Medical devices, 2021
Shortlist up to four to read them side by side.
2,303 medical device recalls FDA’s Enforcement Report published in 2021, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall REF 69655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F,… Catheters contain two issues: 1. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall REF 91660417, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Tip, Basic… Catheters contain two issues: 1. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F,… Catheters contain two issues: 1. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall REF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet, Full Kit,… Catheters contain two issues: 1. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall REF 7617405, Groshong NXT ClearVue Catheter Basic Kit, 4F, Single-Lumen, 60 cm, UDI Catheters contain two issues: 1. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall REF 7617407, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI Catheters contain two issues: 1. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall ASSURITY Pulse Generator Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedMay 19, 2021ClassClass IStatusOngoingWhereNationwide, and Alaska, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ENDURITY Pulse Generator Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedMay 19, 2021ClassClass IStatusOngoingWhereNationwide, and Alaska, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis… AquaBplus HF module on the AquaBplus 2500 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedMay 19, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New York, Pennsylvania, Puerto Rico, South Carolina, Tennessee and Texas named
- Medical device recall Revogene SARS-CoV-2 Emergency Use Application (EUA) application withdrawn as false negative results reported Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 19, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Emergency Use Application (EUA) application withdrawn as false negative results reported Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 19, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Regard Dressing Change Tray ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity. Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 19, 2021ClassClass IIStatusTerminatedWhereNationwide, and Louisiana named
- Medical device recall Alaris Pump Module Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 19, 2021in FDA’s Enforcement ReportIowathe one state its words name PublishedMay 19, 2021ClassClass IStatusTerminatedWhereIowa
- Medical device recall Alaris Pump Module Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 19, 2021in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMay 19, 2021ClassClass IStatusOngoingWhereCalifornia
- Medical device recall NM/CT 850 Nuclear Medicine / CT Scanners GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NM/CT 860 Nuclear Medicine / CT Scanners GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NM/CT 870 DR Nuclear Medicine / CT Scanners GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for… Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma. Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedMay 19, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Idaho, Illinois, Michigan, Minnesota, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Virginia and Wisconsin named
- Medical device recall NeuroTherm NT2000iX Radiofrequency (RF) Generator Potential capacitor failure which typically manifests as in inability to provide output on one or more channels. Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 19, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall PowerPort duo M.R.I Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements. Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedMay 19, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall PowerPort duo M.R.I Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements. Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedMay 19, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall PowerPort duo M.R.I Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements. Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedMay 19, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part… ReWalk Robotics received two complaints (one in the US; one in the Germany), which alleged that the ReWalk device waistpack (which is the location of the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 19, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Kit: CentralLineDresChangeClrSeq MAI Kit Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 19, 2021ClassClass IStatusTerminatedWhereNationwide, and California, Florida, Ohio and Oregon named
- Medical device recall Kit: Injection REVIEW MAI Kit Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 19, 2021ClassClass IStatusTerminatedWhereNationwide, and California, Florida, Ohio and Oregon named
- Medical device recall Kit: Midline Insertion DA Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 19, 2021ClassClass IStatusTerminatedWhereNationwide, and California, Florida, Ohio and Oregon named
- Medical device recall Kit: LVAD Dres Chg Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 19, 2021ClassClass IStatusTerminatedWhereNationwide, and California, Florida, Ohio and Oregon named
- Medical device recall Kit: Blood Culture Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 19, 2021ClassClass IStatusTerminatedWhereNationwide, and California, Florida, Ohio and Oregon named
- Medical device recall Kit: Blood Culture MAI Kit Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 19, 2021ClassClass IStatusTerminatedWhereNationwide, and California, Florida, Ohio and Oregon named
- Medical device recall Eyesuite 9.3.1 software, LENSTAR Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Pacific Coast and Laser Institute (PCLI). Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Washington named
- Medical device recall Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in… The media allows growth of E. Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedMay 19, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Georgia, Iowa, Illinois, Indiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas and Virginia named
- Medical device recall AFT Straight Tube 3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 19, 2021ClassClass IIStatusTerminatedWhereNationwide, and Minnesota named
- Medical device recall Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. Class IIFDA’s classMay 19, 2021in FDA’s Enforcement Report15 statesnamed in where it went PublishedMay 19, 2021ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, District of Columbia, Illinois, Indiana, Massachusetts, Maryland, Minnesota, Mississippi, Nebraska, New Jersey, New York, Oregon, Texas and Virginia
- Medical device recall VenaSeal Closure System Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter. Class IIIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMay 19, 2021ClassClass IIIStatusTerminatedWhereNationwide, and Massachusetts, Maine, New Hampshire, New York and Vermont named
- Medical device recall REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF CH3582 5 IN Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF 20124-01 30” Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the… Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a… Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF CL3011 30” Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF CL3028T 30” Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF CL3538 Oncology Kit w/5” Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF CL3946 Oncology Kit w/5” Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF CL3960 Oncology Kit w/60” Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF CL4151 45” Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of… Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of… Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF CH3011 30” Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
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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