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 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 | VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Coll... | The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) duri... | Class II | Greiner Bio-One North America, 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 31, 2013 | Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Pr... | During the course of product monitoring, Siemens became aware of a tolerance problem in the power... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 31, 2013 | Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. ... | Hitachi discovered a software error that can occur when simultaneously scanning a patient while p... | Class II | Hitachi Medical Systems America Inc |
| Jan 31, 2013 | Medtronic O-arm Imaging System Product Usage: image-intensified fluorosco... | Potential failure of the braking system that controls the O-arm Imaging System gantry movement in... | Class II | Medtronic Navigation, Inc. |
| Jan 31, 2013 | Century Console Base, Model #043625051b. Intended for use as a platform ... | Concerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not co... | Class II | Salyer Prn Biomedical |
| Jan 30, 2013 | Pressure Monitoring sets with VAMP Plus closed blood sampling system model # ... | The device is being recalled because the firm has received multiple complaints related to incorr... | Class II | Edwards Lifesciences, LLC |
| Jan 30, 2013 | QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: ... | CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials. | Class II | QIAGEN Gaithersburg, Inc. |
| Jan 30, 2013 | QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: ... | CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials. | Class II | QIAGEN Gaithersburg, Inc. |
| Jan 29, 2013 | Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide... | Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross m... | Class II | Vascular Solutions, Inc. |
| Jan 28, 2013 | Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. ... | Isoline defibrillation leads distributed may have internal insulation breach. | Class II | Sorin Group USA, Inc. |
| Jan 28, 2013 | Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48.... | The calculation of dose dynamic plans containing different energy fields is incorrect when the Pe... | Class II | Varian Medical Systems, Inc. Oncology Systems |
| Jan 28, 2013 | Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATES... | Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a ... | Class II | Diagnostica Stago, Inc. |
| Jan 28, 2013 | Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hub... | A portion of a silicone wound drain was found to be cracked. | Class II | Bacterin International, Inc. |
| Jan 28, 2013 | ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, D... | Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where ... | Class II | ConMed Corporation |
| Jan 28, 2013 | ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX... | Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where ... | Class II | ConMed Corporation |
| Jan 28, 2013 | Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The He... | Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use | Class II | Philips Healthcare Inc. |
| Jan 27, 2013 | Prism Medical C-Series Carry Bar, Class I, model number 360755. The inten... | The firm replaced the recalled carry bar with a plastic insert with a carry bar with a metal inse... | Class II | Prism Medical Services USA |
| Jan 25, 2013 | Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066... | Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor),... | Class II | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Jan 25, 2013 | Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operato... | Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor),... | Class II | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Jan 25, 2013 | KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes... | This product is not cleared for marketing in the US. | Class II | Mc-NEIL-PPC, Inc. |
| Jan 25, 2013 | KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged ... | This product is not cleared for marketing in the US. | Class II | Mc-NEIL-PPC, Inc. |
| Jan 25, 2013 | KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz t... | This product is not cleared for marketing in the US. | Class II | Mc-NEIL-PPC, Inc. |
| Jan 25, 2013 | Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with... | Edwards Lifesciences is recalling certain Proplege Coronary Sinus Catheter, model PR9 due to conf... | Class II | Edwards Lifesciences, LLC |
| Jan 24, 2013 | HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Wa... | The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperatur... | Class II | Cenorin, LLC |
| Jan 24, 2013 | User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and... | Change to User Manual to remove one indication for use and amend warnings to emphasize restrictio... | Class II | Intuitive Surgical, Inc. |
| Jan 24, 2013 | Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and ... | The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" ... | Class II | Stryker Howmedica Osteonics Corp. |
| Jan 24, 2013 | Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC345... | Firm was made aware of incidents relating to the difficulty of properly engaging and securing the... | Class II | Stelkast Co |
| Jan 24, 2013 | D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Sy... | The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207,... | Class III | Linvatec Corp. dba ConMed Linvatec |
| Jan 24, 2013 | D3000I Advantage Drive System, 230v, surgical instrument motor. Product Us... | The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207,... | Class III | Linvatec Corp. dba ConMed Linvatec |
| 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 | BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), Ultr... | Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip... | Class II | Bard Peripheral Vascular Inc |
| Jan 23, 2013 | USHER¿ Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A;... | Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip... | Class II | Bard Peripheral Vascular Inc |
| Jan 23, 2013 | MICROSHEATH¿ - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide;... | Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip... | Class II | Bard Peripheral Vascular Inc |
| 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 23, 2013 | BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), Ultr... | Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip... | Class II | Bard Peripheral Vascular Inc |
| Jan 21, 2013 | Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needl... | The label on the device states that the item number is CLGY-2210 when the item number on the devi... | Class II | Churchill Medical Systems, Inc. |
| Jan 21, 2013 | Artis zee systems x-ray, angiographic system | The firm became aware of a potential issue with Artis zee systems bearing model numbers 10094135,... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 21, 2013 | Ingenuity TF PET/CT. Diagnostic imaging system | The system may not default to the same gating trigger with which the data were acquired. This cou... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 21, 2013 | Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 45821... | Alere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test because some of the... | Class III | Alere San Diego, Inc. |
| 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 |
| Jan 21, 2013 | GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Inn... | A locking nut might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, I... | Class II | GE Healthcare, LLC |
| Jan 18, 2013 | St. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery Sy... | The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when... | Class I | St Jude Medical Inc |
| Jan 18, 2013 | Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, S... | The wheelchairs may not meet the specifications of WC-19 (crash testing), therefore the WC-19 ver... | Class II | CHENICA INC. |
| Jan 18, 2013 | ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 ... | On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges. | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 18, 2013 | Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical... | The bipolar energy did not stop after release of the foot pedal. | Class II | Aesculap, 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.