Medical Device Recalls

7,959 medical device recalls from federal enforcement feeds.

Showing 3,551–3,600 of 7,959

• Medical Device Recall · March 18, 2025

  Abbott Laboratories

  Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No

  When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

  Class II

• Medical Device Recall · March 18, 2025

  Defibtech, LLC

  Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language)

  It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).

  Class II

• Medical Device Recall · March 18, 2025

  Smith & Nephew, Inc.

  META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690

  Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.

  Class II

• Medical Device Recall · March 18, 2025

  Abbott Laboratories

  Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No

  When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

  Class II

• Medical Device Recall · March 18, 2025

  Defibtech, LLC

  Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)

  It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).

  Class II

• Medical Device Recall · March 18, 2025

  Defibtech, LLC

  Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)

  It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).

  Class II

• Medical Device Recall · March 18, 2025

  Abbott Laboratories

  Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No

  When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

  Class II

• Medical Device Recall · March 18, 2025

  Abbott Laboratories

  Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Description: CELL-DYN Ruby

  When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

  Class II

• Medical Device Recall · March 17, 2025

  Abbott

  Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080

  Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.

  Class II

• Medical Device Recall · March 17, 2025

  Abbott

  Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080

  Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.

  Class II

• Medical Device Recall · March 17, 2025

  Beckman Coulter Inc.

  DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3 The Beckman Coulter DxC

  The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results.

  Class II

• Medical Device Recall · March 14, 2025

  ESAOTE S.P.A.

  Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038

  A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable.

  Class II

• Medical Device Recall · March 14, 2025

  Merit Medical Systems, Inc.

  Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly

  Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

  Class II

• Medical Device Recall · March 14, 2025

  Pro-Med Instruments Gmbh

  DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)

  Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.

  Class II

• Medical Device Recall · March 14, 2025

  Merit Medical Systems, Inc.

  Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly

  Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

  Class II

• Medical Device Recall · March 13, 2025

  INSTITUT GEORGES LOPEZ

  Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical device. Celsior is a clea

  The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.

  Class II

• Medical Device Recall · March 13, 2025

  Thoratec LLC

  HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System.

  Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow Wrench or No External Power alarms. If MPU losses power, System Controller can support the pump up to 15 minutes, and if not switched to rechargeable batteries, pump may lose power.

  Class I

• Medical Device Recall · March 12, 2025

  Draeger, Inc.

  Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between

  The potential for cracks forming in the breathing circuit hose.

  Class I

• Medical Device Recall · March 12, 2025

  Qiagen Sciences LLC

  Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a

  Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.

  Class II

• Medical Device Recall · March 12, 2025

  Draeger, Inc.

  Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Version: Not applicable Product Description: Accessory for conducting medical

  The potential for cracks forming in the breathing circuit hose.

  Class I

• Medical Device Recall · March 12, 2025

  Draeger, Inc.

  Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 Software Version: Not applicable Product Description: Accessory for conducting medical

  The potential for cracks forming in the breathing circuit hose.

  Class I

• Medical Device Recall · March 12, 2025

  Draeger, Inc.

  Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 Software Version: Not applicable Product Description: Accessory for conducting medic

  The potential for cracks forming in the breathing circuit hose.

  Class I

• Medical Device Recall · March 12, 2025

  Draeger, Inc.

  Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an

  The potential for cracks forming in the breathing circuit hose.

  Class I

• Medical Device Recall · March 12, 2025

  Draeger, Inc.

  Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 Software Version: Not applicable Product Description: Accessory for conducting medical

  The potential for cracks forming in the breathing circuit hose.

  Class I

• Medical Device Recall · March 12, 2025

  Conavi Medical Inc.

  Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The No

  Due to manufacturing issues there is a potential for the catheter sheath to detach.

  Class I

• Medical Device Recall · March 12, 2025

  Draeger, Inc.

  Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Number: MP17103 Software Version: Not applicable Product Description: Accessory for conducting medica

  The potential for cracks forming in the breathing circuit hose.

  Class I

• Medical Device Recall · March 11, 2025

  Siemens Healthcare Diagnostics, Inc.

  Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.

  Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.

  Class II

• Medical Device Recall · March 11, 2025

  Bard Access Systems, Inc.

  BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 217

  Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

  Class I

• Medical Device Recall · March 11, 2025

  CareFusion 303, Inc.

  BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-1HM-1FM, 169-102; MINI 2FH, 138902-01; MINI 2FH, 169-104; MINI 2FM, 169-105;

  Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 destock transactions and 2 stock transactions, which results in doubling the bin quantity, which may result in a delay in access to desired medications and/or supplies, which may lead to temporary body function impairment.

  Class II

• Medical Device Recall · March 11, 2025

  CareFusion 303, Inc.

  BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (ADC) intended to securely store and dispense medications to a qua

  Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity to be recorded. This bug can also result in the CUBIE opening more times than needed for the transaction to be completed, which may result in a patient receiving more than the intended dose of medication.

  Class II

• Medical Device Recall · March 11, 2025

  CareFusion 303, Inc.

  BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 155140-01 BD PYXIS MEDBANK TWR MN CR-

  Due to a software issue, when attempting to restock the automated dispensing cabinet, user have received the banner message "Stocking window has passed, or item has been removed from purchase order. Please contact Pharmacy for assistance". When this occurs, the medication cannot be restocked and can potentially lead to delays in accessing medication for patients.

  Class II

• Medical Device Recall · March 10, 2025

  Maquet Cardiovascular, LLC

  Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).

  Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.

  Class II

• Medical Device Recall · March 10, 2025

  Medtronic Xomed, Inc.

  NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1; PATIEN

  Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.

  Class II

• Medical Device Recall · March 10, 2025

  Philips North America Llc

  Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.

  Potential for collimator to fall as a result of incorrect installation.

  Class II

• Medical Device Recall · March 10, 2025

  Philips North America Llc

  Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.

  Potential for collimator to fall as a result of incorrect installation.

  Class II

• Medical Device Recall · March 8, 2025

  Straumann USA LLC

  TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;

  The devices are missing the laser marked depth markings.

  Class II

• Medical Device Recall · March 7, 2025

  Ethicon Endo Surgery, LLC

  PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP

  Identified curing issues with the silicone during the needles manufacturing process.

  Class II

• Medical Device Recall · March 7, 2025

  Ethicon Endo Surgery, LLC

  ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH

  Identified curing issues with the silicone during the needles manufacturing process.

  Class II

• Medical Device Recall · March 7, 2025

  Ethicon Endo Surgery, LLC

  PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1

  Identified curing issues with the silicone during the needles manufacturing process.

  Class II

• Medical Device Recall · March 7, 2025

  Ethicon Endo Surgery, LLC

  PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM

  Identified curing issues with the silicone during the needles manufacturing process.

  Class II

• Medical Device Recall · March 6, 2025

  GE Medical Systems, LLC

  Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VGW), R3 Surgery for China (Model Number H45113VGSU), R3 PeriOP f

  The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.

  Class II

• Medical Device Recall · March 6, 2025

  Fisher Diagnostics

  Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.

  The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.

  Class II

• Medical Device Recall · March 6, 2025

  GE Medical Systems, LLC

  Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45335VFS, H45335VFSW), R3 Surgery for China, R3 PeriOP for Chin

  The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.

  Class II

• Medical Device Recall · March 6, 2025

  Fisher Diagnostics

  Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.

  The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.

  Class II

• Medical Device Recall · March 5, 2025

  Tornier S.A.S.

  stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

  Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.

  Class II

• Medical Device Recall · March 5, 2025

  Tornier S.A.S.

  stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

  Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.

  Class II

• Medical Device Recall · March 5, 2025

  Advanced Bionics, LLC

  HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607

  Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.

  Class II

• Medical Device Recall · March 5, 2025

  Tornier S.A.S.

  stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoul

  Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.

  Class II

• Medical Device Recall · March 5, 2025

  Tornier S.A.S.

  stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

  Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.

  Class II

• Medical Device Recall · March 5, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R

  Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

  Class II