Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, 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.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall LIFEPAK 1000 defibrillator Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly… Class IIFDA’s classJun 4, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 4, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic Temporary Pacemaker Events related to a pacing rate outside of the intended setting, including events of sudden increased pacing rate up to the maximum setting of 180 pulses per… Class IIFDA’s classJun 4, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 4, 2014ClassClass IIStatusTerminatedWhereGuam and Puerto Rico
- Medical device recall IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR)… Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service. Class IIFDA’s classJun 4, 2014in FDA’s Enforcement ReportSouth Carolinathe one state its words name PublishedJun 4, 2014ClassClass IIStatusTerminatedWhereSouth Carolina
- Medical device recall MAGNETOM Aera magnetic resonance system Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manuals. Class IIFDA’s classJun 4, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 4, 2014ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Iowa, Minnesota and Texas
- Medical device recall Visitec Anterior Chamber Cannula, .40x22mm Contains a sharp tip needle when the product should contain a blunt tip cannula Class IIFDA’s classJun 4, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 4, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Connecticut, Indiana, North Carolina, New York, Texas and Virginia named
- Medical device recall The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic… It has been identified that in a reject image workflow where multiple studies are simultaneously opened on the Centricity PACS RA1000 workstation and images… Class IIFDA’s classJun 4, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJun 4, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to… B.Braun Medical, Inc. Class IIFDA’s classJun 4, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 4, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) - may incorrectly display the color flow data in the wrong position and when… Class IIFDA’s classJun 4, 2014in FDA’s Enforcement Report30 statesnamed in where it went PublishedJun 4, 2014ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software version 3.5 (VA35) when using the stress echo feature which… Class IIFDA’s classJun 4, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 4, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x… Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use. Class IIFDA’s classJun 4, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 4, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARCHITECT Intact PTH Calibrators consists of 6 bottles Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Class IIFDA’s classJun 4, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 4, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Georgia and Puerto Rico named
- Medical device recall ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Class IIFDA’s classJun 4, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 4, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Georgia and Puerto Rico named
- Medical device recall Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump Potential mechanical failure of the fan assembly associated with the power supply. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display,… A complaint reported that the archiving method at one customer site was changed from implicit to explicit, and the cleanup procedure enabled by the explicit… Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U-R FLOW-POUCH… The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List… Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMay 28, 2014ClassClass 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible… The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List… Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMay 28, 2014ClassClass 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder… The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List… Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMay 28, 2014ClassClass 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container… The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List… Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMay 28, 2014ClassClass 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216… The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List… Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMay 28, 2014ClassClass 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors The risk of battery failure increases with age, when a battery remains in use longer than 3 years after date of manufacture or 500 charge-discharge cycles. Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling… The Irrigation Clips were assembled with the incorrect (smaller) clips. Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereNationwide, and Mississippi named
- Medical device recall JK Bariatric Beds, True Air Technologies, Inc. The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors. Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Kentucky and Michigan named
- Medical device recall ECATS E 850 Bariatric Bed, True Air Technologies, Inc. The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors. Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Kentucky and Michigan named
- Medical device recall MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc. The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors. Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Kentucky and Michigan named
- Medical device recall Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter… The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportMichiganthe one state its words name PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereMichigan
- Medical device recall CDI Blood Parameter Monitoring System There is a potential for inaccuracies in blood gas readings/measurements. Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportIowathe one state its words name PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereIowa
- Medical device recall Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew… Grasper jaw may break when force is applied to the jaw Class IIFDA’s classMay 28, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereIllinois, New York, Tennessee and Texas
- Medical device recall TRIGEN INTERTAN NAIL A manufacturing error resulted in the set screw being inserted too deep in the affected nails. Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall TRIGEN INTERTAN 1.5 NAIL A manufacturing error resulted in the set screw being inserted too deep in the affected nails. Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MAMMOMAT Inspiration There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor… Class IIFDA’s classMay 28, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereFlorida, Georgia, Massachusetts, Nevada and New York
- Medical device recall Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Naturalyte Liquid Bicarbonate maybe contaminated FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2014ClassClass IStatusOngoingWhereNationwide
- Medical device recall GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module… When the E-NMT-01 module is used in conjunction with the ElectroSensor, the Neuromuscular Transmission (NMT) values may indicate a deeper level of muscle… Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nevada, New York, Ohio, Oklahoma, Tennessee, Texas, Utah, Washington, Wisconsin and Wyoming named
- Medical device recall MXR-35 Diagnostic X-ray High Voltage Generator The MXR-35 X-ray Generator’s labeling did not include the certification statement as required by 21 CFR Part 10 10.2. Class IIFDA’s classMay 28, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereKentucky and Texas
- Medical device recall Polyflux Revaclear, Capillary Dialyzer The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013. Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 28, 2014ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Polyflux Revaclear Max, Capillary Dialyzer The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013. Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 28, 2014ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall 550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic… Table may lose calibration during patient treatment, which may cause the possibility of mistreatment. Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology… When using XIRIS Rio version (8.1.50.0) in conjuncture with iSite PACS a synchronization error can occur and if not noticed, information for the incorrect… Class IIFDA’s classMay 28, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereFlorida and Texas
- Medical device recall Dimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative… A complaint was received of Dimension Vista¿ CSA and CSAE under-recovery of cyclosporine when patient samples are run from the Small Sample Container. Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma… Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results. Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Esmark Elastic Bandage (Sterile), 4” x 9’ This lot did not go through the correct sterilization procedures. Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Iowa, Illinois, Indiana, Kentucky, Louisiana, Michigan, Mississippi, New Jersey, New York, Ohio, Pennsylvania, Texas and Washington named
- Medical device recall SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket The hose could separate from the blanket. Class IIFDA’s classMay 28, 2014in FDA’s Enforcement Report9 statesnamed in where it went PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Kentucky, Mississippi, North Carolina, Tennessee, Texas, Washington and Wisconsin
- Medical device recall Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device The firm discovered that the Gluma Desensitizer Power Gel can be inadvertently extruded from the application syringe all at once when it is supposed to extrude… Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall ABACUS TPN Calculation Software 1. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 21, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 21, 2014ClassClass IStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with “Delay Until” Option and… CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 21, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall MedStream Programmable Infusion Pump, 20 mL A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life. Class IIFDA’s classMay 21, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 21, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MedStream Programmable Infusion Pump, 40 mL A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life. Class IIFDA’s classMay 21, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 21, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0 When an isolate is resulted without a SNOMED code, isolate information in the downstream system may be incomplete or missing. Class IIFDA’s classMay 21, 2014in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedMay 21, 2014ClassClass IIStatusTerminatedWhereIllinois
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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