Medical devices, 2019
Shortlist up to four to read them side by side.
2,801 medical device recalls FDA’s Enforcement Report published in 2019, 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.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular… The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular… The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular… The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular… The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular… The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106 Beckman Coulter has identified a case where a customer using the microltiterplate kit option without a sorting drive encountered a cross-contamination of… Class IIFDA’s classNov 27, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 27, 2019ClassClass IIStatusOngoingWhereNew York and Virginia
- Medical device recall Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end Incorrect packaging; There is a potential that a 1.0 mm carbide blade was packaged in a 0.9 mm carbide blade packaging. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 27, 2019ClassClass IIStatusOngoingWhereFlorida, Iowa, Nevada, Pennsylvania and South Carolina
- Medical device recall MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement Report13 statesnamed in where it went PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereCalifornia, Florida, Iowa, Indiana, Maryland, Michigan, Nevada, New York, Pennsylvania, South Carolina, Tennessee, Texas and Washington
- Medical device recall MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement Report13 statesnamed in where it went PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereCalifornia, Florida, Iowa, Indiana, Maryland, Michigan, Nevada, New York, Pennsylvania, South Carolina, Tennessee, Texas and Washington
- Medical device recall WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 27, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 27, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall HeartStart XL+ Defibrillator/Monitor The rotary therapy selector switch may fail, resulting in unexpected device behavior. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Posiflush Pre-Filled Normal Saline Syringes Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline… Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Posiflush Pre-Filled Normal Saline Syringes Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline… Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOFLO 8F SINGLE PLASTIC FILLED Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock… Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Iowa, Indiana, Kansas, Kentucky, Michigan, Missouri, Mississippi, Montana, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall BIOFLO 8F SINGLE TITANIUM NON- FILLED Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock… Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Iowa, Indiana, Kansas, Kentucky, Michigan, Missouri, Mississippi, Montana, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall BIOFLO 8F SINGLE PLASTIC NON-FILLED Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock… Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Iowa, Indiana, Kansas, Kentucky, Michigan, Missouri, Mississippi, Montana, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall BIOFLO 8F SINGLE PLASTIC FILLED Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock… Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Iowa, Indiana, Kansas, Kentucky, Michigan, Missouri, Mississippi, Montana, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400 Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock… Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Iowa, Indiana, Kansas, Kentucky, Michigan, Missouri, Mississippi, Montana, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Pneumothorax Tray Lidstock perforation line may be over the sterile area of the tray, when it should be on the lip of the tray, potentially compromising the sterility of the… Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Indiana, Michigan, Montana, North Carolina, New York and Ohio named
- Medical device recall The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant… Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereArkansas, California, Michigan, Mississippi, Oklahoma and Texas
- Medical device recall Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm Unintentional shifting of the tip insulation of the firm’s electrosurgical probes. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and… Unintentional shifting of the tip insulation of the firm’s electrosurgical probes. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized… The Fiducial Array may mismatch their measurement files resulting in failed landmark check. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, New York and Oklahoma named
- Medical device recall Energy FX: a) original Aluminum FDA determined that marketing claims surrounding product rendered product a medical device which was adulterated and misbranded. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusCompletedWherePuerto Rico and US Virgin Islands
- Medical device recall MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with… Modified outside of approved manufacturing process Class IIFDA’s classNov 20, 2019in FDA’s Enforcement ReportArkansasthe one state its words name PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArkansas
- Medical device recall Universal Sexual Health Testing Kit A supplier informed PrivaPath Diagnostics that there is a potential for damaged tubes which could result in blood exposure or erroneous results due to an… Class IIFDA’s classNov 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LAG SCREW 3.2MM GUIDE PIN SLEEVE LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ProtectIV¿ Plus Safety IV Catheter, sterile Certain lots of the Model 306701 ProtectIV¿ Plus Safety IV Catheter may exhibit damage on the safety mechanism guard. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report21 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereAlaska, Arizona, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maryland, Minnesota, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington
- Medical device recall 2000 Vascular with 30 Degree option Potential for bed to drop suddenly at the head while a patient is laying on it. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Virginia, Wisconsin and Wyoming named
- Medical device recall EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5) Product was distributed prior to approval or clearance from FDA. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Indiana and South Carolina
- Medical device recall TriMed Countersink 1.7mm, HCS The epoxy on Apex manufactured epoxy-coated instruments can pop off. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TriMed Locking Drill Guide, 2.3mm The epoxy on Apex manufactured epoxy-coated instruments can pop off. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TriMed Hex Driver 1.2, 55mm AO Cannulated The epoxy on Apex manufactured epoxy-coated instruments can pop off. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TriMed Peg Guide Extender The spring on the PEG-Extender can rust due to the type of steel used to manufacture it. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TriMed Wrist Hook Dorsal Impactor The WHD/WHV impactors can rust over time due to an improper manufacturing process. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization… Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Connecticut, Florida, Illinois, Oregon, Pennsylvania and Texas named
- Medical device recall 2.4mm x 2.5 Fluted Pin Pouch Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereNationwide, and Georgia, New York, Ohio and Virginia named
- Medical device recall TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002… The action is being initiated due to potential installation of faulty peltier-elements within the thermo-regulation system. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereNationwide, and Utah named
- Medical device recall Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report17 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Florida, Idaho, Illinois, Kansas, Minnesota, North Carolina, Nevada, New York, Ohio, Texas, Utah and Virginia
- Medical device recall Implant Direct A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereIndiana, Maryland, Texas, Virginia and Washington
- Medical device recall Cadence Science Pressure Control Glass Syringe The glass syringe used with Pressure Control Syringes may potentially break during use. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Florida, Georgia, Iowa, Idaho, Illinois, Missouri, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia and Wisconsin named
- Medical device recall TriMed Olecranon Hook Plate, Lt, 6-Holes The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification… Class IIFDA’s classNov 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereNationwide, and Maryland and Utah named
- Medical device recall RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be used in any further testing. Class IIIFDA’s classNov 20, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 20, 2019ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Lemon Prep: MD0019T - 4 oz tubes MD0019--SUP - Single Use Cups Skin preparation used to enhance signal… Product has the potential to be contaminated with Burholderia cepacia. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used to enhance signal… Product has the potential to be contaminated with Burholderia cepacia. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The… The connector piece to the PEG tube does not pass over the guidewire. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereConnecticut, Indiana, Maryland, New Jersey, Pennsylvania and Virginia
- Medical device recall CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 2… The connector piece to the PEG tube does not pass over the guidewire. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereConnecticut, Indiana, Maryland, New Jersey, Pennsylvania and 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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