Medical devices, 2016
Shortlist up to four to read them side by side.
3,246 medical device recalls FDA’s Enforcement Report published in 2016, 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.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall Cardiosave Hybrid and rescue IABP Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Reveal LINQ insertable Cardiac Monitor Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ ICM that may prematurely trigger the Recommended Replacement… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The… Specific CDI¿ Blood Parameter Monitoring System 500 devices are being voluntarily recalled because the BPM Sensor Head Assemblys Thermistor, which provides… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6… Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus. Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereDelaware, Florida, Kentucky, Michigan, Nebraska, New Jersey and Puerto Rico
- Medical device recall Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2… Innovative Ophthalmic Products (IOP) is recalling the Molteno 3 G-Series Glaucoma Implant the package insert/Instructions for Use (IFU) for the device has been… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mislabeled lordotic angle of 12degrees when the angle is… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 74” (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock Port sterile IV Administration… ICU Medical has identified an issue with a connection in an isolated number of I.V. Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report13 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Massachusetts, Michigan, Missouri, New Jersey, Nevada, Ohio, Texas and Virginia
- Medical device recall 30” (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Bag Hanger,… ICU Medical has identified an issue with a connection in an isolated number of I.V. Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report13 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Massachusetts, Michigan, Missouri, New Jersey, Nevada, Ohio, Texas and Virginia
- Medical device recall 30” (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter,… ICU Medical has identified an issue with a connection in an isolated number of I.V. Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report13 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Massachusetts, Michigan, Missouri, New Jersey, Nevada, Ohio, Texas and Virginia
- Medical device recall 110” (279 cm) Appx 13.8 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Clave, Rotating… ICU Medical has identified an issue with a connection in an isolated number of I.V. Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report13 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Massachusetts, Michigan, Missouri, New Jersey, Nevada, Ohio, Texas and Virginia
- Medical device recall 30” (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber, Spiros, Hanger, Drop-In Red… ICU Medical has identified an issue with a connection in an isolated number of I.V. Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report13 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Massachusetts, Michigan, Missouri, New Jersey, Nevada, Ohio, Texas and Virginia
- Medical device recall 30” (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber,… ICU Medical has identified an issue with a connection in an isolated number of I.V. Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report13 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Massachusetts, Michigan, Missouri, New Jersey, Nevada, Ohio, Texas and Virginia
- Medical device recall 30” (76 cm) Appx. 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter,… ICU Medical has identified an issue with a connection in an isolated number of I.V. Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report13 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Massachusetts, Michigan, Missouri, New Jersey, Nevada, Ohio, Texas and Virginia
- Medical device recall 31” (79 cm) Appx. 3.4 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Spiros, Bag Hanger,… ICU Medical has identified an issue with a connection in an isolated number of I.V. Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report13 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Massachusetts, Michigan, Missouri, New Jersey, Nevada, Ohio, Texas and Virginia
- Medical device recall The E.CAM gamma camera system Product Usage: The E.CAM gamma camera system is a SPECT system and measures the… We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-00002). Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedApr 6, 2016ClassClass 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, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall The Symbia gamma camera system Product Usage: The Symbia gamma camera system is a computed tomography x-ray… We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-00002). Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedApr 6, 2016ClassClass 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, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device Product Usage: Clear Vue… Some of the Access ClearVue Prone Breast devices may contain scales that are misaligned from the zero reference with respect to other Access ClearVue Prone… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, New York, Pennsylvania and Texas named
- Medical device recall Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system The anterior/posterior (AP) dimension may be oversized by 0.016 . Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportUtahthe one state its words name PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereUtah
- Medical device recall The S.C.O.R.E.S Water retention issues. Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report8 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereFlorida, Georgia, Minnesota, New York, Ohio, Oregon, South Carolina and Tennessee
- Medical device recall The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices… Implant Direct Sybron Manufacturing, LLC is recalling GoDirect Implants because some consignees did not receive the correct tool to drive the implant to bone… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah, Washington and Wisconsin named
- Medical device recall Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The product is intended for use by dental… The firm received two customer complaints local Pelton & Crane distributors that the Helios 3000 track mounted dental lights were missing the two 8/32x3/16 set… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Idaho, Illinois, Indiana, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software incorrectly allows the operator to manually edit the… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNorthern Mariana Islands, Puerto Rico and US Virgin Islands
- Medical device recall Medtronic, Model 8781 Ascenda” Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide. Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda” Intrathecal Catheter kit. Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Estradiol III Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not be used when monitoring patient being treated with… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Estradiol II Elecsys and cobas e analyzers Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not be used when monitoring patient being treated with… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Cios Alpha, mobile X-ray system Software issues on Cios Alpha mobile C-Arm system Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector Loss of key image functionality due to a bent pedal of the Footswitch. Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Foot Switches used with the following systems: Philips Allura Xper Systems Loss of key image functionality due to a bent pedal of the Footswitch. Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: The Cios Alpha is a mobile X-ray… Siemens found a defective part in their production line which could increase risk of an electrical shock for service personnel when working inside the device… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Nebraska and Utah named
- Medical device recall Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for… After importing segmentation results of the left atrium created on the Artis One system, the possibility exists for the results to be mirrored to an… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Michigan named
- Medical device recall AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of… Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of… Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Knee Shield (Patella Cup) Product Usage: Knee Shield patella cup is an accessory used with the knee braces to… Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report48 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, 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, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an accessory for comfort under knee braces. Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report48 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, 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, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall NecLoc Extrication Collar Product Usage: Necloc collars are applied to patients afflicted with cervical… Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report48 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, 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, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with cervical injuries to… Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report48 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, 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, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Rebound Cartilage Product Usage: Rebound Cartilage is an external knee brace that provides support for knee… Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report48 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, 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, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an external knee brace that provides… Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report48 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, 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, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Rebound Air Walker Product Usage: Rebound Air Walkers are indicated for grade 2 and grade 3 ankle sprains, to… Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report48 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, 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, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used for the treatment of plantar foot… Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report48 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, 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, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report48 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, 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, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for knee… Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report48 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, 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, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Unloader Custom Lite Product Usage: Unloader Custom Lite is an external knee braces to provide support for… Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report48 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, 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, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Unloader Custom Product Usage: Unloader Custom is an external knee braces to provide support for knee… Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report48 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, 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, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Extreme Custom Product Usage: Extreme Custom is an external knee braces to provide support for knee… Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report48 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, 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, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Papoose Infant Spine Immobilizer Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report48 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, 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, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall system, x-ray, angiographic In Artis zeego systems, angulations in the vicinity of the C-arm collision area can cause the cable inlet to become clamped and can result in mechanical damage. Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Guam, 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, 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 Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce… Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, 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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