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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 3641–3660 of 39,430 recalls

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, DSE, MDI Component: N/A

Avanos Medical, Inc.

Lack of sterility assurance for closed suction catheter systems

March 19, 2025 · DeviceView details →

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-Adapter Component: No

Avanos Medical, Inc.

Lack of sterility assurance for closed suction catheter systems

March 19, 2025 · DeviceView details →

Class IIOngoing

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

MEDLINE INDUSTRIES, LP - Northfield

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.

March 19, 2025 · DeviceView details →

Class IIOngoing

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 DYNDC3185; 5) NURSING SKILLS, REF EDUC05015A; 6) NURSING SUPPLY BAG, REF EDUC1024A.

MEDLINE INDUSTRIES, LP - Northfield

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.

March 19, 2025 · DeviceView details →

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 Component: N/A

Avanos Medical, Inc.

Lack of sterility assurance for closed suction catheter systems

March 19, 2025 · DeviceView details →

Class IIOngoing

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

MEDLINE INDUSTRIES, LP - Northfield

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.

March 19, 2025 · DeviceView details →

Class IIOngoing

Medline Sterile Water, USP, 100mL, REF RDI30295

MEDLINE INDUSTRIES, LP - Northfield

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.

March 19, 2025 · DeviceView details →

Class IIOngoing

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

MEDLINE INDUSTRIES, LP - Northfield

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.

March 19, 2025 · DeviceView details →

Class IIOngoing

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 intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VIPER integrates multiple information feeds that supports the real-time distribution of critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, complication, and sophisticated alerting systems, VIPER offers improved support for the avoidance of adverse events.

Spectrum Medical Ltd.

Medical device software marketed without FDA clearance .

March 19, 2025 · DeviceView details →

Class IIOngoing

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 & 4.14.11, Sensor Configuration 45.n.

Siemens Healthcare Diagnostics Inc

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

March 19, 2025 · DeviceView details →

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/A

Avanos Medical, Inc.

Lack of sterility assurance for closed suction catheter systems

March 19, 2025 · DeviceView details →

Class IIOngoing

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

MEDLINE INDUSTRIES, LP - Northfield

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.

March 19, 2025 · DeviceView details →

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 Component: N/A

Avanos Medical, Inc.

Lack of sterility assurance for closed suction catheter systems

March 19, 2025 · DeviceView details →

Class IIOngoing

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 device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VISION / LIVE VUE integrates multiple information feeds that supports remote monitoring of near real-time critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, critical care scoring systems, and sophisticated alerting systems, VISION / LIVE VUE offers improved support for ensuring compliance to hospital-specific protocols. The software solution also allows for big data queries, routine reporting, and review of quality performance metrics.

Spectrum Medical Ltd.

Medical device software marketed without FDA clearance .

March 19, 2025 · DeviceView details →

Class IIOngoing

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

MEDLINE INDUSTRIES, LP - Northfield

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.

March 19, 2025 · DeviceView details →

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A

Avanos Medical, Inc.

Lack of sterility assurance for closed suction catheter systems

March 19, 2025 · DeviceView details →

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, T-Piece Component: N/A

Avanos Medical, Inc.

Lack of sterility assurance for closed suction catheter systems

March 19, 2025 · DeviceView details →

Class IIOngoing

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

MEDLINE INDUSTRIES, LP - Northfield

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.

March 19, 2025 · DeviceView details →

Class IIOngoing

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

MEDLINE INDUSTRIES, LP - Northfield

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.

March 19, 2025 · DeviceView details →

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 Component: N/A

Avanos Medical, Inc.

Lack of sterility assurance for closed suction catheter systems

March 19, 2025 · DeviceView details →

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