Browse Device Recalls
3,461 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,461 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 3,461 FDA device recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 17, 2019 | Medtronic implantable pulse generator: Versa, Dual chamber rate responsive p... | A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jan 17, 2019 | Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD):... | A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jan 17, 2019 | Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber ... | A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jan 3, 2019 | icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed Sy... | There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate | Class I | ICU Medical, Inc. |
| Dec 26, 2018 | Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only | Adverse events have been reported with the use of oxytocin in conjunction with the product in pre... | Class I | WEST PHARMA. SERVICES IL, LTD |
| Dec 26, 2018 | Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only | Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag ... | Class I | WEST PHARMA. SERVICES IL, LTD |
| Dec 26, 2018 | Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only | Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag ... | Class I | WEST PHARMA. SERVICES IL, LTD |
| Dec 21, 2018 | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of... | These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If ... | Class I | Edwards Lifesciences, LLC |
| Dec 21, 2018 | ID Circuit Basic 180, Catalog Number MP01350 Breathing Circuits/Anesthesi... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | VentStar Watertrap (P) 180, Catalog Number MP00361 Breathing Circuits/Ane... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia S... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product ... | These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If ... | Class I | Edwards Lifesciences, LLC |
| Dec 21, 2018 | ID Circuit Watertrap (P) 180, Catalog Number MP01341 Breathing Circuits/... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | VentStar Basic (P) 250, Catalog Number MP00352 Breathing Circuits/Anesthe... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product... | These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If ... | Class I | Edwards Lifesciences, LLC |
| Dec 21, 2018 | VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia ... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | VentStar Basic (P) 180, Catalog Number MP00351 Breathing Circuits/Anesthe... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | ID Circuit Basic 250, Catalog Number MP01348 Breathing Circuits/Anesthesi... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Produc... | These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If ... | Class I | Edwards Lifesciences, LLC |
| Dec 21, 2018 | VentStar Anesthesia WT(P) 180, Catalog Number MP00374 Breathing Circuits/... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 20, 2018 | CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The C... | Potential for abnormally high INR test results with the CoaguChek XS PT Test Strips for customer... | Class I | TERRIFIC CARE LLC |
| Nov 13, 2018 | Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVisi... | During a post approval study the firm found there was an increased risk of corneal haze following... | Class I | RVO 2.0, INC |
| Oct 25, 2018 | QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10... | There is a potential for blood leakage at the blood inlet connector when using the reducing screw... | Class I | Maquet Cardiovascular Us Sales, Llc |
| Oct 25, 2018 | QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000... | There is a potential for blood leakage at the blood inlet connector when using the reducing screw... | Class I | Maquet Cardiovascular Us Sales, Llc |
| Oct 9, 2018 | BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2... | This recall has been initiated due to a software defect found in the Guide System software when u... | Class I | Synaptive Medical Inc |
| Oct 5, 2018 | GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066... | The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. ... | Class I | GE Healthcare, LLC |
| Sep 26, 2018 | StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cra... | An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View usin... | Class I | Medtronic Navigation, Inc. |
| Sep 26, 2018 | TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straig... | During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connecto... | Class I | Oscor, Inc. |
| Sep 20, 2018 | Cardiosave Hybrid IABP, Part Number 0998-00-0800-53 | There is a potential for interruption and/or inability to start therapy to the patient prior to o... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Sep 20, 2018 | Cardiosave Rescue IABP, Part Number 0998-UC-0800-83 | There is a potential for interruption and/or inability to start therapy to the patient prior to o... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Sep 18, 2018 | Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatri... | Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) fu... | Class I | COVIDIEN LLC |
| Sep 14, 2018 | GE Healthcare Millennium MC | A detector can detach and fall. | Class I | GE Healthcare, LLC |
| Sep 14, 2018 | GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Ca... | A detector can detach and fall. | Class I | GE Healthcare, LLC |
| Sep 14, 2018 | GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH A... | A detector can detach and fall. | Class I | GE Healthcare, LLC |
| Sep 13, 2018 | CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips... | Abnormally high INR test results with the affected CoaguChek test strips | Class I | Roche Diagnostics Corporation |
| Sep 4, 2018 | Neuro Omega System, incorporating HaGuide software. For neurological and n... | If cables are improperly connected, current may reach high charge density, causing tissue harm. | Class I | Alpha Omega Engineering |
| Aug 28, 2018 | CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF C... | Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micr... | Class I | Alcon Research, LTD. |
| Aug 28, 2018 | CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT,... | Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micr... | Class I | Alcon Research, LTD. |
| Aug 28, 2018 | CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065... | Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micr... | Class I | Alcon Research, LTD. |
| Aug 28, 2018 | CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT,... | Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micr... | Class I | Alcon Research, LTD. |
| Aug 7, 2018 | Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503U... | There is a potential security vulnerability related to the use of the remote controller accessori... | Class I | Medtronic Inc. |
| Aug 7, 2018 | Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE,... | There is a potential security vulnerability related to the use of the remote controller accessori... | Class I | Medtronic Inc. |
| Aug 2, 2018 | INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 80... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, ... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohis... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 7... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-0... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, M... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohi... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistoche... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana 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.