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 5, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Discovery NM/CT 670 ES When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been… Class IIFDA’s classDec 19, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 19, 2018ClassClass IIStatusCompletedWhereCalifornia, District of Columbia, Ohio, Utah and Wisconsin
- Medical device recall Discovery NM/CT 670 Pro When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been… Class IIFDA’s classDec 19, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 19, 2018ClassClass IIStatusCompletedWhereCalifornia, District of Columbia, Ohio, Utah and Wisconsin
- Medical device recall GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 12, 2018ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT Potential that gauze pads may not be fully sterilized Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedDec 12, 2018ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Florida, Iowa, Indiana, Kentucky, New York, Oklahoma, Texas, Utah and Virginia named
- Medical device recall NEOCONNECT, Enteral Extension with ENFit connector The sterile pouch label states the expiration date is 2016-11-19, but the correct expiration date is 2019-11-09. Class IIIFDA’s classDec 12, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 12, 2018ClassClass IIIStatusTerminatedWhereCalifornia, Florida, Illinois, Michigan, New Jersey, Ohio, Tennessee and Texas
- Medical device recall Optional MDRC-1119 Front Cover Attachment Kit for review display monitors If metal strips are removed and re-applied to another display, there is potential for the metal strips to be deformed resulting in a smaller contact surface… Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Illinois, Texas and Wisconsin named
- Medical device recall BD BBL Trypticase Soy Agar with 5% Sheep Blood a portion of a single lot was not manufactured in accordance with the internal formulation resulting in inhibited growth of Gram negative organisms. Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Texas, Virginia, Vermont, Washington and West Virginia named
- Medical device recall Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Due to a customer experiencing complaints on bone fraction of assay not being in range. Class IIIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 12, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Georgia, Indiana and Michigan named
- Medical device recall Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm Diameter, 70 cm Length Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 cm Length Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 cm Length Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm Length Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 100 cm Length Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 70 cm Length Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 70 cm Length Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product’s chevron opening compromising product sterility Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance 64 There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance 40 There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance 16 Slice (Power) There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance 16 Slice (Air) There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance 10 Slice (Air) There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance 6 Slice (Air) There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Invacare 9805 and 9805P Hydraulic Patient Lifts Invacare has identified via customer complaints, the potential for the mounting bolt connecting the caster to the base frame of the patient lifts to become… Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Captus 3000 Thyroid Uptake System There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the arm). Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Iowa, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall Captus 700 Thyroid Uptake System There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the arm). Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Iowa, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Indiana and Maryland named
- Medical device recall Thermacare Muscle Pain Therapy HeatWraps: a) The firm received complaints of the wrap coming apart and leaking granular material Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Thermacare HeatWraps Menstrual a) The firm received complaints of the wrap coming apart and leaking granular material Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Thermacare HEATWRAPS JOINT PAIN THERAPY, 8 HEATWRAPS The firm received complaints of the wrap coming apart and leaking granular material Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The… The firm has detected a potential risk using the command. Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Indiana, Missouri, Pennsylvania, Tennessee, Wisconsin and West Virginia named
- Medical device recall Artis Zee and Zeego This recall has been initiated due to a possible leakage of a hose in the cooling unit of the X-ray tube. Class IIFDA’s classDec 12, 2018in FDA’s Enforcement Report12 statesnamed in where it went PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Maryland, Minnesota, New Mexico, Oklahoma, Pennsylvania, Rhode Island, Texas and Utah
- Medical device recall AIA-360 Analyzer The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE This recall has been initiated in response to a seal defect found in certain sterile barrier pouches containing the device. Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES… Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times… Class IIFDA’s classDec 12, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedDec 12, 2018ClassClass IIStatusTerminatedWhereTexas
- Medical device recall QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir) There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 5, 2018ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Florida, Iowa, Louisiana, North Carolina and Texas named
- Medical device recall QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir) There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 5, 2018ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Florida, Iowa, Louisiana, North Carolina and Texas named
- Medical device recall BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter… This recall has been initiated due to a software defect found in the Guide System software when used with NICO BrainPath ports under certain circumstances. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Reprocessed Xcel Bladeless Trocar (H12LP) Through investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall were distributed to facilities within the distribution chain… Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedDec 5, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Georgia, Iowa, Illinois, Louisiana, Maryland, New Jersey, Oklahoma, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the… Siemens Healthcare Diagnostics has confirmed that Dimension Vista Lactate Dehydrogenase (LDI) may exhibit an erroneously elevated result when the preceding… Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is… PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is… PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is… PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2018ClassClass IIStatusTerminatedWhereNationwide
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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