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 Catalog Number: 900742A CARPAL TUNEL LARGE SURGICAL PACK Used by medical staff to perform surgical procedures… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900774 INCISION AND DRAINAGE TRAY Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900782 SKIN STAPLE REMOVER STERILE Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900796 FEMORAL ANGIOGRAPHY SURGICAL PACK Used by medical staff to perform surgical procedures… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900921A C-SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900944 CATARACT SURGICAL PACK Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900946 STRABISMUS SURGICAL PACK Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900982 ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900996 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900997 PERI-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900998 CESAREAN SECTION SURGICAL PACK Used by medical staff to perform surgical procedures… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall AMT G-Jet¿ Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY The firm received complaints that the product is shorter in length than indicated on the label. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement Report8 statesnamed in where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereArizona, California, Delaware, Indiana, Michigan, New Mexico, Pennsylvania and Virginia
- Medical device recall GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control. GE Inspection Technologies, LP (“GE”) has discovered that certain of its cabinet x-ray systems may not fully comply with the Food and Drug Administration’s… Class IIFDA’s classApr 13, 2016in FDA’s Enforcement Report24 statesnamed in where it went PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Indiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Ellex Medical Fixed eye Safety filters The Firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 13, 2016ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Hawaii, Iowa, Illinois, Indiana, Massachusetts, Maine, Michigan, Minnesota, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct… Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Hawaii, Iowa, Illinois, Indiana, Massachusetts, Maine, Michigan, Minnesota, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 13, 2016ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Hawaii, Iowa, Illinois, Indiana, Massachusetts, Maine, Michigan, Minnesota, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall Guardian II Hemostasis Valve, models 8210 and 8211 Vascular Solutions became aware of a potential problem with the click version of the Guardian II hemostasis valves. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedApr 13, 2016ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Hampshire, Nevada, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall NEL GBS Medium 20 ml Product marketed without a 510 (k) Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Product marketed without a 510 (k) Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high temperature The firm received a complaint of the battery exploding while recharging. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement Report24 statesnamed in where it went PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Delaware, Florida, Illinois, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and West Virginia
- Medical device recall evaluemed Infant Heel Warmer 301-1223 eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, nor any warning that product used beyond its expected shelf… Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and Ohio named
- Medical device recall eValueMed Infant Transport Mattress 301-1015 eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, nor any warning that product used beyond its expected shelf… Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and Ohio named
- Medical device recall All instrumentation associated with the Prelude PF Resurfacing Knee System. Inadequate design control. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement Report12 statesnamed in where it went PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Georgia, Indiana, Kansas, Michigan, Missouri, North Carolina, New Jersey, Ohio, Tennessee and Texas
- Medical device recall Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use Multiple complaints were received from customers indicating that they ordered product 8335(Type 3 Paraffin) but when they opened the box, they found product… Class IIIFDA’s classApr 13, 2016in FDA’s Enforcement Report12 statesnamed in where it went PublishedApr 13, 2016ClassClass IIIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Michigan, Minnesota, New Mexico, New York, Ohio, Texas and Utah
- Medical device recall Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during… Two lots of Gomco Style Circumcision Clamp Trays, SSI-0034 and 10-1100 contained a 1.3cm circumcision clamp. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Kansas, Mississippi, North Carolina, Texas, Virginia and West Virginia named
- Medical device recall TOPAZ MicroDebrider 0.8 mm During functional testing of devices after real time aging, it was determined that product failed to meet shelf-life at the expiration date indicated on the… Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The THERAKOS CELLEX Photopheresis System is a photoimmune therapy The Mallinckrodt (Therakos) post-market monitoring process detected an increased trend in tubing leaks within the pump tubing organizer, associated with a… Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, District of Columbia, Florida, Idaho, Illinois, Indiana, Massachusetts, Maine, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont and Wisconsin named
- Medical device recall MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula Complaints that the cannula bent/broke during surgery. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Fresenius Hemoflow F3 Dialyzer Dialyzer header leak due to possible improper torque Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, District of Columbia, Georgia, Illinois, Indiana, Michigan, Minnesota, Missouri, Mississippi, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Texas and Washington named
- Medical device recall Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius… Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When Dialyzing Patients Treated with Hydroxocobalamin (or any form… Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Titanium Low Profile Neuro Screw, Self Drilling, 3mm Out of specification at the thread. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Connecticut, Georgia, Iowa, Massachusetts, New Jersey, New York, Pennsylvania, Tennessee, Virginia, Vermont and Washington named
- Medical device recall Titanium Low Profile Neuro Screw, Self Drilling, 3mm Out of specification at the thread. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Connecticut, Georgia, Iowa, Massachusetts, New Jersey, New York, Pennsylvania, Tennessee, Virginia, Vermont and Washington named
- Medical device recall MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device MicroAire has initiated a recall on product PAL-R4011XL (40cm x 4mm Del Vecchio French Rasp cannula), due to our receipt of three (3) complaints that it bent… Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CA500 Epix Universal Clip Applier Product Usage: The Epix disposable laparoscopic clip applier is indicated… Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit… Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Georgia, Idaho, Louisiana, Minnesota, New Mexico, Oregon, Texas, Utah and Wyoming named
- Medical device recall STD GK258, AME Standard Kit 44 Product Usage: The Epix disposable laparoscopic clip applier is indicated for… Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit… Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Georgia, Idaho, Louisiana, Minnesota, New Mexico, Oregon, Texas, Utah and Wyoming named
- Medical device recall STD KIT GK213, AME Standard Kit 15 Product Usage: The Epix disposable laparoscopic clip applier is indicated… Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit… Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Georgia, Idaho, Louisiana, Minnesota, New Mexico, Oregon, Texas, Utah and Wyoming named
- Medical device recall STD KIT GK260, Standard Set 360 Z Product Usage: The Epix disposable laparoscopic clip applier is indicated… Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit… Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Georgia, Idaho, Louisiana, Minnesota, New Mexico, Oregon, Texas, Utah and Wyoming named
- Medical device recall ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various… Endoscope cleaning brush 11276CL may not fit resulting in an inability to insert the brush in to the channel of the intended endoscope or to completely pass it… Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement Report19 statesnamed in where it went PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Georgia, Hawaii, Idaho, Kansas, Louisiana, Massachusetts, Minnesota, Missouri, New York, Ohio, Oklahoma, Pennsylvania, Texas, Utah, Virginia and Wisconsin
- Medical device recall Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For… The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement Report19 statesnamed in where it went PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Georgia, Hawaii, Idaho, Kansas, Louisiana, Massachusetts, Minnesota, Missouri, New York, Ohio, Oklahoma, Pennsylvania, Texas, Utah, Virginia and Wisconsin
- Medical device recall NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts, South Carolina and Texas named
- Medical device recall NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts, South Carolina and Texas named
- Medical device recall NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts, South Carolina and Texas named
- Medical device recall NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts, South Carolina and Texas named
- Medical device recall SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is a whole body magnetic resonance scanner designed… Ferrous material in the SIGNA Pioneer Table Control Box (TCB) could cause unexpected attraction to the MR system’s high strength magnetic field during… Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and North Carolina and South Carolina named
- Medical device recall VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110 The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be de-energized will… Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate,… To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Connecticut, Florida, Iowa, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas and Wisconsin 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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