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 SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product Usage: The SKINFUSE Rescue Calming… Cosmetic Kit was packaged with a mislabel medical product. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units Product shelf life may be shorter than that indicated on the label. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 18, 2019ClassClass IIStatusOngoingWhereNationwide, and Illinois, Indiana, Maryland, Mississippi, New Jersey and Tennessee named
- Medical device recall P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement Report34 statesnamed in where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall VNS Therapy Program GMDN: 44077 This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic… Class IIFDA’s classDec 18, 2019in FDA’s Enforcement Report47 statesnamed in where it went PublishedDec 18, 2019ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Radiofrequency Grounding Pad Affected lots were manufactured with the protective release liner in an incorrect orientation. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Healix Knotless ADV BR 4.75 Suture Anchor Specific product codes and lots of the Mitek HEALIX ADVANCE” Knotless Anchors were manufactured with BIOCRYL” Biocomposite Material instead of BIOCRYL RAPIDE¿… Class IIFDA’s classDec 18, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall Healix Knotless ADV BR 5.5 Suture Anchor Specific product codes and lots of the Mitek HEALIX ADVANCE” Knotless Anchors were manufactured with BIOCRYL” Biocomposite Material instead of BIOCRYL RAPIDE¿… Class IIFDA’s classDec 18, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is… During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Massachusetts, Maryland, Minnesota, New Jersey, New York, Tennessee and Texas named
- Medical device recall Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is… During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Massachusetts, Maryland, Minnesota, New Jersey, New York, Tennessee and Texas named
- Medical device recall Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus… Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous Border Area setting, (1.0 1.00) instead of (0.90 1.10). Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Monaco Radiation Treatment Planning System (RTP) System Monaco is using the incorrect energy when optimizing and calculating dose. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 18, 2019ClassClass IIStatusOngoingWhereIowa, Indiana, New York, Ohio, Texas and Wisconsin
- Medical device recall Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the… Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide, and California and Georgia named
- Medical device recall iTotal CR Knee Replacement System Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall BOND Polymer Refine Detection Kit BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some… Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS). Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cognision, Subject Kit (Clinical Grade) Product has the potential to be contaminated with Burkholderia cepacia (B. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MRIdian Linac Radiation Therapy System Issue with transferring treatment regiment from one system to another. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Michigan, Missouri, New York and Wisconsin
- Medical device recall Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline… Sterile barrier system may be compromised Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereMaine, Nevada, New York, Ohio, Pennsylvania, Texas and Virginia
- Medical device recall Synchromed II programmable pump There is a potential for the presence of a foreign particle inside the pump motor assembly which could interfere with the motor gear rotation and lead to a… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 11, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Giraffe OmniBed infant warmer Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 11, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Giraffe OmniBed Carestation Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 11, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 11, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Giraffe Incubator infant warmer Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 11, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain full y engaged with the transfer carriage and result in the… Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm… One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick… There is a potential for the cuff to leak air leading to a loss of vascular occlusion. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Hawaii, Iowa, Idaho, Indiana, Kansas, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Virginia, Wisconsin, West Virginia and Wyoming named
- Medical device recall Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect… There is a potential for the cuff to leak air leading to a loss of vascular occlusion. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Hawaii, Iowa, Idaho, Indiana, Kansas, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Virginia, Wisconsin, West Virginia and Wyoming named
- Medical device recall Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but… Class IIFDA’s classDec 11, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereCalifornia, Florida, Indiana, Minnesota, Missouri, New York and Utah
- Medical device recall Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but… Class IIFDA’s classDec 11, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereCalifornia, Florida, Indiana, Minnesota, Missouri, New York and Utah
- Medical device recall EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have resulted in a non-compliance with the IEC 60601-1-2 standard. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereKentucky, Missouri, New York, Ohio and Pennsylvania
- Medical device recall EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have resulted in a non-compliance with the IEC 60601-1-2 standard. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereKentucky, Missouri, New York, Ohio and Pennsylvania
- Medical device recall XEN Gel Stent Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be present on the injector needle. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PANTERA Proximal Humerus Fracture Plate System Potential suture clip breaking during a humerus fixation surgery. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereArkansas, Florida and Puerto Rico
- Medical device recall Quantam 2000 Electrosurgical Generator Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a… Class IIFDA’s classDec 11, 2019in FDA’s Enforcement Report28 statesnamed in where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maine, Montana, North Dakota, New Jersey, Nevada, New York, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia
- Medical device recall Quantam 2000 Electrosurgical Generator Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a… Class IIFDA’s classDec 11, 2019in FDA’s Enforcement Report28 statesnamed in where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maine, Montana, North Dakota, New Jersey, Nevada, New York, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia
- Medical device recall Quantam 2000 Electrosurgical Generator Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a… Class IIFDA’s classDec 11, 2019in FDA’s Enforcement Report28 statesnamed in where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maine, Montana, North Dakota, New Jersey, Nevada, New York, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia
- Medical device recall Proximal Humerus Plate, 8 holes, Right Right Proximal Humerus Plates. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Massachusetts, New York, Ohio, Pennsylvania, Rhode Island, Texas, Virginia and Washington named
- Medical device recall Eagle 3000 Sterilizer, small steam sterilizer Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for the 3000 Small Sterilizers. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, 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 and West Virginia named
- Medical device recall TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain. Device was shipped without a Unique Device Identification (UDI) label. Class IIIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedDec 11, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Minnesota, North Carolina, New Jersey, New Mexico, New York, Oregon and Wisconsin named
- Medical device recall TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of… Device was shipped without a Unique Device Identification (UDI) label and a separate label identifies the power pack as CE Marked when the device has not yet… Class IIIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedDec 11, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Minnesota, North Carolina, New Jersey, New Mexico, New York, Oregon and Wisconsin named
- Medical device recall HeartStart XL+ Defibrillator/Monitor Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for use state. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx,… The product may be counterfeit and could have microbial issues. Class IIFDA’s classDec 11, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2019ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Rocket KCH Fetal Bladder Drainage Catheter A complaint was received regarding kinking of the device prior to use. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per… Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Georgia, Idaho, Illinois, Indiana, Kansas, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Nevada, Ohio, Oregon, South Carolina, Tennessee, Texas, Utah, Washington, Wisconsin and Wyoming named
- Medical device recall Stryker X-Change Medial Wall Mesh Small Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015) Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage:… When the UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II dispense probe is slightly bent, there is a potential for cell carryover from the… Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ASI 2.0 Calcar Trimmer Shaft for Use with Biomet¿ Rasp The potential that the end of the shaft could fail to effectively mate with the broach with the Calcar Planar Shaft instrument, part number 110032331. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement Report11 statesnamed in where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Indiana, Kentucky, Louisiana, Minnesota, New Jersey, New York, Ohio and Texas
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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