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 HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system Upon completion of a 6D workflow, the HexaPOD evo Module may be in a tilted state if it is moved to the position used for 3D (non-iGUIDE) treatments resulting… Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arctic Sun Temperature Management System An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement Report52 statesnamed in where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The… Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall BLAST Bandage, sterile. Blast Bandages (part# BLAST) with Lot# 0617 were not terminally sterilized. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement Report29 statesnamed in where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, New Mexico, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia and Wisconsin
- Medical device recall AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677)… The diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Michigan, New Hampshire, New York, Ohio, Oregon, Pennsylvania, South Carolina, Utah and West Virginia named
- Medical device recall OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset The Internal packaging, the pouch and patient labels are improperly labeled. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Illinois and Massachusetts named
- Medical device recall PR4100 Microplate Reader US The connector of the power supply was capable of fitting other components provided with the system. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement Report11 statesnamed in where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Florida, Georgia, Massachusetts, Maryland, Pennsylvania, Rhode Island, Utah and Washington
- Medical device recall GIBCO CTS AIM V Serum-Free Media (SFM) It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement Report11 statesnamed in where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Florida, Georgia, Massachusetts, Maryland, Pennsylvania, Rhode Island, Utah and Washington
- Medical device recall Gibco Dulbecco’s Modified Eagle Medium (DMEM), high glucose, pyruvate It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement Report11 statesnamed in where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Florida, Georgia, Massachusetts, Maryland, Pennsylvania, Rhode Island, Utah and Washington
- Medical device recall Gibco Dulbecco’s Modified Eagle Medium (DMEM), high glucose It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement Report11 statesnamed in where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Florida, Georgia, Massachusetts, Maryland, Pennsylvania, Rhode Island, Utah and Washington
- Medical device recall Gibco RPMI 1640 Medium It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement Report11 statesnamed in where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Florida, Georgia, Massachusetts, Maryland, Pennsylvania, Rhode Island, Utah and Washington
- Medical device recall Gibco Dulbecco’s Modified Eagle Medium (DMEM), high glucose, pyruvate It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement Report11 statesnamed in where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Florida, Georgia, Massachusetts, Maryland, Pennsylvania, Rhode Island, Utah and Washington
- Medical device recall AperFix Femoral Implant Coring Removal Drill, labeled as the following: a A review of product complaints in 2010 identified a trend for the Coring Removal Drill of premature wear and/or breakage. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO Leaks complaints. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportKansasthe one state its words name PublishedAug 1, 2018ClassClass IIStatusOngoingWhereKansas
- Medical device recall Tubing Pack Convenience Kit Kit was labeled with the incorrect Expiration Date of April 30, 2019. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportFloridathe one state its words name PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in… The main vial label lists the incorrect part number, but the cap label is correct. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement Report16 statesnamed in where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, North Carolina, New Jersey, Nevada, New York, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall RayStation Radiation Therapy Treatment Planning System The firm has learned that some RayStation/RayPlan users have commissioned machines with erroneous Beam profile correction parameters. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers… Possible failure of screws which hold the gas spring fixation bracket in place. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Dakota, Tennessee and Texas named
- Medical device recall BioGlue Spreader Tip, 12mm, Sterile The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8” x 1 1/4”) was incorrectly applied to the Syringe Applicator Tip pouches and… Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall cobas m 511 integrated hematology analyzer Discrepant results have been reported in patients with severe microcytic anemia (e.g.iron deficiency, thalassemia) and the following parameters are affected:… Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MX-10 surveillance laser system Product Usage: The expected usage of the product is to facilitate observation… Product has a nominal ocular hazard distance (NOHD) that is longer than specified and persons could be exposed to light in excess of the exposure limit. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are intended for: Shoulder -… The label on Apollo XT 5.5mm Suture Anchor (part # XTS-5515; lots 2358, 2362, and 2363) indicated that the anchor screw material was titanium, however that… Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and California and Oklahoma named
- Medical device recall Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product… This voluntary recall is being conducted due to the curved tip introducer needle which is included in the kit, to have a potential manufacturing defect. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c)… This voluntary recall is being conducted due to the curved tip introducer needle which is included in the kit, to have a potential manufacturing defect. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall AesDex, LLC Cardica C-Port xA PLUS Anastomosis System Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic… Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic… Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Edwards SAPIEN 3 Transcatheter Heart Valve (THV) SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNew Jersey
- Medical device recall Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205 The diluent may have an incomplete slit on the septum in the cap of the vial. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report54 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971 The diluent may have an incomplete slit on the septum in the cap of the vial. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report54 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586 The diluent may have an incomplete slit on the septum in the cap of the vial. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report54 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC Possible diminished performance prior to its established expiration date. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Illinois, Texas and Washington named
- Medical device recall MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque… The product may be packaged with the incorrect length of feeding tube as labeled. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall Disinfection unit UV Under certain circumstances, the firmware makes it possible for the Disinfection unit UV (432332-9020-000) to activate outside of the Celldiscoverer 7 housing. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended… It was discovered that in certain situations, including partial sessions and when taking adhoc measurements, the patient data was not synchronizing in a timely… Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Idaho, Louisiana and Pennsylvania named
- Medical device recall UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S,… Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device… Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Idaho, Kansas, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Oregon, Pennsylvania, South Dakota, Virginia, Washington and Wisconsin
- Medical device recall ADVANSYS TTC Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device… Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Idaho, Kansas, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Oregon, Pennsylvania, South Dakota, Virginia, Washington and Wisconsin
- Medical device recall ADVANSYS MLP/DLP Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device… Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Idaho, Kansas, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Oregon, Pennsylvania, South Dakota, Virginia, Washington and Wisconsin
- Medical device recall Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765S, 111770S, 111775S, 111780S,… Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device… Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Idaho, Kansas, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Oregon, Pennsylvania, South Dakota, Virginia, Washington and Wisconsin
- Medical device recall TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S,… Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device… Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Idaho, Kansas, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Oregon, Pennsylvania, South Dakota, Virginia, Washington and Wisconsin
- Medical device recall PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031 The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report25 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981 The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report25 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall PROLENE SUTURE 4-36”(90CM) 4-0 BLUE, D5988 The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report25 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall PROLENE SUTURE 4-36” The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report25 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall PROLENE SUTURE 30”(75CM) 4-0 BLUE, D7748 The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report25 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall PROLENE SUTURE 36”(90CM) 4-0 BLUE, D7768 The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report25 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall PROLENE SUTURE BLUE 4X18”5/0 DA RB-2 +PLG, D7879 The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report25 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall PROLENE SUTURE 30”(75CM) 8-0 BLUE, D8292 The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report25 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
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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