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 5, 2026.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with… It was discovered during a procedure that when the operator made an exposure on the wireless x-ray detector and the image data was sent to the digital… Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883 The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Kansas, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk Presence of loose polypropylene foreign matter above release specification. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Kansas, Michigan, North Carolina, New York, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall Herga foot switch Complaints were received reporting the system would freeze/shut down while in Fulgurate mode. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30 Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision… Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation… Some anomalies have been identified during manufacturing controls. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Illinois, Indiana, Massachusetts, North Carolina and Texas named
- Medical device recall Cell Marque, Podoplanin (D2-40 Mab), 7 mL A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, North Carolina, New Hampshire, Nevada, New York, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Cell Marque, Glypican-3 A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, North Carolina, New Hampshire, Nevada, New York, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, North Carolina, New Hampshire, Nevada, New York, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Cell Marque, MSH6 A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, North Carolina, New Hampshire, Nevada, New York, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, North Carolina, New Hampshire, Nevada, New York, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, North Carolina, New Hampshire, Nevada, New York, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Cell Marque, SOX-10 (Polyclonal), 7 mL A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, North Carolina, New Hampshire, Nevada, New York, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Firebird NXG Spinal Fixation System Decorticating Planer The plastic core of the Decorticating Planer was found to be missing, which could result in scoring of the bone screw neck if used at or beyond a 23 degree… Class IIFDA’s classSep 20, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereCalifornia, Florida and Rhode Island
- Medical device recall Fujifilm Endoscope Fujifilm is reporting a corrective action due to an FDA inspection. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical… Fujifilm is conducting a corrective action due to an FDA inspection. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO)… Software discrepancy of not showing all the EE constants, when the screen is filled. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to… Software discrepancy of not showing all the EE constants, when the screen is filled. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological… The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportMissourithe one state its words name PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereMissouri
- Medical device recall Baxter Amia Automated Peritoneal Dialysis Set with Cassette The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the… Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CS 100i Intra-Aortic Balloon Pump False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 13, 2017ClassClass IStatusOngoingWhereNationwide
- Medical device recall CS 100 Intra-Aortic Balloon Pump False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 13, 2017ClassClass IStatusOngoingWhereNationwide
- Medical device recall CS 300 Intra-Aortic Balloon Pump False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 13, 2017ClassClass IStatusOngoingWhereNationwide
- Medical device recall MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire. Class IIFDA’s classSep 13, 2017in FDA’s Enforcement Report12 statesnamed in where it went PublishedSep 13, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Massachusetts, Michigan, Minnesota, Missouri, New York, Ohio, Utah, Virginia and Wisconsin
- Medical device recall JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of… Three (3) complaints were identified in which the potential for utilization of the JTS Grower Drive in the incorrect orientation in relation to the limb entry… Class IIFDA’s classSep 13, 2017in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 13, 2017ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Kansas, Michigan, New Jersey, Ohio, Pennsylvania, South Carolina and Texas
- Medical device recall Merge Unity software, formerly known as DR Systems Unity PACS software The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation. Class IIFDA’s classSep 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 13, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide” 22GA 1¿ inch Needles. Class IIFDA’s classSep 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 13, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients. Class IIFDA’s classSep 13, 2017in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedSep 13, 2017ClassClass IIStatusTerminatedWhereIllinois
- Medical device recall MOSAIQ Medical Charged-Particle Radiation Therapy System The table shift in the vertical direction was inverted during the use of CMA (Couch Move Assistant). Class IIFDA’s classSep 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 13, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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 named
- Medical device recall Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit Specific lots have been reported to produce falsely lower than expected results for Vitamin D Class IIFDA’s classSep 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 13, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated… Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. Class IIFDA’s classSep 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 13, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the… Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. Class IIFDA’s classSep 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 13, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall iVue with Normative Database, Device Listing Number D185549 FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). Class IIFDA’s classSep 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall iFusion, Device Listing Number D203271 FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). Class IIFDA’s classSep 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall iVue 500 with iScan, D216606 FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). Class IIFDA’s classSep 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of… When performing the Stitching function on GU60A system, unintended area is exposed to radiation Class IIFDA’s classSep 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software… Software defect Class IIFDA’s classSep 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used… Software defect Class IIFDA’s classSep 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System The issue was identified as a firmware problem with the generator. Class IIFDA’s classSep 6, 2017in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Iowa, Illinois, Louisiana, Minnesota, Mississippi, North Carolina, New Jersey, South Carolina, Texas, West Virginia and Wyoming
- Medical device recall CADD(R) Medication Cassette Reservoir with clamp and female Luer The medication cassette reservoir, part number 21-7002-24, with lot number 16X659, may have been manufactured with the incorrect pressure plate and the tubing… Class IIFDA’s classSep 6, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on… Potential failure in the balloon bond in the inner catheter stem, leading to the separation of the balloon from the inner stem, leaving it in the rectal cavity. Class IIFDA’s classSep 6, 2017in FDA’s Enforcement Report5 statesnamed in where it went PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereCalifornia, Florida, Iowa, Idaho and Texas
- Medical device recall POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE Inadequate detectability of radiopaque stripes Class IIFDA’s classSep 6, 2017in FDA’s Enforcement Report5 statesnamed in where it went PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Kansas, Texas and Virginia
- Medical device recall POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT Inadequate detectability of radiopaque stripes Class IIFDA’s classSep 6, 2017in FDA’s Enforcement Report5 statesnamed in where it went PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Kansas, Texas and Virginia
- Medical device recall VITEK¿ 2 Compact 15 Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards… Class IIFDA’s classSep 6, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall VITEK¿ 2 Compact 30 Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards… Class IIFDA’s classSep 6, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Fogarty Adherent Clot Catheter The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm. Class IIFDA’s classSep 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Burn Sheet, sterile - 60” x 96” Burn Sheet has possibility of being shredded. Class IIFDA’s classSep 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereNationwide, and Kentucky, Maryland, New York, Pennsylvania and Virginia named
- Medical device recall MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile… The sleeve seam of the breathable material was found to have inconsistent sealing, which has the potential to allow fluid to flow pass through the protective… Class IIFDA’s classSep 6, 2017in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedSep 6, 2017ClassClass IIStatusOngoingWhereIllinois
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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