Medical Device Recalls

8,689 medical device recalls from federal enforcement feeds.

Showing 4,251–4,300 of 8,689

• Medical Device Recall · March 19, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296

  It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

  Class II

• Medical Device Recall · March 19, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A

  It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

  Class II

• Medical Device Recall · March 19, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438

  It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

  Class II

• Medical Device Recall · March 19, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits, labeled as: HAND, REF DYNJ902002J

  It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

  Class II

• Medical Device Recall · March 19, 2025

  Siemens Healthcare Diagnostics Inc

  epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 &

  The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.

  Class II

• Medical Device Recall · March 19, 2025

  Spectrum Medical Ltd.

  Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is int

  Medical device software marketed without FDA clearance .

  Class II

• Medical Device Recall · March 19, 2025

  Avanos Medical, Inc.

  Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F

  Lack of sterility assurance for closed suction catheter systems

  Class I

• Medical Device Recall · March 19, 2025

  Avanos Medical, Inc.

  Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE

  Lack of sterility assurance for closed suction catheter systems

  Class I

• Medical Device Recall · March 19, 2025

  Avanos Medical, Inc.

  Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow

  Lack of sterility assurance for closed suction catheter systems

  Class I

• Medical Device Recall · March 19, 2025

  Siemens Healthcare Diagnostics Inc

  epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4

  The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.

  Class II

• Medical Device Recall · March 19, 2025

  Avanos Medical, Inc.

  Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow

  Lack of sterility assurance for closed suction catheter systems

  Class I

• Medical Device Recall · March 19, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A.

  It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

  Class II

• Medical Device Recall · March 19, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792

  It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

  Class II

• Medical Device Recall · March 19, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL TRAY, REF DYNDC1311C; 4) SENSITIVE SKIN WEEKLY VAD, REF DYND

  It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

  Class II

• Medical Device Recall · March 19, 2025

  Avanos Medical, Inc.

  Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE Component: N

  Lack of sterility assurance for closed suction catheter systems

  Class I

• Medical Device Recall · March 19, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K

  It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

  Class II

• Medical Device Recall · March 19, 2025

  Spectrum Medical Ltd.

  Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VISION / LIVE VUE is a software-only d

  Medical device software marketed without FDA clearance .

  Class II

• Medical Device Recall · March 19, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535

  It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

  Class II

• Medical Device Recall · March 19, 2025

  Avanos Medical, Inc.

  Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapte

  Lack of sterility assurance for closed suction catheter systems

  Class I

• Medical Device Recall · March 19, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Sterile Water, USP, 100mL, REF RDI30295

  It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

  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

  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

  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-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: 08H67-03 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-2300. Item numbers: DCF-E2310D3/1¿(German/English dual language), DCF-E2310E3/1¿(German/French dual language), DCF-E2310F3/1¿ (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

  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

  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

  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

  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

  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 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

  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 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

  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 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 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

  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 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: 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

  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

  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 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 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 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 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