Medical devices, 2015
Shortlist up to four to read them side by side.
2,495 medical device recalls FDA’s Enforcement Report published in 2015, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 7, 2026.
2,495of 2,495 medical device recallsshown with your filters
The list
- Medical device recall Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc) Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a… Class IIFDA’s classFeb 25, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 25, 2015ClassClass IIStatusTerminatedWhereTexas and Virginia
- Medical device recall Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component. Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a… Class IIFDA’s classFeb 25, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 25, 2015ClassClass IIStatusTerminatedWhereTexas and Virginia
- Medical device recall R¿SCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is designated for oral or nasal… Teleflex Medical has issued an advisory notification for the RUSCH Curved Reinforced Endotracheal Tube because of a discrepancy between the labeled cuff… Class IIFDA’s classFeb 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used… Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application. Class IIIFDA’s classFeb 25, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 25, 2015ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery. Class IIFDA’s classFeb 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MC-500 Multicolor Laser Photocoagulator The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself. Class IIFDA’s classFeb 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedFeb 25, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Iowa, Illinois, Kansas, Michigan, New Hampshire, New York, Texas, Utah and Wisconsin named
- Medical device recall Restoris Partial Knee Application (PKA) RIO (TGS 2.0) When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control… Class IIFDA’s classFeb 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedFeb 25, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Cold Therapy Pad - cold water circulating pad, one unit per package Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak. Class IIFDA’s classFeb 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 25, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Mexico, Ohio, Pennsylvania, Tennessee, Virginia, Washington and Wisconsin named
- Medical device recall Haemonetics TEG Hemostasis System Level II Control Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are outside of the manufacturer’s expected Quality Control range for… Class IIFDA’s classFeb 25, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 25, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MAQUET Servo Humidifier 163 Connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in the breathing circuit. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 18, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 18, 2015ClassClass IStatusTerminatedWhereFlorida, Kansas, Michigan and West Virginia
- Medical device recall MAQUET, SERVO Humidifier 163 Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 18, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 18, 2015ClassClass IStatusTerminatedWhereFlorida, Kansas, Michigan and West Virginia
- Medical device recall CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ACUSON S2000 Automated Breast Volume Scanner (ABVS) There is a low probability the scanner arm will become completely detached from the scanner column. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereMinnesota, Puerto Rico and Texas
- Medical device recall Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients. There is a potential for unintended and erratic motion. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall SoftPath Laboratory Information System Modifications to diagnostic text may be: 1) Saved to the database but not appear on the report sent to the physician; or 2) Documented on the report, but not… Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall System 6 Aseptic Housing Stryker is recalling System 6 Aseptic Housing, due to a failed Continuous Bond Line Test from a housing without a continual weld. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Florida, Georgia, Hawaii, Maryland, North Carolina, New York, Pennsylvania, Puerto Rico, South Carolina, Texas and Virginia named
- Medical device recall EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials… Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing… Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute… Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing… Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm due to oversize of the set screw hex feature. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereIndiana, Missouri, New York and Texas
- Medical device recall Aquarius iNtuition Client Viewer Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The SurgiWrap Bioresorbable Adhesion Barrier Film The expiration date of the bar code on the envelope label did not match the expiration date next to the hourglass. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte… A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled with an incorrect expiration date of 2412-12-01. Class IIIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedFeb 18, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, Iowa, Illinois, Indiana, Louisiana, Massachusetts, North Carolina, Nebraska, New Mexico, South Carolina, Tennessee, Texas, Wisconsin and West Virginia named
- Medical device recall Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; The correct product labeling is uncuffed nasal ET tube. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement Report12 statesnamed in where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereFlorida, Georgia, Illinois, Kentucky, Massachusetts, Michigan, Missouri, Mississippi, Ohio, Texas, Washington and West Virginia
- Medical device recall ARROW Epidural Needle Component (product number AN-05501) The product labeling does not specify the 5 year shelf life of the product. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VisiPlugST for the Lacrimal Efficiency Test Moisture level may cause the VisiPlugST (or CollaSyn Plugs) to break apart, or crumble upon contact. Class IIIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedFeb 18, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Arkansas, California, Florida, Idaho, Illinois, Kansas, Massachusetts, Michigan, North Carolina, New Jersey, New York, Oregon, Pennsylvania and Texas named
- Medical device recall ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit Foreign material found within the kits. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 Drug products contained within the kits may have been rendered ineffective by a duplicate sterilization process. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package Through an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during use. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide, 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, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: Achieve and… The labelling of units from the affected lot indicates that it contains a size 5 LMA Supreme (New Cuff), but may contain a size 4 LMA Supreme (New Cuff). Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Delaware, Florida, Georgia, Illinois, Kentucky, Missouri, New York, Oklahoma, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of… There is a potential for the linear bearing car to fail allowing the ball bearings to fall out. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall The Siemens Symbia T series is intended to aid in detecting, localizing, diagnosing, staging and restaging of… There is a potential for the linear bearing car to fail allowing the ball bearings to fall out. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic… Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement Report9 statesnamed in where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereArizona, California, Florida, Kansas, Louisiana, Minnesota, Missouri, North Carolina and New York
- Medical device recall Telluride Percutaneous Rod Inserter Long The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in place during use. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNebraska, New York, Ohio and Texas
- Medical device recall MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm Potential for implant damage, implant cracking off/breaking intra-operatively. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block, sheet and pre-formed… Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking… Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are… Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking… Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Product Usage: MEDPOR… Article #81036 (MEDPOR Titan Max OFW - MTB - Right) reportedly contained article #81035 MEDPOR Titan Max OFW - MTB - Left. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding… Revision A of the Hemostatic Bone Putty Brochure (J10847A) was sent to sales consultants instead of Revision B (J10847B), which corrected an error in the… Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportWisconsinthe one state its words name PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereWisconsin
- Medical device recall Hudson RCI¿ Humidifier Adaptor, 040 contained in the following units: HUMIDIFIER ADAPTOR 040 Product Usage:… The packages may contain foreign material (black particles). Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AQUAPAK 101 SW, 190ML W/040 ADAPTOR, JAPA Product Usage: The Humidifier Adaptor is an accessory which allows… The packages may contain foreign material (black particles). Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AQUAPAK 340 SW, 340 ML W/404 ADAPTOR The packages may contain foreign material (black particles). Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI Product Usage: The Humidifier Adaptor is an accessory which allows… The packages may contain foreign material (black particles). Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AQUAPAK SW/EAU STERILE, 340 ML W/ADAPTOR Product Usage: The Humidifier Adaptor is an accessory which allows… The packages may contain foreign material (black particles). Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FREN The packages may contain foreign material (black particles). Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA The packages may contain foreign material (black particles). Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AQUA 540 SW, 540 W/040 ADAPTOR The packages may contain foreign material (black particles). Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AQUAPAK 640 SW, 650ML W/040 ADAPTOR The packages may contain foreign material (black particles). Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AQUAPAK SW/EAU STERILE, 650 ML W/ADAPTOR The packages may contain foreign material (black particles). Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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