Medical devices, 2019
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2,801 medical device recalls FDA’s Enforcement Report published in 2019, 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.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532 Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in… Class IIFDA’s classJan 2, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereArkansas, Florida, Georgia, Maryland, Oklahoma and Virginia
- Medical device recall NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10 The NeoSpan Compression Staple (10x10x10) kits from two lots contain the wrong size drill bit. Class IIFDA’s classJan 2, 2019in FDA’s Enforcement Report11 statesnamed in where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri, North Carolina, New Jersey, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of… Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays Class IIFDA’s classJan 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate… Recalled by FDA on Jan 2, 2019 Class IIFDA’s classJan 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the… Recalled by FDA on Jan 2, 2019 Class IIFDA’s classJan 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement… Recalled by FDA on Jan 2, 2019 Class IIFDA’s classJan 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement… Recalled by FDA on Jan 2, 2019 Class IIFDA’s classJan 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the… Recalled by FDA on Jan 2, 2019 Class IIFDA’s classJan 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HydroSet XT Injectable HA Bone Cement Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19 Class IIFDA’s classJan 2, 2019in FDA’s Enforcement Report19 statesnamed in where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereColorado, Florida, Georgia, Iowa, Massachusetts, Maine, Michigan, Minnesota, North Carolina, North Dakota, New Hampshire, New York, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Wisconsin and West Virginia
- Medical device recall HydroSet XT Injectable HA Bone Cement Incorrect expiry date of 9-Feb-20 Correct expiry date is 30-Aug-19 Class IIFDA’s classJan 2, 2019in FDA’s Enforcement Report19 statesnamed in where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereColorado, Florida, Georgia, Iowa, Massachusetts, Maine, Michigan, Minnesota, North Carolina, North Dakota, New Hampshire, New York, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Wisconsin and West Virginia
- Medical device recall RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and… Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and… Class IIFDA’s classJan 2, 2019in FDA’s Enforcement Report30 statesnamed in where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin
- Medical device recall GEM Coupler Forceps, GEM4183C Potential presence of rust on Coupler Forceps (GEM4183C). Class IIFDA’s classJan 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJan 2, 2019ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Kansas, Louisiana, Massachusetts, Mississippi, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18’’ x 18’’ pre-washed with bands without handles, 5… Potential compromise of product sterility due to breach of sterile barrier. Class IIFDA’s classJan 2, 2019in FDA’s Enforcement Report5 statesnamed in where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereMassachusetts, Michigan, Minnesota, New York and Washington
- Medical device recall ABL800 analyzer The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur. Class IIFDA’s classJan 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic MiniMed 630G 6025805-003_C Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. Class IIFDA’s classJan 2, 2019in FDA’s Enforcement Report52 statesnamed in where it went PublishedJan 2, 2019ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall I-View¿ Contrast Enhanced Digital Mammography, ASY-08109 Calibration issue not possible to visualize contrast uptake in the subtracted mammography images Class IIFDA’s classJan 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MOSAIQ Oncology Information System Version 2.64 If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the… Class IIFDA’s classJan 2, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 2, 2019ClassClass IIStatusTerminatedWhereNo state 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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