Medical devices, 2023: every recall, from FDA

Medical device recall 3M Attest Super Rapid Readout Steam Challenge Pack Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest… Class IIFDA’s classOct 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 4, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest… Class IIFDA’s classOct 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 4, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20… Product is labeled with incorrect offset. Class IIFDA’s classOct 4, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 4, 2023ClassClass IIStatusOngoingWhereAlabama, New Jersey and Nevada

Medical device recall Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous,… Sterile barrier might be damaged compromising the sterility of the device. Class IIFDA’s classOct 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 4, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate… The sterile blister packaging may be damaged, and sterility may be compromised Class IIFDA’s classOct 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 4, 2023ClassClass IIStatusOngoingWhereNationwide, and Virginia named

Medical device recall B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an… The sterile blister packaging may be damaged, and sterility may be compromised Class IIFDA’s classOct 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 4, 2023ClassClass IIStatusOngoingWhereNationwide, and Virginia named

Medical device recall Cinchlock SS Knotless Anchor Inserter Expired Product distributed Class IIFDA’s classOct 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 4, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Georgia, Illinois, Kentucky, North Carolina, New Mexico, New York, Tennessee and Utah named

Medical device recall BD Pyxis MedBank MedPass Software After dispensing a timed dose medication for a patient, the automated dispensing cabinet software may continue to show the already dispensed medication dose is… Class IIFDA’s classOct 4, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 4, 2023ClassClass IIStatusOngoingWhereFlorida, Kansas and Michigan

Medical device recall Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x,… Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System software listed below… Class IIFDA’s classOct 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedOct 4, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Missouri, Mississippi, Montana, Nebraska, New Hampshire, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named

Medical device recall Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board… FDA Class I, its most serious class Class IFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 27, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named

Medical device recall Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board… FDA Class I, its most serious class Class IFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 27, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named

Medical device recall Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board… FDA Class I, its most serious class Class IFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 27, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named

Medical device recall Hamilton-MR1 Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board… FDA Class I, its most serious class Class IFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 27, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named

Medical device recall Hamilton C1/T1/MR1 Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board… FDA Class I, its most serious class Class IFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 27, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named

Medical device recall Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board… FDA Class I, its most serious class Class IFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 27, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named

Medical device recall Five S 5 3x65 Flexible intubation endoscopes sterility assurance can not be confirmed. Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedSep 27, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall Arrow ErgoPack Pressure Injectable One-Lumen PICC This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall Membrane Changer Single-Use During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact… Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall APK2 Pressure-Sensing Wheelchair Cushions Defective battery pack in wheelchair cushions can overheat resulting in property damage and one possible injury. Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall SofTech Pressure-Sensing Wheelchair Cushions Defective battery pack in wheelchair cushions can overheat resulting in property damage and one possible injury. Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall MEDLINE STERILE IRIS SCISSORS CVD/STD 4.5” Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement… Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the… Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user… Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the… Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone… Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the… Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the… Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the… Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the… Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the… Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may… Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report26 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Texas, Utah, Virginia and Washington

Medical device recall DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may… Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report26 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Texas, Utah, Virginia and Washington

Medical device recall DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3 Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may… Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report26 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Texas, Utah, Virginia and Washington

Medical device recall DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may… Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report26 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Texas, Utah, Virginia and Washington

Medical device recall DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may… Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report26 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Texas, Utah, Virginia and Washington

Medical device recall Patient Information Center iX with Software Version Number 4.x in the following Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driver Error-with a blank screen and subsequently require a manual… Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall Liquid Assayed Chemistry Control Premium Plus Level 3 there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report6 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereGeorgia, Ohio, Oregon, Pennsylvania, Texas and Virginia

Medical device recall TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to… Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusTerminatedWhereOhio, South Carolina and Virginia

Medical device recall TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into the body to… Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusTerminatedWhereOhio, South Carolina and Virginia

Medical device recall TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural… Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusTerminatedWhereOhio, South Carolina and Virginia

Medical device recall Prucka 3 Amplifiers A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevated temperatures and fail, then power off and… Class IIFDA’s classSep 27, 2023in FDA’s Enforcement Report17 statesnamed in where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia and Wisconsin

Medical device recall Gallant VR Implantable Cardioverter Defibrillator: VR ICD Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices… Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices… Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50,… Internal testing on returned product from this lot confirmed that some PDS” II (polydioxanone) Sutures from this lot did not meet tensile strength requirement. Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05,… Internal testing on returned product from this lot confirmed that some PDS” II (polydioxanone) Sutures from this lot did not meet tensile strength requirement. Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall Omnipod 5 Automated Insulin Delivery System An error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone control users from controlling the Omnipod 5… Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall MINISCAV (tm) Vacuum Pump Inadequate documentation of acceptance activity Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportOhiothe one state its words name PublishedSep 27, 2023ClassClass IIStatusOngoingWhereOhio

Medical device recall COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs. Due to plastic defects, the pipette aspiration capability potentially doesn’t meet the expected tolerance Class IIFDA’s classSep 27, 2023in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedSep 27, 2023ClassClass IIStatusOngoingWhereCalifornia

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