Browse Device Recalls
2,437 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,437 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 2,437 FDA device recalls in 2013.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 7, 2013 | VITROS 5600 Integrated System, Product Code 6802413. Intended for use in t... | Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS¿ Systems ... | Class II | Ortho-Clinical Diagnostics |
| Feb 7, 2013 | Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medi... | Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility. | Class II | Myco Medical Supplies Inc |
| Feb 7, 2013 | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Co... | Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS¿ Systems ... | Class II | Ortho-Clinical Diagnostics |
| 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 | Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3... | The product has a Lithium Heparin contaminant which could adversely affect coagulation results po... | Class II | Heritage Labs International LLC |
| 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 | Smiths Medical, BCI¿ Remote Alarm Cable (Normally Open & Normally Closed), Re... | In rare instances, the BCI¿ Remote Alarm Cables (BCI¿ Cable) are not transferring alarms when use... | Class I | Smiths Medical ASD, Inc. |
| Feb 6, 2013 | bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. ... | The product package did not contain the correct version of the package insert listing the limitat... | Class II | Biomerieux 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 5, 2013 | SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Dayt... | The recall decision has been made because because it has recently been determined that the instru... | Class II | SpineNet |
| Feb 5, 2013 | Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) an... | Vital Images has found a potential error in measurement generated through the software which aff... | Class II | Vital Images, Inc. |
| Feb 5, 2013 | Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma ... | Potential for the IM rod to break, leaving fragments in the patient. Surgical Techniques guidance... | Class II | DePuy Orthopaedics, Inc. |
| Feb 5, 2013 | REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Ortho... | The Straight Ringloc Button Latch Inserter Handle may have been manufactured at the higher end of... | Class II | Biomet, Inc. |
| Feb 5, 2013 | Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovasc... | Dilatation catheters could exhibit radial versus axial tears should they burst during inflation. | Class II | Cordis Corporation |
| Feb 5, 2013 | ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled el... | Observed instability of the device. | Class II | Zimmer Biomet, 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 | Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanc... | Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsist... | Class II | Genetic Testing Institute,inc |
| Feb 4, 2013 | Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, ... | Incorrect packaging of regular set and fast set cartridges. | Class III | Ultradent Products, 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 4, 2013 | Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavo... | Incorrect packaging of regular set and fast set cartridges. | Class III | Ultradent Products, Inc. |
| Feb 4, 2013 | The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep... | The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath... | Class II | Arrow International Inc |
| Feb 4, 2013 | SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow A... | SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or a... | Class II | SpineNet |
| Feb 4, 2013 | EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessori... | EsophyX2Plus device was not validated under actual or simulated use conditions prior to distribut... | Class II | Endogastric Solutions 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 | Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial R... | There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connect... | Class II | Orthofix, 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 | Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer a... | A dimensional mismatch was identified which can potentially allow for interference between devices. | Class II | Exactech, 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 | Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and can... | The firm has received numerous complaints of the cannulated screw driver tip breaking during surg... | Class II | Integra LifeSciences Corp. |
| 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 |
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.