Medical devices, 2017
Shortlist up to four to read them side by side.
2,615 medical device recalls FDA’s Enforcement Report published in 2017, 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.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total… Decrease reactivity of R 1 component. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois, Michigan, New York, Oklahoma, Oregon, Puerto Rico, Texas and Virginia
- Medical device recall Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets Product size listed on the labeling is incorrect. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJun 21, 2017ClassClass IIStatusOngoingWhereNationwide, and Connecticut, Florida, Idaho, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Dakota, Texas, Utah and Washington named
- Medical device recall Monica Novii Wireless Patch System product Usage: Novii Interface - The Novii Interface is an accessory to… Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CADD¿ High Volume Administration Set with FlowStop, 21-7381-24 One lot of CADD¿ High Volume Administration sets, part number 21-7381-24, lot number 26X035, incorrectly contained the IFU insert for part number 21-7357-24. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Maryland, Minnesota, Nevada, New York, Ohio, Pennsylvania, Tennessee, Virginia and Vermont named
- Medical device recall Merge PACS software Merge PACS did not show unviewed images when the last view was skipped. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Merge PACS software When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test… Class IIFDA’s classJun 21, 2017in FDA’s Enforcement Report49 statesnamed in where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H,… Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test… Class IIFDA’s classJun 21, 2017in FDA’s Enforcement Report49 statesnamed in where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM… Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test… Class IIFDA’s classJun 21, 2017in FDA’s Enforcement Report49 statesnamed in where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall FEM IM NAIL 15MMDX30CM, FEM IM NAIL 16MMDX30CM FEM IM NAIL 14MMDX32CM FEM IM NAIL 15MMDX32CM FEM IM NAIL… Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test… Class IIFDA’s classJun 21, 2017in FDA’s Enforcement Report49 statesnamed in where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMDX30CM TIBIAL I/M NAIL 14MMDX32CM… Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test… Class IIFDA’s classJun 21, 2017in FDA’s Enforcement Report49 statesnamed in where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL 13MMDX32CM LEFT FEM IM NAIL 14MMDX32CM… Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test… Class IIFDA’s classJun 21, 2017in FDA’s Enforcement Report49 statesnamed in where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z… Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test… Class IIFDA’s classJun 21, 2017in FDA’s Enforcement Report49 statesnamed in where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall 4.5 BROAD SCP PLT 26-H STER Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test… Class IIFDA’s classJun 21, 2017in FDA’s Enforcement Report49 statesnamed in where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for… It was discovered the unit produced a laser emission without pressing the fire button when the slit-lamp was driven to its lowest position prior to use on any… Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Large Stealth Chamber When the Stealth Chamber is used as a reference detector in relative dosimetry, deviation in the measured PDDs at shallow depths and geometric shadowing of… Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms… Storage temperature listed on the label was incorrect. Class IIIFDA’s classJun 14, 2017in FDA’s Enforcement ReportArizonathe one state its words name PublishedJun 14, 2017ClassClass IIIStatusTerminatedWhereArizona
- Medical device recall Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the… a gap between the conveyor belt and the rack tray table (plastic part) may cause vibration of the 5 position racks during the transport. Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportWashingtonthe one state its words name PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereWashington
- Medical device recall Magellan Diagnostics LeadCare and LeadCare II test Kits Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2017ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2017ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software… Zimmer CAS voluntarily conducted a retrospective recall of the Sesamoid Plasty due to the risk of the top of the workstation to potentially fall over during… Class IIFDA’s classJun 14, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereCalifornia and Florida
- Medical device recall Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. Class IIFDA’s classJun 14, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island and Virginia
- Medical device recall Rebreathing Mask, Reservoir bag, with Tubing Recalled by FDA on Jun 14, 2017 Class IIFDA’s classJun 14, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island and Virginia
- Medical device recall Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing Recalled by FDA on Jun 14, 2017 Class IIFDA’s classJun 14, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island and Virginia
- Medical device recall Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m Recalled by FDA on Jun 14, 2017 Class IIFDA’s classJun 14, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island and Virginia
- Medical device recall Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, Two Side… Recalled by FDA on Jun 14, 2017 Class IIFDA’s classJun 14, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island and Virginia
- Medical device recall Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m Recalled by FDA on Jun 14, 2017 Class IIFDA’s classJun 14, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island and Virginia
- Medical device recall Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing Recalled by FDA on Jun 14, 2017 Class IIFDA’s classJun 14, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island and Virginia
- Medical device recall Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn. Recalled by FDA on Jun 14, 2017 Class IIFDA’s classJun 14, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island and Virginia
- Medical device recall Rebreather Oxygen Mask, Adult 7 Recalled by FDA on Jun 14, 2017 Class IIFDA’s classJun 14, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island and Virginia
- Medical device recall Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side… Recalled by FDA on Jun 14, 2017 Class IIFDA’s classJun 14, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island and Virginia
- Medical device recall Non-Rebreather, Oxygen Mask, Adult 7 Recalled by FDA on Jun 14, 2017 Class IIFDA’s classJun 14, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island and Virginia
- Medical device recall Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. Recalled by FDA on Jun 14, 2017 Class IIFDA’s classJun 14, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island and Virginia
- Medical device recall Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. Recalled by FDA on Jun 14, 2017 Class IIFDA’s classJun 14, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island and Virginia
- Medical device recall Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side Valves, with Tubing Recalled by FDA on Jun 14, 2017 Class IIFDA’s classJun 14, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island and Virginia
- Medical device recall Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. Recalled by FDA on Jun 14, 2017 Class IIFDA’s classJun 14, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island and Virginia
- Medical device recall Non-Rebreather Oxygen Mask, Pediatric with Tubing Recalled by FDA on Jun 14, 2017 Class IIFDA’s classJun 14, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island and Virginia
- Medical device recall Non-Rebreather Mask w 7 Recalled by FDA on Jun 14, 2017 Class IIFDA’s classJun 14, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island and Virginia
- Medical device recall Pediatric, High Conc Recalled by FDA on Jun 14, 2017 Class IIFDA’s classJun 14, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island and Virginia
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit Connection issues between the PD transfer set catheter connector and an adapter may lead to leaks and contamination of the fluid pathway which may result in… Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall KYPHON(R) Directional Bone Filler Device, Size: 3 The directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end of the instrument. Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local… The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the snap ring to be seated correctly. Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Arsenal Spinal Fixation System, Set Screw Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body. Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Iowa, Kentucky, Michigan, Minnesota, Nevada, Ohio, Oklahoma, Puerto Rico, South Dakota, Texas, Utah and Virginia named
- Medical device recall SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to exhibit intermittent operation of the nurse call feature. Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device. Class IIFDA’s classJun 14, 2017in FDA’s Enforcement Report20 statesnamed in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Illinois, Indiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, Texas, Virginia, Wisconsin and West Virginia
- Medical device recall Clear Flashback Needle 7cm x 18G AMC/4 Argon Medical has received a complaint from one of their distributors of a potential packaging defect. Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve,… Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with… Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with… Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2017ClassClass 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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