Medical devices, 2019
Shortlist up to four to read them side by side.
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 5, 2026.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall VITROS chemistry Products Cl- Slides Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS chemistry Products K+ Slides Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument… There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Hawaii, Louisiana, Massachusetts, Missouri, North Carolina, New York and Oklahoma named
- Medical device recall Hitachi Scenaria Whole-body X-ray CT System There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and… Class IIFDA’s classNov 13, 2019in FDA’s Enforcement Report16 statesnamed in where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Iowa, Indiana, Maryland, Montana, North Carolina, New York, Ohio, Oklahoma, Puerto Rico, South Dakota, Tennessee, Texas and Wyoming
- Medical device recall Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportOhiothe one state its words name PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereOhio
- Medical device recall Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportOhiothe one state its words name PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereOhio
- Medical device recall StemPro¿ MSC SFM CTS” Component was not tested by the supplier for adventitious agents Class IIFDA’s classNov 13, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Kansas, Massachusetts, Maryland, Minnesota, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall CTSTM Essential 8 Medium Component was not tested by the supplier for adventitious agents Class IIFDA’s classNov 13, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Kansas, Massachusetts, Maryland, Minnesota, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Prismaflex Control Unit, software versions below 7.21 Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 13, 2019ClassClass IIStatusOngoingWhereNationwide, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Prismaflex Control Unit, software versions below 7.21 Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 13, 2019ClassClass IIStatusOngoingWhereNationwide, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Prismaflex Control Unit, software versions below 7.21 Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 13, 2019ClassClass IIStatusOngoingWhereNationwide, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Prismaflex Control Unit, software versions below 7.21 Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 13, 2019ClassClass IIStatusOngoingWhereNationwide, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Prismaflex Control Unit, software versions below 7.21 Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 13, 2019ClassClass IIStatusOngoingWhereNationwide, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer… Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedNov 13, 2019ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Idaho, Illinois, Kansas, Michigan, North Carolina, New Jersey, New Mexico, Pennsylvania, Texas and Virginia named
- Medical device recall Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox… The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Maine, New Jersey, Puerto Rico and West Virginia named
- Medical device recall Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid… The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Maine, New Jersey, Puerto Rico and West Virginia named
- Medical device recall MaxZero Extension Sets with Needle-less Connector BD has decided to initiate a voluntary recall due to a confirmed complaint trend for droplets of fluid separating from the sealed surface of the MaxZero… Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023 Power-Trialysis… A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereArkansas, Florida, Illinois, New Jersey, Texas and Wisconsin
- Medical device recall Hemo-Drop Blood Dispenser The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead… Class IIIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Manual Diff Dropper The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead… Class IIIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Argon Medical Devices Double Male LL Adapter The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall (1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Argon Medical Devices Plugs, Male/Female Luer Lock Plug The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Argon Medical Devices Hemostasis Valve, 7F-9F The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Argon Medical Devices Septishield II, 80 cm The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Argon Medical Devices AHD Luer Lock Cap The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SPIFE Alkaline Hemoglobin Kit Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. Class IIIFDA’s classNov 13, 2019in FDA’s Enforcement Report22 statesnamed in where it went PublishedNov 13, 2019ClassClass IIIStatusOngoingWhereArizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia, Washington and Wisconsin
- Medical device recall BF Humeral Stem, Various Sizes Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Trabecular Metal Reverse Shoulder System Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sidus Stem-Free Shoulder Humeral Head Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Coorad Morrey Total Elbow Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various Custom Devices Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NCB Proximal Lateral Tibia, “NCB-PT LAX PROX 3H TIBIA”, Various Sizes Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NCB PERIPROSTHETIC, “NCB PP PROX FEM PLATE”, Various sizes Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZPLP Fibular Plate Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TM Ankle and Ankle Talus L/R Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Periarticular Plates - Tibial Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PERIARTICULAR PLATES - FEMUR Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DIST LAT FEM LCK PLATE STERILE Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SM DIS VOL/DORS RAD LAT COL PLATE Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Universal Locking Plates Sterile Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Periarticulare Plates - Elbow, Humeral and Ulna Plates Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass 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.”
Your shortlist0 of 4
Add one more to compare.