Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, 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 6, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable… Class IIFDA’s classMay 30, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereCalifornia, Massachusetts, Minnesota, Missouri and New Jersey
- Medical device recall ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereFlorida, Georgia, Maryland, Michigan, North Carolina, New York, Oregon, Texas, Utah and Virginia
- Medical device recall smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Prismaflex System Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a… Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 30, 2018ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Prismaflex 5.10 US Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a… Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 30, 2018ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Prismaflex 7.XX ROW Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a… Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 30, 2018ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Prismaflex 7.XX US Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a… Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 30, 2018ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Prismaflex 7.20 US Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a… Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 30, 2018ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the… Getinge has received complaints concerning the X TEN Surgical Lights whose spring arms have broken, causing light heads to separate from the assembly. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Edwards Lifesciences’ IntraClude Intra-Aortic Occlusion Device Possible leak at distal open end of the strain relief, which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate… Class IIFDA’s classMay 30, 2018in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia
- Medical device recall Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of… Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET cardiac gating examinations may experience a waveform sampling… Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MindFrame Capture LP Revascularization Devices: Product Numbers: (a) There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 23, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 23, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT… Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT… Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT… Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT… Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Thoratec HeartMate 3 LVAS Implant Kit Reports of outflow graft twist occlusions. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 23, 2018in FDA’s Enforcement Report35 statesnamed in where it went PublishedMay 23, 2018ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035”, 150 cm Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014”, 150 cm Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood Beckman Coulter has received customer complaints of lowered minimum inhibitory concentration (MIC) for antimicrobial agents Cefaclor (Ctr) and Penicillin (P)… Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Persona Stemmed Tibial Provisional Size H Left There is a potential for intermittent cracks in the raw material batch used to produce the affected products. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Persona Stemmed Tibial Provisional Size H Right There is a potential for intermittent cracks in the raw material batch used to produce the affected products. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Persona Cemented Tibial SZ PLT Size H Left There is a potential for intermittent cracks in the raw material batch used to produce the affected products. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Persona Cemented Tibial SZ PLT Size H Right There is a potential for intermittent cracks in the raw material batch used to produce the affected products. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro… The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use… The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended… The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Infinity Acute Care System (lACS) Monitoring Solution Software anomaly resulting in the loss of patient settings and stored patient data. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endo GIA” Auto Suture” Universal Articulating Loading Unit 30mm- 2.0mm ( Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endo GIA” Auto Suture” Universal Articulating Loading Unit 30mm - 2.5mm ( Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endo GIA” Auto Suture” Universal Articulating Loading Unit 30mm - 3.5mm ( Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endo GIA” Auto Suture” Universal Articulating Loading Unit 45mm - 2.5mm( Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endo GIA” Auto Suture” Universal Articulating Loading Unit 45mm- 3.5mm( Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endo GIA” Auto Suture” Universal Articulating Loading Unit 60mm -2.5mm ( Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endo GIA” Auto Suture” Universal Articulating Loading Unit 60mm - 3.5mm ( Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endo GIA” 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple” Technology( Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endo GIA” 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple” Technology( Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endo GIA” 45mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple” Technology( Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien” Best Practices” Procedure Kits containing Auto Suture” Endo GIA” Devices Product Usage: The Endo… Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BOX KIT1095V KIT OBESITAS (Item Code KIT1095V) Product Usage: The Endo GIA universal and Endo GIA universal… Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall (1) BOX 01KBAR006116V PROC BYPASS 01KBAR0061(Item Code 01KBAR006116V PROC BYPAS) Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BOX1073076GASB1 BBR GASTRIC BYPASS S(Item Code BOX1073076GASB1 BBR GASTRIC BYPASS S) Product Usage: The Endo… Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall (1) BOX BOX1073180 APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180) Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall (1)BOX HEMIGX1 ZESTAW DO HEMICOLECTOMII (Item Number HEMIGX1 ZESTAW DO HEMICOLECTOMII) Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall KIT00486R OBESIDAD D Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BOX KIT00713 KIT BY PASS Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two,… Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BOX KIT00714 KIT SLEEVE Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two,… Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass 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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