was attached to the outside of the pack in... | Class II | Medline Industries 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. |
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.