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 6, 2026.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall Maquet Getinge BO-TOP 28903 Adult ECC Pack Material: -709000093R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge- BEQ-T 53500 Evanston Rotaflow Pack Material:709000215R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material:-709000266R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge- BEQ-T 9411 Lurie Children’s 1/4 ADAPT Material:709000485R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall King LTS-D Kit Size 1 Size 0 products were incorrectly packaged and labeled as a size 1 products. Class IIFDA’s classJun 5, 2019in FDA’s Enforcement Report11 statesnamed in where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Iowa, Indiana, Maryland, Mississippi, North Carolina, Pennsylvania, Texas and Wisconsin
- Medical device recall RUSCH LASERTUBE (Rubber), Order No. : 102004-000040 The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges. Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RUSCH LASERTUBE (Rubber), Order No. : 102004-000050 The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges. Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RUSCH LASERTUBE (Rubber), Order No. : 102004-000060 The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges. Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RUSCH LASERTUBE (Rubber), Order No. : 102004-000070 The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges. Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RUSCH LASERTUBE (Rubber), Order No. : 102004-000080 The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges. Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive force applied… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement Report49 statesnamed in where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereAlabama, 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, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Opteform Allograft Disc, 30mm 3mm, 2cc The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereFlorida, Oklahoma and Virginia
- Medical device recall Opteform Allograft Disc, 45mm x 5mm, 8cc The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereFlorida, Oklahoma and Virginia
- Medical device recall Opteform Allograft Disc, 90mm x 5mm, 22cc The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereFlorida, Oklahoma and Virginia
- Medical device recall Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is… Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to… Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMay 29, 2019ClassClass IStatusTerminatedWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a… Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic… Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a… Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic… Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used… Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic… Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr 10102 10-102 CSF Drainage… The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: The MoniTorr ICP… The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1 INS-9020SP1 LIMITORR VOLUME… The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Michigan, Ohio and Texas named
- Medical device recall ICSI MICROPIPETTE CooperSurgical ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For… Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the… Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report11 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Georgia, Iowa, Missouri, New Jersey, New York, South Carolina, Tennessee and Texas
- Medical device recall Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr 003500 G14916 Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent… Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168… Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent… Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lipid Panel test strips Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lipid Panel test strips (as a component of smart bundles) Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being di P832… Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CHOL+HDL+GLU test strips Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Thio Med w/Dex, Hem, Vit K Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Thio Med w/Dex, Hemin, Vit K Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Thio Med w/Dex, Hem, Vit K Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Thio Med w/Dex, Hem, Vit, K Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Pin hole package failures compromising sterility of product Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall UniCel DxH 800 Coulter Cellular Analysis System Complaints received of sporadic erroneously elevated platelet results without flags or system messages. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 29, 2019ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall UniCel DxH 600 Coulter Cellular Analysis System Complaints received of sporadic erroneously elevated platelet results without flags or system messages. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 29, 2019ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall UniCel DxH 900 Coulter Cellular Analysis System Complaints received of sporadic erroneously elevated platelet results without flags or system messages. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 29, 2019ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor… The sensor’s look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the… There is a potential the joint in the suspension of the device is insufficiently assembled. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 29, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is… Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide, and California and Florida named
- Medical device recall Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage:… Dental adaptor does not conform to specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide, and Ohio named
- Medical device recall AURIGA XL 4007 BRAZIL SYSTEM Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low… Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Auriga XL 4007 Laser System and the… Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low… Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall AURIGA XL 4007 GENERAL - DEMO SYSTEM UPN: M0068FS4007GD0 Product Usage: The Auriga XL 4007 Laser System and… Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low… Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall AURIGA XL 4007 GENERAL - ZERO COST SYSTE UPN: FS4007GZ0 Product Usage: The Auriga XL 4007 Laser System and… Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low… Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30… Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low… Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 29, 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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