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 BD Synapsys Laboratory Solutions BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record. Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Missouri, Ohio and Tennessee named
- Medical device recall MultiDiagnost-Eleva The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user. Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all… The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user. Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Omnidiagnost Classic The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user. Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MultiDiagnost Eleva w/ Flat Detector The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user. Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall URODiagnost Eleva The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user. Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Randox Blood Gas Control Level 2 -Model BG5002 An error in the assignment of the control range pH in Blood Gas Control Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportWest Virginiathe one state its words name PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereWest Virginia
- Medical device recall Sunset Compressor Nebulizer The product was designed for 120V usage and is being used in South Africa with 220V. Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Vacuum Unit for CATSmart Vacuum Pump The optional Vacuum Unit may stop working and display the failure message “Failure vacuum unit” during use. Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Hawaii, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas and Virginia named
- Medical device recall Integrated ECG cable with 3-lead leadwires labeled as the following: 1 The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduct 25% of the defibrillation energy away from the patient. Class IIIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedApr 3, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Kansas, Massachusetts, Maine, New Jersey, New Mexico, New York and Texas named
- Medical device recall Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications… Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments… Class IIFDA’s classApr 3, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereFlorida, Massachusetts, South Carolina and Virginia
- Medical device recall Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications… Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments… Class IIFDA’s classApr 3, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereFlorida, Massachusetts, South Carolina and Virginia
- Medical device recall Paltop 1.25 Hex Drivers, Long Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments… Class IIFDA’s classApr 3, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereFlorida, Massachusetts, South Carolina and Virginia
- Medical device recall Paltop 1.25 Hex Drivers, Short Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments… Class IIFDA’s classApr 3, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereFlorida, Massachusetts, South Carolina and Virginia
- Medical device recall Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The… Rare isolates of Enterobacteriaceae may generate a susceptible meropenem Minimum Inhibitory Concentration (MIC) using the affected device and a resistant… Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, District of Columbia, Georgia, Iowa, Illinois, Maryland, Missouri, New York, Pennsylvania, Tennessee, Texas, Virginia and Washington named
- Medical device recall BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm Certain lots are missing a protective sheath component over the silicone tip, which may result in the silicone tip breaking or detaching at the metal tube… Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Louisiana, Maryland, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Texas, Utah, Virginia and Washington named
- Medical device recall Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor Lithium-ion Rechargeable Batteries for the Philips MX4O Wearable Monitor may have a manufacturing defect that may affect the operation of the monitor Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, Indiana, Michigan, North Carolina, North Dakota, New Mexico, Oregon, Tennessee, Texas and Utah named
- Medical device recall Laparotomy Sponge with the following product description and Potential lack of sterility assurance Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming named
- Medical device recall Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein… The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury. Class IIIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 3, 2019ClassClass IIIStatusOngoingWhereNo state named
- Medical device recall ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which… Class IIFDA’s classApr 3, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereCalifornia, Georgia, North Carolina, New York, Pennsylvania, Texas and Wisconsin
- Medical device recall ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60” Tubing,… Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which… Class IIFDA’s classApr 3, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereCalifornia, Georgia, North Carolina, New York, Pennsylvania, Texas and Wisconsin
- Medical device recall ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60” Tubing,… Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which… Class IIFDA’s classApr 3, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereCalifornia, Georgia, North Carolina, New York, Pennsylvania, Texas and Wisconsin
- Medical device recall On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated… On-X Valve was mislabeled with the incorrect serial number. Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall Dimension Vista 500, Analyzer, chemistry When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension Vista Triglyceride assay, patient and QC triglyceride results… Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista 1500, Analyzer, chemistry When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension Vista Triglyceride assay, patient and QC triglyceride results… Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox… The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedMar 27, 2019ClassClass IIStatusOngoingWhereCalifornia, Maine, Michigan and West Virginia
- Medical device recall Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox… The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedMar 27, 2019ClassClass IIStatusOngoingWhereCalifornia, Maine, Michigan and West Virginia
- Medical device recall Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox… The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedMar 27, 2019ClassClass IIStatusOngoingWhereCalifornia, Maine, Michigan and West Virginia
- Medical device recall aap Implante AG, Lambotte chisel, 20 mm There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Texas named
- Medical device recall Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or… Potential for the sterile packaging to be compromised Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Updates to the Instructions for Use. Class IIIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach Updates to the Instructions for Use. Class IIIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach Updates to the Instructions for Use. Class IIIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach Updates to the Instructions for Use. Class IIIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach Updates to the Instructions for Use. Class IIIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach Updates to the Instructions for Use. Class IIIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMar 27, 2019ClassClass IIStatusOngoingWhereNationwide, and Iowa, Illinois, New York and South Carolina named
- Medical device recall smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM Complaints were received indicating that the outer label incorrectly identified the product as size “1” instead of “-1”. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Indiana, Missouri, North Carolina and Tennessee
- Medical device recall smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM Complaints were received indicating that the outer label incorrectly identified the product as size “1” instead of “-1”. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Indiana, Missouri, North Carolina and Tennessee
- Medical device recall CTL Medical Hex Driver, 1/4” Square QC, 4.0 Ratcheting the anti-toggle ring of the hex driver may separate from the driver shaft. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CTL Medical Hex Driver MIS, 1/4” Square QC, 4.0 Ratcheting the anti-toggle ring of the hex driver may separate from the driver shaft. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Gentrix Surgical Matrix Thick, 30 x 40cm The devices were released from a lot for which one sample failed to meet the company’ s tensile strength specification for lot release. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall Gentrix Surgical Matrix Thick, 20 x 30cm The devices were released from a lot for which one sample failed to meet the company’ s tensile strength specification for lot release. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Class IIIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 27, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Ohio named
- Medical device recall Forceps Blue, disposable, sterile, 100 eaches per sales unit An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMar 27, 2019ClassClass IIStatusOngoingWhereNationwide, and Illinois, Michigan, Pennsylvania and Wisconsin named
- Medical device recall Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMar 27, 2019ClassClass IIStatusOngoingWhereNationwide, and Illinois, Michigan, Pennsylvania and Wisconsin named
- Medical device recall Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMar 27, 2019ClassClass IIStatusOngoingWhereNationwide, and Illinois, Michigan, Pennsylvania and Wisconsin named
- Medical device recall FilterFlow Suction Handle CH24, 20 eaches per sales unit An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMar 27, 2019ClassClass IIStatusOngoingWhereNationwide, and Illinois, Michigan, Pennsylvania and Wisconsin 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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