Medical devices, 2016
Shortlist up to four to read them side by side.
3,246 medical device recalls FDA’s Enforcement Report published in 2016, 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 7, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall AnastoCiip Universal Clip Remover US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are… Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AnastoCiip Universal Clip Remover US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are… Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AnastoCiip Universal Clip Remover US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are… Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AnastoCiip Universal Clip Remover US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are… Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Quickie Q7 wheelchair There is an observed failure of the backrest bracket which can fatigue over the life time of the product. Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Molift Air 205, Molift Air 205 Propulsion, Molift Air IRC, Molift Air 205 IRC Propulsion, Molift Air 300,… Potential for the bolt on the suspension coupling on the Molift Air to come loose from the housing. Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained… Product mix-up. Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide, and New Mexico and Ohio named
- Medical device recall MOSAIQ Oncology Information System It is possible that a change to an Order Set will not be saved in the current open Care Plan. Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2016ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Endotine Transbleph 3.5 (CFD-080-0167) MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to minor mislabeling ( the front label is… Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198 Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected. Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Integra External Fixation System Rocker Bottom The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold. Class IIFDA’s classAug 3, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereColorado, District of Columbia, Florida, Indiana, Oklahoma and Virginia
- Medical device recall SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw. Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Syva¿ EMIT¿ 2000 Theophylline Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the… Class IIFDA’s classAug 3, 2016in FDA’s Enforcement Report24 statesnamed in where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Delaware, Florida, Georgia, Iowa, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Virginia and Washington
- Medical device recall ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the… Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the… Class IIFDA’s classAug 3, 2016in FDA’s Enforcement Report24 statesnamed in where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Delaware, Florida, Georgia, Iowa, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Virginia and Washington
- Medical device recall Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image… A software defect was discovered that causes images to be out of context with clinical information. Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AngioDynamics Soft Vu Omni Flush Angiographic Catheter Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 27, 2016in FDA’s Enforcement Report11 statesnamed in where it went PublishedJul 27, 2016ClassClass IStatusTerminatedWhereCalifornia, Connecticut, Massachusetts, Maryland, New York, Pennsylvania, Texas, Utah, Virginia, Vermont and Washington
- Medical device recall Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V… During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement Report11 statesnamed in where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereArizona, California, Delaware, Florida, Georgia, Illinois, Massachusetts, Missouri, North Carolina, New York and Texas
- Medical device recall RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation… An issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement Report11 statesnamed in where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Delaware, Florida, Hawaii, Maine, Missouri, New York, Ohio, Texas and Washington
- Medical device recall HX2” Temperature Management Systems Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement Report51 statesnamed in where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water… Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement Report51 statesnamed in where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Sarns TCM II Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement Report51 statesnamed in where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Preamendments device-Sarns Dual Cooler-Heater Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Inter… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement Report51 statesnamed in where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder… The product lot did not meet sterility requirements based on FDA sampling and analysis. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereCalifornia, New York and Tennessee
- Medical device recall Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical Instrument DePuy Synthes is initiating a voluntary medical device recall due to Blade/Screw Guide Sleeves (Part # 03.037.017) may have been manufactured with a slightly… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall cobas¿ Liat¿ Analyzer Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Washington
- Medical device recall Carestream Touch Prime A software issue related to the generic volume measurement functionality could result in the volume of the subject anatomy being overestimated. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereGeorgia, Iowa and Texas
- Medical device recall Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter The device could be subject to breaches of its sterile packaging. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The pump (with cushioning foam inserts) is WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Illinois, Kansas, Massachusetts, Maryland, Mississippi, New Jersey, Ohio, Pennsylvania, Tennessee, Texas, Utah and Washington named
- Medical device recall The pump (with cushioning foam inserts) is WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Illinois, Kansas, Massachusetts, Maryland, Mississippi, New Jersey, Ohio, Pennsylvania, Tennessee, Texas, Utah and Washington named
- Medical device recall Spike Set, 12” Microbore SPM-12 WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Illinois, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Utah and Washington named
- Medical device recall T030-000 -30” 20 Drop IV Admin Secondary Set WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Illinois, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Utah and Washington named
- Medical device recall T090-000 90” 20 Drop IV Admin Set WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Illinois, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Utah and Washington named
- Medical device recall T090-000V 90” 20 Drop IV Admin Set w/ Needlefree Y-Site WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Illinois, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Utah and Washington named
- Medical device recall T090-000W 90” 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Illinois, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Utah and Washington named
- Medical device recall T090-022V 90” 20 Drop IV Admin Set Needle free Y-Site & 0.22 Fltr WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Illinois, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Utah and Washington named
- Medical device recall T095-022, IV Set with 0.22 Micron Filter WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Illinois, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Utah and Washington named
- Medical device recall T095-120 IV Set with 1.2 Micron Filter WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Illinois, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Utah and Washington named
- Medical device recall T100-000F, 100” IV Set with Free Flow Clip WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Illinois, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Utah and Washington named
- Medical device recall T100-000VF, IV Set with Lower Y Site and Free Flow Clip WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Illinois, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Utah and Washington named
- Medical device recall T100-000WF, IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and Free Flow Clip WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Illinois, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Utah and Washington named
- Medical device recall T100-022F with 0.22 micron filter and FP Clip WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Illinois, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Utah and Washington named
- Medical device recall T100-120F with 1.2 micron filter and FP Clip WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Illinois, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Utah and Washington named
- Medical device recall T105-000WC IV Set w/2 Y-Sites, BC Vlv & Filter Cap WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Illinois, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Utah and Washington named
- Medical device recall T100-022WF, IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & FP Clip WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Illinois, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Utah and Washington named
- Medical device recall Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form… Incorrect top label on an implant package. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNew York, Ohio and Oregon
- Medical device recall 2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in the following… A variation in flute depth on the routers was observed. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ATEC CANISTER Cracks ATEC Canister Lids. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement Report52 statesnamed in where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating… The screw may fracture at the junction of the shaft and the head during implantation. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass 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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