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 |
|---|---|---|---|---|
| Mar 29, 2019 | Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purp... | There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall m... | Class II | GE Healthcare, LLC |
| Mar 29, 2019 | Prestilix 1600X Prestilix system is a fully integrated remote controlled... | There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall m... | Class II | GE Healthcare, LLC |
| Mar 29, 2019 | Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone rec... | There may be dimensional manufacturing error that represents a potential safety risk to patients. | Class II | PROVIDENCE MEDICAL TECHNOLOGIES |
| Mar 28, 2019 | T7 Driver Solid AO (Part Number 110018541) Product Usage: The Biomet Head... | There is a potential of fracture, bending or shearing of the driver. | Class II | Zimmer Biomet, Inc. |
| Mar 28, 2019 | IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: ... | The MX40 may experience increased power consumption and may have a lack of visual and/or audible ... | Class II | Philips North America, LLC |
| Mar 28, 2019 | IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: ... | The MX40 may experience increased power consumption and may have a lack of visual and/or audible ... | Class II | Philips North America, LLC |
| Mar 28, 2019 | IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564... | The MX40 may experience increased power consumption and may have a lack of visual and/or audible ... | Class II | Philips North America, LLC |
| Mar 28, 2019 | Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 9531... | Firm received feedback form the market regarding breakage of the plastic joint which connects the... | Class II | R82 A/S |
| Mar 28, 2019 | Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, ... | Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of ballo... | Class I | Edwards Lifesciences, LLC |
| Mar 28, 2019 | T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet... | There is a potential of fracture, bending or shearing of the driver. | Class II | Zimmer Biomet, Inc. |
| Mar 28, 2019 | Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx... | Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of ballo... | Class I | Edwards Lifesciences, LLC |
| Mar 28, 2019 | IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All ... | The MX40 may experience increased power consumption and may have a lack of visual and/or audible ... | Class II | Philips North America, LLC |
| Mar 27, 2019 | ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0 | ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent | Class II | CooperSurgical, Inc. |
| Mar 26, 2019 | EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x1... | Intermittent heat seal failures on the outer pouch of some EZ Derm products. | Class II | Molnlycke Health Care, Inc |
| Mar 25, 2019 | Canon Aquilion One, Model TSX-301A | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u... | Class II | Canon Medical System, USA, INC. |
| Mar 25, 2019 | Canon Aquilion Premium, Model TSX-301B | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u... | Class II | Canon Medical System, USA, INC. |
| Mar 25, 2019 | Horizon Cardiology Hemo | users are not notified of procedure medication discrepancies between the Vitals and Meds, the Pro... | Class II | Change Healthcare Israel Ltd. |
| Mar 25, 2019 | HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTO... | New software version for affected ventilators reduces the probability of the ventilator entering ... | Class I | Hamilton Medical AG |
| Mar 25, 2019 | Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energiza... | Magnet Energization Device (MED) can have a residual voltage on output terminal, may cause electr... | Class II | Philips Medical Systems Nederlands |
| Mar 25, 2019 | Canon Aquilion One Vision, Model TSX-301C | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u... | Class II | Canon Medical System, USA, INC. |
| Mar 25, 2019 | Canon Aquilion Precision, Model TSX-304A | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u... | Class II | Canon Medical System, USA, INC. |
| Mar 25, 2019 | Canon Aquilion Lightning, Model TSX-036A | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u... | Class II | Canon Medical System, USA, INC. |
| Mar 25, 2019 | Canon Aquilion Prime, Model TSX-303A | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u... | Class II | Canon Medical System, USA, INC. |
| Mar 25, 2019 | McKesson Cardiology Hemo | users are not notified of procedure medication discrepancies between the Vitals and Meds, the Pro... | Class II | Change Healthcare Israel Ltd. |
| Mar 25, 2019 | Canon Aquilion Prime SP, Model TSX-303B | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u... | Class II | Canon Medical System, USA, INC. |
| Mar 25, 2019 | Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1 | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u... | Class II | Canon Medical System, USA, INC. |
| Mar 22, 2019 | ChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus ... | Kit label states not made with natural rubber latex,however safety goggles within the kits contai... | Class II | Cardinal Health 200, LLC |
| Mar 22, 2019 | TLS2 Thermal Ligating Shears, Catalog Number 132-131D | The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, th... | Class II | Microline Surgical, Inc. |
| Mar 22, 2019 | Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical ... | The back cover of the light head was insufficiently assembled and could potentially fall off the ... | Class II | Stryker Communications |
| Mar 22, 2019 | ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usa... | Kit label states not made with natural rubber latex,however safety goggles within the kits contai... | Class II | Cardinal Health 200, LLC |
| Mar 22, 2019 | ChemoPlus Chemo Spill Kit, Home Health Kit Product Code:DP5108K Product U... | Kit label states not made with natural rubber latex,however safety goggles within the kits contai... | Class II | Cardinal Health 200, LLC |
| Mar 22, 2019 | Berchtold Chromophare F628 Surgical Lights. Product Usage: The medical ... | The back cover of the light head was insufficiently assembled and could potentially fall off the ... | Class II | Stryker Communications |
| Mar 22, 2019 | Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200... | Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radia... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 22, 2019 | ChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage: ChemoPlus ... | Kit label states not made with natural rubber latex,however safety goggles within the kits contai... | Class II | Cardinal Health 200, LLC |
| Mar 21, 2019 | syngo.via syngo.CT Cardiac Planning, Model Number 10496180 Product Usage: ... | There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning proc... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 21, 2019 | ConMed Anchor Tissue Retrieval System", 12 MM, 300 ML (5/BX) Catalog Number:... | Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... | Class II | Conmed Corporation |
| Mar 21, 2019 | Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal in... | The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout,... | Class II | Flowonix Medical Inc |
| Mar 21, 2019 | syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: ... | There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning proc... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 21, 2019 | Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion. | The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout,... | Class II | Flowonix Medical Inc |
| Mar 21, 2019 | Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, u... | The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout,... | Class II | Flowonix Medical Inc |
| Mar 21, 2019 | Rifton E-Pacer, SKU K660, powered lift device | A design change to the load-bearing quick release buckle renders the springs in the latch mechani... | Class II | Community Products, LLC |
| Mar 21, 2019 | Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No... | The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout,... | Class II | Flowonix Medical Inc |
| Mar 21, 2019 | ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TR... | Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... | Class II | Conmed Corporation |
| Mar 21, 2019 | ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:... | Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... | Class II | Conmed Corporation |
| Mar 21, 2019 | Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion. | The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout,... | Class II | Flowonix Medical Inc |
| Mar 21, 2019 | Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" includin... | Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube... | Class II | ROi Consolidated Service Center (CSC) |
| Mar 21, 2019 | Rifton TRAM Low Base, SKU K320, powered lift device | A design change to the load-bearing quick release buckle renders the springs in the latch mechani... | Class II | Community Products, LLC |
| Mar 21, 2019 | EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usag... | Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress i... | Class I | Edwards Lifesciences, LLC |
| Mar 21, 2019 | Rifton TRAM Standard Base, SKU K310, powered lift device | A design change to the load-bearing quick release buckle renders the springs in the latch mechani... | Class II | Community Products, LLC |
| Mar 21, 2019 | ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog N... | Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... | Class II | Conmed Corporation |
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.