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 7, 2026.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall Edwards Lifesciences Swan Ganz Thermodilution Catheter These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 6, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 6, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Vial2BAG DC 13mm Adverse events have been reported with the use of oxytocin in conjunction with the product in pregnant women. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 6, 2019in FDA’s Enforcement ReportMissourithe one state its words name PublishedFeb 6, 2019ClassClass IStatusTerminatedWhereMissouri
- Medical device recall Vial2BAG Transfer Device Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 6, 2019in FDA’s Enforcement ReportMissourithe one state its words name PublishedFeb 6, 2019ClassClass IStatusTerminatedWhereMissouri
- Medical device recall Vial2BAG DC 20mm: 1) Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 6, 2019in FDA’s Enforcement ReportMissourithe one state its words name PublishedFeb 6, 2019ClassClass IStatusTerminatedWhereMissouri
- Medical device recall COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) were mislabeled as Captura Serrated Large Forcep-No Spike… Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) were mislabeled as Captura Serrated Large Forcep-No Spike… Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style Product is labeled with “CE”, but is not yet approved in the European Union. Class IIIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 6, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Florida, Illinois and Washington named
- Medical device recall Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell… Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing. Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The Haemonetics Cell Saver… Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing. Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Atellica IM 1300 Analyzer Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atellica¿ CH… Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica… Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atellica¿ CH… Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atellica CH 930 Analyzer Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atellica¿ CH… Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atellica Sample Handler Prime Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atellica¿ CH… Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay… Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 module. Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RESERVOIR “Y” ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with… Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 6, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated… Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 6, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Increased temperature in the probe-head surface with LOGIQ P6 Model BT07 and BT09 scanners when used in specific types of scans and with specific probes. Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Alinity i Processing Module, (a) Abbott has identified an issue with the Alinity i Gear Pump Assembly (part number A 30108552 01) resulting in foaming/bubbling out of the bottle reservoir for… Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC This recall has been initiated due to a change in packaging and sterilization method to address potential risks of compromised sterilization presented by the… Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Indiana, Louisiana, Michigan, Mississippi, Nevada, Texas and West Virginia
- Medical device recall 3M(TM) Surgical Clipper by Remington(R) 3M has recently received reports involving the 3MTM Surgical Clipper by Remington¿, Model 9602, overheating in mobile/field EMS situations while charging from… Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall VentStar Basic 180 Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 30, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedJan 30, 2019ClassClass IStatusTerminatedWhereAlabama, California, Colorado, Connecticut, Florida, Kentucky, Michigan, New Jersey, Ohio, Pennsylvania, South Carolina and Texas
- Medical device recall VentStar Basic 250 Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 30, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedJan 30, 2019ClassClass IStatusTerminatedWhereAlabama, California, Colorado, Connecticut, Florida, Kentucky, Michigan, New Jersey, Ohio, Pennsylvania, South Carolina and Texas
- Medical device recall VentStar Basic (P) 180 Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 30, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedJan 30, 2019ClassClass IStatusTerminatedWhereAlabama, California, Colorado, Connecticut, Florida, Kentucky, Michigan, New Jersey, Ohio, Pennsylvania, South Carolina and Texas
- Medical device recall VentStar Basic (P) 250 Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 30, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedJan 30, 2019ClassClass IStatusTerminatedWhereAlabama, California, Colorado, Connecticut, Florida, Kentucky, Michigan, New Jersey, Ohio, Pennsylvania, South Carolina and Texas
- Medical device recall VentStar Watertrap (P) 180 Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 30, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedJan 30, 2019ClassClass IStatusTerminatedWhereAlabama, California, Colorado, Connecticut, Florida, Kentucky, Michigan, New Jersey, Ohio, Pennsylvania, South Carolina and Texas
- Medical device recall VentStar Anesthesia WT(P) 180 Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 30, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedJan 30, 2019ClassClass IStatusTerminatedWhereAlabama, California, Colorado, Connecticut, Florida, Kentucky, Michigan, New Jersey, Ohio, Pennsylvania, South Carolina and Texas
- Medical device recall ID Circuit Watertrap (P) 180 Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 30, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedJan 30, 2019ClassClass IStatusTerminatedWhereAlabama, California, Colorado, Connecticut, Florida, Kentucky, Michigan, New Jersey, Ohio, Pennsylvania, South Carolina and Texas
- Medical device recall ID Circuit Basic 250 Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 30, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedJan 30, 2019ClassClass IStatusTerminatedWhereAlabama, California, Colorado, Connecticut, Florida, Kentucky, Michigan, New Jersey, Ohio, Pennsylvania, South Carolina and Texas
- Medical device recall ID Circuit Basic 180 Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 30, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedJan 30, 2019ClassClass IStatusTerminatedWhereAlabama, California, Colorado, Connecticut, Florida, Kentucky, Michigan, New Jersey, Ohio, Pennsylvania, South Carolina and Texas
- Medical device recall Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 The Percutaneous Surgical System with 5mm attachments is… There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. Class IIFDA’s classJan 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 30, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3 The Percutaneous Surgical System with 5mm attachments is… There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. Class IIFDA’s classJan 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 30, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 16600 / Fetzer Surgical Luikart Simpson OB Forceps14” The firm had a report of doctors being unable to pull the obstetric forceps apart. Class IIFDA’s classJan 30, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 30, 2019ClassClass IIStatusTerminatedWhereIllinois and Virginia
- Medical device recall 12002 / Boss Instruments Ltd The firm had a report of doctors being unable to pull the obstetric forceps apart. Class IIFDA’s classJan 30, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 30, 2019ClassClass IIStatusTerminatedWhereIllinois and Virginia
- Medical device recall 16600 / Fetzer Surgical De Lee Obstetric Forceps, 11” The firm had a report of doctors being unable to pull the obstetric forceps apart. Class IIFDA’s classJan 30, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 30, 2019ClassClass IIStatusTerminatedWhereIllinois and Virginia
- Medical device recall 12002 / Boss Instruments Simpson OB Forceps, short The firm had a report of doctors being unable to pull the obstetric forceps apart. Class IIFDA’s classJan 30, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 30, 2019ClassClass IIStatusTerminatedWhereIllinois and Virginia
- Medical device recall Heating Profile PRISMAFLO II S blood return warmer for Prismaflex PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin… Class IIFDA’s classJan 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 30, 2019ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall Heating Profile PRISMAFLO II S blood return warmer for Prismaflex PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin… Class IIFDA’s classJan 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 30, 2019ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall Heating Profile PRISMAFLO II blood return warmer for Prismaflex PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin… Class IIFDA’s classJan 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 30, 2019ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter Stryker s Sustainability Solutions division (SSS) has received an increase in reports indicating that an EEPROM chip error code may occur when Reprocessed 2515… Class IIFDA’s classJan 30, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedJan 30, 2019ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Iowa, Kansas, Missouri and Washington
- Medical device recall Perfusion Pack 4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems, indicated for use in surgical procedures requiring extracorporeal support… Class IIFDA’s classJan 30, 2019in FDA’s Enforcement Report39 statesnamed in where it went PublishedJan 30, 2019ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The… There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PCS] dose calculation algorithm. Class IIFDA’s classJan 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 30, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for… The M220 optics may unintentionally drop into the surgical field, risking contact with the patient. Class IIFDA’s classJan 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 30, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2… The lidstock states the incorrect priming volume and flow rates. Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida named
- Medical device recall Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including… Potentially lead to anchor breakage during insertion, Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedJan 23, 2019ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and Enteral Connector,… The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feeding tube as labeled. Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportTennesseethe one state its words name PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall Visions PV .035 Digital IVUS Catheter Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the… Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Visions PV .035 Digital IVUS Catheter Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the… Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile Dual Mobility System is… The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records. Class IIFDA’s classJan 23, 2019in FDA’s Enforcement Report8 statesnamed in where it went PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereArizona, Florida, Georgia, Louisiana, Michigan, Minnesota, Texas and Washington
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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