Browse Device Recalls
3,528 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,528 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 3,528 FDA device recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Aug 2, 2018 | NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 76... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antib... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-09... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 7... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immun... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 ... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody,... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 ... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 ... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 ... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Jul 31, 2018 | ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile E... | Endologix is notifying physicians of patient tailored surveillance recommendations as well as gen... | Class I | Endologix |
| Jul 31, 2018 | ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile E... | Endologix is notifying physicians of patient tailored surveillance recommendations as well as gen... | Class I | Endologix |
| Jul 31, 2018 | ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Ster... | Endologix is notifying physicians of patient tailored surveillance recommendations as well as gen... | Class I | Endologix |
| Jul 31, 2018 | ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AF... | Endologix is notifying physicians of patient tailored surveillance recommendations as well as gen... | Class I | Endologix |
| Jul 30, 2018 | UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, ... | Complaints received of sporadic erroneously elevated platelet results without flags or system mes... | Class I | Beckman Coulter Inc. |
| Jul 30, 2018 | UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Produc... | Complaints received of sporadic erroneously elevated platelet results without flags or system mes... | Class I | Beckman Coulter Inc. |
| Jul 30, 2018 | UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product... | Complaints received of sporadic erroneously elevated platelet results without flags or system mes... | Class I | Beckman Coulter Inc. |
| Jul 11, 2018 | Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Un... | Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while... | Class I | Spacelabs Healthcare, Ltd. |
| Jul 5, 2018 | DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system ... | The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional ... | Class I | Pro-Med Instruments Gmbh |
| Jul 5, 2018 | DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percuta... | The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional ... | Class I | Pro-Med Instruments Gmbh |
| Jul 5, 2018 | DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest ... | The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional ... | Class I | Pro-Med Instruments Gmbh |
| Jun 20, 2018 | The Tri-Flo Subglottic Suction System | Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Sub... | Class I | Vyaire Medical |
| Jun 18, 2018 | CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L ... | A May 2015 design change in the cushion seal replacement part and accompanying elbow replacement ... | Class I | Compass Health Brands (Corporate Office) |
| Jun 12, 2018 | Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators... | In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for th... | Class I | Philips Respironics, Inc. |
| May 18, 2018 | EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ... | There is a potential for a disruption in one or more of the triple layer membranes of the ventric... | Class I | BERLIN HEART GMBH |
| May 18, 2018 | AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and... | Potential for control line not appearing on the test strip | Class I | Qiagen Sciences, Inc. |
| May 15, 2018 | Draeger Jaundice Meter JM-103 The device is intended for use in hospitals... | Users have misinterpreted the display for out of range measurement indicated by the blinking" ... | Class I | Draeger Medical Systems, Inc. |
| May 15, 2018 | Draeger Jaundice Meter JM-105 The device is intended for use in hospitals,... | Users have misinterpreted the display for out of range measurement indicated by the blinking "-... | Class I | Draeger Medical Systems, Inc. |
| May 8, 2018 | AirLife Resuscitation Device, Adult labeled as the following: a. Adult, ... | An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct... | Class I | Vyaire Medical |
| May 8, 2018 | AirLife Resuscitation Device, Pediatric labeled as the following: a. Ped... | An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct... | Class I | Vyaire Medical |
| May 7, 2018 | WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numb... | When attempting to recapture the 32-mm device, the tip of the delivery sheath may fold or buckle,... | Class I | Biosense Webster, 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.