Browse Device Recalls
3,010 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,010 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 3,010 FDA device recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 1, 2019 | PowerFlow Implatable Apheresis IV Port with attachable 9.6 F ChronoFl x Open... | Firm has identified that the product may be at risk of incorrectly containing a tunneler with a b... | Class II | Bard Peripheral Vascular Inc |
| Oct 1, 2019 | 1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Sing... | Firm has identified that the product may be at risk of incorrectly containing a tunneler with a b... | Class II | Bard Peripheral Vascular Inc |
| Oct 1, 2019 | BardPort M.R.I. Hard Base Implantable Port with Attachable 9.6 F Open-Ended S... | Firm has identified that the product may be at risk of incorrectly containing a tunneler with a b... | Class II | Bard Peripheral Vascular Inc |
| Sep 30, 2019 | Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RE... | Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. | Class II | Roche Diabetes Care, Inc. |
| Sep 30, 2019 | Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE ME... | Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. | Class II | Roche Diabetes Care, Inc. |
| Sep 30, 2019 | Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SA... | Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. | Class II | Roche Diabetes Care, Inc. |
| Sep 30, 2019 | Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RE... | Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. | Class II | Roche Diabetes Care, Inc. |
| Sep 30, 2019 | Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HC... | Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. | Class II | Roche Diabetes Care, Inc. |
| Sep 30, 2019 | Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SA... | Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. | Class II | Roche Diabetes Care, Inc. |
| Sep 27, 2019 | CARESCAPE Respiratory Module E-sCOVX | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... | Class I | GE Healthcare, LLC |
| Sep 27, 2019 | CARESCAPE Respiratory Module E-sCO | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... | Class I | GE Healthcare, LLC |
| Sep 27, 2019 | CARESCAPE Respiratory Module E-sCAiOE | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... | Class I | GE Healthcare, LLC |
| Sep 27, 2019 | EQ-400-RH-QZ and EQ-400-LH-BK products Product Usage: The device is a ve... | On September 27, 2019 Energetiq Technology (the manufacturer) discovered a problem with their EQ... | Class II | Energetiq Technology Inc |
| Sep 27, 2019 | CARESCAPE Respiratory Module E-sCAiOVE | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... | Class I | GE Healthcare, LLC |
| Sep 27, 2019 | CARESCAPE Respiratory Module E-sCAiO | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... | Class I | GE Healthcare, LLC |
| Sep 27, 2019 | Airway Gas Option N-CAiO | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... | Class I | GE Healthcare, LLC |
| Sep 27, 2019 | CARESCAPE Respiratory Module E-sCAiOV | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... | Class I | GE Healthcare, LLC |
| Sep 26, 2019 | Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer ... | Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectl... | Class II | Life Technologies Holdings Pte Ltd |
| Sep 26, 2019 | Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Cust... | Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectl... | Class II | Life Technologies Holdings Pte Ltd |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System | 660 nm laser diodes may be below rated power output. | Class III | Theralase Inc. |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Use... | Device was shipped without a Unique Device Identification (UDI) label and a separate label identi... | Class III | Theralase Inc. |
| Sep 26, 2019 | Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Cust... | Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectl... | Class II | Life Technologies Holdings Pte Ltd |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System | 905 nm laser diodes may be below rated power output. | Class III | Theralase Inc. |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System | Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-... | Class III | Theralase Inc. |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002 | Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and I... | Class III | Theralase Inc. |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the ... | Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC, 3.75 A, 90 W, 1% peak to peak ripple ... | Class III | Theralase Inc. |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of k... | Device was shipped without a Unique Device Identification (UDI) label. | Class III | Theralase Inc. |
| Sep 26, 2019 | Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM ... | Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectl... | Class II | Life Technologies Holdings Pte Ltd |
| Sep 25, 2019 | AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual ... | Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM. | Class II | Aesculap Implant Systems LLC |
| Sep 25, 2019 | myCordella Patient Kit without ECG, The Cordella System is a comprehensive at... | The firm have received reports of patients myCordella Hubs fully powering themselves down withou... | Class II | ENDOTRONIX |
| Sep 25, 2019 | Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MAN... | The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Crani... | Class II | Brainlab AG |
| Sep 24, 2019 | MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology in... | The user may inadvertently enter Metric values into Height and Weight fields labeled with US Stan... | Class II | Elekta Impac Software |
| Sep 24, 2019 | SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system | SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 24, 2019 | 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001 | Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Si... | Class II | Vygon MFG, Inc., dba/ Churchill Medical Systems... |
| Sep 23, 2019 | Atellica CH 930 Analyzer | Potential for calibration error resulting in QC failures after the calibration run with QC and pa... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 23, 2019 | RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066. | Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and sh... | Class III | Randox Laboratories, Limited |
| Sep 23, 2019 | TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and ... | The firm discovered a software issue associated with the Image-Com module/clinical application pa... | Class II | Tomtec Imaging Systems Gmbh |
| Sep 22, 2019 | Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indica... | The navigated values displayed when using the LPI instrumentation are incorrect due to software i... | Class II | Blue Ortho |
| Sep 19, 2019 | Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660 | Fetal transducers distributed in advance of receiving 510(k) and international clearances. | Class II | Pacific Medical Group Inc. |
| Sep 19, 2019 | Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM... | Fetal transducers distributed in advance of receiving 510(k) and international clearances. | Class II | Pacific Medical Group Inc. |
| Sep 19, 2019 | Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFC... | Fetal transducers distributed in advance of receiving 510(k) and international clearances. Possib... | Class II | Pacific Medical Group Inc. |
| Sep 19, 2019 | Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFP... | Fetal transducers distributed in advance of receiving 510(k) and international clearances. | Class II | Pacific Medical Group Inc. |
| Sep 19, 2019 | Forte Gamma Camera System is intended to produce images depicting the anatomi... | An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... | Class I | Philips Medical Systems (Cleveland) Inc |
| Sep 19, 2019 | MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm | Potentially includes a 3.0mm x 30mm screw instead of 3.0mm x 28mm screw. | Class II | CrossRoads Extremity Systems, LLC |
| Sep 19, 2019 | Forte Gamma Camera System is intended to produce images depicting the anatomi... | An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... | Class I | Philips Medical Systems (Cleveland) Inc |
| Sep 19, 2019 | Forte Gamma Camera System is intended to produce images depicting the anatomi... | An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... | Class I | Philips Medical Systems (Cleveland) Inc |
| Sep 19, 2019 | Forte Gamma Camera System is intended to produce images depicting the anatomi... | An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... | Class I | Philips Medical Systems (Cleveland) Inc |
| Sep 19, 2019 | Forte Gamma Camera System is intended to produce images depicting the anatomi... | An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... | Class I | Philips Medical Systems (Cleveland) Inc |
| Sep 19, 2019 | Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250 | Fetal transducers distributed in advance of receiving 510(k) and international clearances. | Class II | Pacific Medical Group Inc. |
| Sep 19, 2019 | Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-0904... | The firm has become aware there is a potential problem with its DABRA catheters resulting in high... | Class II | Ra Medical Systems, 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.