Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 10 Recalled by FDA on Jul 11, 2018 Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 11 M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 12.5 M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 13.5 M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 15 M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 16.25 M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 17.5 M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 20 M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 22.5 M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 7.5 M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 9 M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall REPLANT 5.0mmD ABUTMENT Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant Class IIFDA’s classJul 11, 2018in FDA’s Enforcement Report16 statesnamed in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois, Louisiana, Michigan, Montana, North Carolina, New Jersey, New York, Oklahoma, Oregon, South Carolina, South Dakota, Tennessee and Washington
- Medical device recall Medtronic MiniMed Paradigm Veo Insulin Pump Product The MiniMed Paradigm Veo insulin pump has an error that impacts the Arabic language translation.This translation error occurs in the Predictive Alerts setting… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Brilliance Big Bore Radiology 728244 A problem has been detected in the X-Ray Tube. Class IIFDA’s classJul 4, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereHawaii, Kansas and Missouri
- Medical device recall Philips Ingenuity Core 728321 A problem has been detected in the X-Ray Tube. Class IIFDA’s classJul 4, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereHawaii, Kansas and Missouri
- Medical device recall Ingenuity Core128 728323 A problem has been detected in the X-Ray Tube. Class IIFDA’s classJul 4, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereHawaii, Kansas and Missouri
- Medical device recall Ingenuity TF PET/CT 882442 A problem has been detected in the X-Ray Tube. Class IIFDA’s classJul 4, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereHawaii, Kansas and Missouri
- Medical device recall Ingenuity Core128/Elite China 728324 A problem has been detected in the X-Ray Tube. Class IIFDA’s classJul 4, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereHawaii, Kansas and Missouri
- Medical device recall Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1) The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. Class IIFDA’s classJul 4, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Kansas, Maine, Puerto Rico and West Virginia
- Medical device recall Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2) The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. Class IIFDA’s classJul 4, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Kansas, Maine, Puerto Rico and West Virginia
- Medical device recall Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3) The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. Class IIFDA’s classJul 4, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Kansas, Maine, Puerto Rico and West Virginia
- Medical device recall CS-7, Model No. A4C1 Panasonic has issued a Mandatory Product Safety Notice, indicating a possibility of battery ignition (fire) in CF-C2 “Toughbook” laptops. Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ImagePilot, Model No. D9MA Panasonic has issued a Mandatory Product Safety Notice, indicating a possibility of battery ignition (fire) in CF-C2 “Toughbook” laptops. Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARTIS Pheno Interventional Fluoroscopic X-Ray System If the C-arm is manually moved in the longitudinal direction to a fully extended position, the system’s safety stop mechanism may be activated. Class IIFDA’s classJul 4, 2018in FDA’s Enforcement Report18 statesnamed in where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, New York, Ohio, Tennessee, Texas, Utah and Virginia
- Medical device recall The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam… IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue. Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportFloridathe one state its words name PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter There is a potential for a different set to be mixed within the lot, where the incorrect set does not contain an air eliminating filter. Class IIFDA’s classJul 4, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereCalifornia, Illinois and Texas
- Medical device recall ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma When the ABX Pentra Micro ALBUMIN 2 CP (ALBT2) Reagent 2 is sampled and dispensed immediately after an ABX Pentra Creatinine 120 CP (CREA3) Reagent 2 dispense,… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2” The incorrect plastic was used to manufacture the handles of these shears, which causes the handles to melt if sterilized. Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HLD Systems 600 Series Washer/Pasteurizer, UDI There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn. Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Indiana, North Carolina, Nebraska, Utah and West Virginia named
- Medical device recall Vanguard Complete Knee System Two lots of tibial bearings were commingled. Class IIFDA’s classJul 4, 2018in FDA’s Enforcement Report18 statesnamed in where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Georgia, Iowa, Indiana, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, New Jersey, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia and Wisconsin
- Medical device recall RayStation Radiation Therapy Treatment Planning System The dose calculation accuracy may in some situations be less than expected. Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER Improper installation of hand piece may result in a weakening of the internal hose connection which can cause loss of pressure to the device or a hose burst. Class IIFDA’s classJul 4, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Missouri, Ohio and Texas
- Medical device recall OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028 The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and the table will start to rotate from 0 to + 90 /- 90 degree… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025 The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and the table will start to rotate from 0 to + 90 /- 90 degree… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000 When assembling an HME or Filter on this breathing circuit the tubing may be pushed up and inadvertently cover or block the exhalation port. Class IIFDA’s classJul 4, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereIllinois, New Jersey, Nevada, Texas and Utah
- Medical device recall Artis Q biplane, Material no. 10848282, for angiography and whole body radiographic/fluoroscopic procedures. After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Artis Q ceiling, Material no. 10848281, for angiography and whole body radiographic/fluoroscopic procedures. After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Artis Q.zen biplane, Material no. 10848355, for angiography and whole body radiographic/fluoroscopic… After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Artis Q.zeego, Material no. 10848283, for angiography and whole body radiographic/fluoroscopic procedures. After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Artis Q.zen floor, Material no. 10848353, for angiography and whole body radiographic/fluoroscopic procedures. After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Artis zee biplane, Material no. 10094141, for angiography and whole body radiographic/fluoroscopic procedures. After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Artis zee biplane MN, Material no. 10094143, for angiography and whole body radiographic/fluoroscopic… After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Artis zee ceiling, Material no. 10094137, for angiography and whole body radiographic/fluoroscopic procedures. After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Artis zee floor, Material no. 10094135, for angiography and whole body radiographic/fluoroscopic procedures. After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Artis zee floor MN, Material no. 10094142, for angiography and whole body radiographic/fluoroscopic… After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Artis zee MP, Material no. 10094139, for angiography and whole body radiographic/fluoroscopic procedures. After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures. After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Diagnostic Ultrasound System, Aplio I-series The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the main power switch on the rear of… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Delaware, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nevada, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia and Wyoming named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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