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 Anspach MCA Cutting Burr, DFU Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Locking Cortical Screw 3.5mmX38mm 3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a… Class IIFDA’s classJan 22, 2014in FDA’s Enforcement Report15 statesnamed in where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereArizona, California, Georgia, Illinois, Kentucky, Michigan, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, South Dakota, Texas, Utah and Virginia
- Medical device recall Leica BIOSYSTEMS The affected lots of the product may contain a contaminant of fungus that can cause a loss of staining sensitivity and/or obstructions to fluid delivery to the… Class IIFDA’s classJan 22, 2014in FDA’s Enforcement Report40 statesnamed in where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips Recall was initiated due to the observation of separation between clear layers of the pouch during real time aging studies. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN):… Sterility of device may be compromised due to lack of pouch seal integrity Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN):… Sterility of device may be compromised due to lack of pouch seal integrity Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product Number… Sterility of device may be compromised due to lack of pouch seal integrity Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN):M00561420 Sterility of device may be compromised due to lack of pouch seal integrity Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN):M00561421 Sterility of device may be compromised due to lack of pouch seal integrity Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used in flexible… Sterility of device may be compromised due to lack of pouch seal integrity Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems There exists a software issue associated with patient selection from the worklist on the Optima XR200 with Digital Upgrade, and Optima XR220amx Mobile X-ray… Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Guam named
- Medical device recall Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide… Some carbide cutting burr fractured during use. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide, and Hawaii named
- Medical device recall Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted… Some carbide cutting burr fractured during use. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide, and Hawaii named
- Medical device recall Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Drum part # S-15DRMC Anspach cutting… Some carbide cutting burr fractured during use. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide, and Hawaii named
- Medical device recall Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted… Some carbide cutting burr fractured during use. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide, and Hawaii named
- Medical device recall Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20… The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the outer… Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centricity PACS… There is a potential loss of image(s) associated with the Centricity to Centricity (C2C) exam transfer module of Centricity PACS System versions 3.X and higher… Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, 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, West Virginia and Wyoming named
- Medical device recall Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use High positive calcium bias on plasma sample versus results on serum Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative… High positive calcium bias on plasma sample versus results on serum Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Oxoid Antimicrobial Susceptibility Testing Disc, MEM10 Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Hawaii, Iowa, Illinois, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line… Chest Drain tubing of of the ATS Blood recovery may leak or disconnect Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile… Chest Drain tubing of of the ATS Blood recovery may leak or disconnect Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery… Chest Drain tubing of of the ATS Blood recovery may leak or disconnect Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with… Chest Drain tubing of of the ATS Blood recovery may leak or disconnect Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with… Chest Drain tubing of of the ATS Blood recovery may leak or disconnect Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line… Chest Drain tubing of of the ATS Blood recovery may leak or disconnect Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain Dual patient lines Chest Drain tubing of of the ATS Blood recovery may leak or disconnect Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain Chest Drain tubing of of the ATS Blood recovery may leak or disconnect Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak… Chest Drain tubing of of the ATS Blood recovery may leak or disconnect Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STERRAD NX Sterilization System Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected… Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STERRAD 50 Sterilization System Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected… Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STERRAD 100S Sterilization System Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected… Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide… GE Healthcare has recently become aware of a potential safety issue due to intermittent failure of the spring loaded mounting latch of PDMs produced from… Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers… There is a potential safety issue with the 8.0.2 version software of the Merge (Cedara) Mammo viewer. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement Report17 statesnamed in where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereAlaska, Arkansas, California, Iowa, Idaho, Illinois, Michigan, Mississippi, Montana, New Jersey, Nevada, New York, Oregon, Pennsylvania, South Carolina, Tennessee and Wisconsin
- Medical device recall Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001 The Anspach Effort, Inc. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MCA5-05SD - 0.5 MM Diamond Ball, 5.6CM The Anspach Effort, Inc. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MCA5-06SD - 0.6MM Diamond Ball, 5.6CM The Anspach Effort, Inc. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MCA5-07SD - 0.7MM Diamond Ball, 5.6CM The Anspach Effort, Inc. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MCA5-08SD - 0.8MM Diamond Ball, 5.6CM The Anspach Effort, Inc. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MCA5-15SB - 1.5MM Fluted Ball, 5.6CM The Anspach Effort, Inc. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MCA5-15SD - 1.5MM Diamond Ball, 5.6CM The Anspach Effort, Inc. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MCA5-1SB - 1MM Fluted Ball, 5.6CM The Anspach Effort, Inc. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MCA5-1SD - 1MM Diamond Ball, 5.6CM The Anspach Effort, Inc. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MCA5-2SB - 2MM Fluted Ball, 5.6CM The Anspach Effort, Inc. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MCA5-2SD - 2MM Diamond Ball, 5.6CM The Anspach Effort, Inc. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MCA7-05SD - 0.5MM Diamond Ball, 7.3CM The Anspach Effort, Inc. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MCA7-06SD - 0.6MM Diamond Ball, 7.3CM The Anspach Effort, Inc. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MCA7-07SD - 0.7MM Diamond Ball, 7.3CM The Anspach Effort, Inc. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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