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 PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller… Medtronic Navigation is recalling certain components of the PoleStar system (N20 / N30) because of misplaced ground pins which may cause electrical shock to… Class IIFDA’s classJul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two… To warn customers that Custom Ultrasonics, Inc. Class IIFDA’s classJul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and 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, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall GE Healthcare, Discovery MR750w GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report38 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereAlaska, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter First aid kits or rescue kits are recalled because they contains the CPR Shield with One Way Valve and Barrier Filter (mask) and this mask is cleared only for… Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report23 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Maryland, Minnesota, Missouri, Montana, Nebraska, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Utah, Virginia, Washington and Wisconsin
- Medical device recall 5195GM, Cadillac First Aid Kit, #23459698, brand General Motors Cadillac First Aid Kit is recalled because it contains the CPR Shield with One Way Valve and Barrier Filter (mask) and this mask is cleared only for… Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report23 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Maryland, Minnesota, Missouri, Montana, Nebraska, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Utah, Virginia, Washington and Wisconsin
- Medical device recall Image1 SPIES X-LINK Camera Control Unit (CCU), Product Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera head are used in conjunction with the DCI Video Mediastinocope… Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report21 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereArkansas, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, Pennsylvania, Tennessee, Texas and Wisconsin
- Medical device recall MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan 3T (MRT-3010,… A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System. Class IIFDA’s classJul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in… Class IIFDA’s classJul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts and Tennessee named
- Medical device recall HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature… Products are marketed without a cleared 510k. Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report26 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Florida, Georgia, Kansas, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue DePuy Synthes is voluntarily initiating a recall due to affected devices being distributed and or labeled with MR Safety information that does not meet the… Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report50 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereAlaska, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy Presence of leaks near top of the PrismaSate bags Class IIFDA’s classJul 6, 2016in FDA’s Enforcement Report32 statesnamed in where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Bigger-Better-Bladder With 3/8” ID tubing, ITEM BBB38 The seal between the balloon and the housing may leak. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Michigan, New York, Pennsylvania, Texas and Virginia
- Medical device recall ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide The pouch label was missing the use by date (UBD) of 2018-04. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MOSAIQ Oncology Information System It is possible that that the selected Plan-of-the Day could be accidently changed by scrolling the mouse wheel up and down and inadvertently selecting another… Class IIFDA’s classJul 6, 2016in FDA’s Enforcement Report22 statesnamed in where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereAlaska, Arizona, California, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Missouri, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement Report36 statesnamed in where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement Report36 statesnamed in where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Symbiq One Channel Infuser Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Symbiq Two Channel Infuser Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only… Exterior carton is mis-labeled as Sterile. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Florida, Georgia, Massachusetts, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Texas and Virginia named
- Medical device recall *** 1) Product labeled in part: List No. 14212-28 Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall *** 1) Product labeled in part: 14951-48 Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall *** 1) Product labeled in part: List No. 14220-28 Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall *** 1) Product labeled in part: 19734-28 Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall *** 1) Product labeled in part: 19683-28 Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in… Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereIllinois, Michigan, Minnesota, New Jersey and New York
- Medical device recall Alaris System PC Unit A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module… Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial… Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope’s… Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal… Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope’s… Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope’s… Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal… Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope’s… Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Confocal GI Scope Intended to provide optical visualization of an therapeutic access to the Gastrointestinal… Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope’s… Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Cystoscope Intended to provide optical visualization of and therapeutic access to the Urinary Tract Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope’s… Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal… Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope’s… Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Intubation Scope Intended to provide optical visualization of, therapeutic access to, and use to facilitate… Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope’s… Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Laryngo Stroboscope Product Usage Intended to provide optical visualization of, therapeutic access to, the… Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope’s… Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic access to, the Upper… Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope’s… Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Signmoidoscope Intended to provide optical visualization of, therapeutic access to, the Lower… Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope’s… Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and… Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope’s… Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and… Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope’s… Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Ureteroscope Intended to provide optical visualization of and therapeutic access to the Urinary Track Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope’s… Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Esophagoscope Gastrointestinal Tract Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope’s… Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Small Bowel Scope Gastrointestinal Tract Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope’s… Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CENTURION Vision System The grounding pin within the Power Entry Switch on certain systems was susceptible to detachment when the AC power cable is removed. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereIllinois
- Medical device recall K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System The K-wire is used… The affected K-wires do not meet specification requirements. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Mississippi, New York, Oklahoma, Pennsylvania, Texas and Washington named
- Medical device recall Saw Sagittal Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement Report20 statesnamed in where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Massachusetts, Maryland, North Carolina, New Hampshire, New York, South Carolina, Tennessee, Texas and Utah
- Medical device recall Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle… As a result of an internal review of all labeling for the Cadence System, it was determined that the outer package label for the Size 5 Left Tibial Tray… Class IIFDA’s classJul 6, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Pennsylvania
- Medical device recall Hettich Centrifuge Modules: StreamLAB Centrifuge Module Premature bucket failures Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Syngo.plaza, Picture archiving and communication system (PACS) Software error in previous software versions in which two references for the same image may exist in the database. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement Report20 statesnamed in where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, Texas and Wisconsin
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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