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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 281–300 of 1,000 recalls

Class IIOngoing

Medline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ67267B MRI DBS PACK DYNJ9814630O NEURO CDS-LF CDS983383L NEURO PACK DYNJ59397Q DYNJT7315 NEURO PACK-LF DYNJ25097I NEURO VP SHUNT/VAGAL NERVE-RF DYNJ21925S PK NEURO SHUNT BUMC DYNJT6428 RR-NEURO DBS HEAD PACK-LF DYNJ0785736M VP SHUNT SYNJ10307B

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →

Class IIOngoing

Medline convenience kits: ACL PACK DYNJ64161C ARTHROSCOPY PACK DYNJ47103D DYNJ67197G DYNJ85197A DYNJT4007 BASIC ACCESS PACK-LF DYNJ36698B BASIC BACK TRAY DYNJ89037 BASIC PEDI PACK-LF DYNJ0171446I DYNJ0171446J BASIC SPINE DYNJ910915A BREAST PACK DYNJ87587A BREAST PLASTIC PACK DYNJ84482C C SECTION DYNJ49172I CAROTID ENDARTERECTOMY PACK DYNJ48013L CENTRAL LINE PACK-LF DYNJ0220136S CERVICAL FUSION DYNJ908135B CERVICAL SPINE PACK DYNJ53044G C-SECTION DYNJ909099F DAVINCI PROSTATE PACK DYNJ61711C DEPAUL FOOT & ANKLE-LF DYNJ20010L DIEP PACK DYNJ64964J DYNJ43210K DYNJ61787F DYNJ87065 EAR CUSTOM PACK DYNJ82564A ENT FREE FLAP PACK SAFETY DYNJ54720D EP PACEMAKER SAFETY #1 DYNJ54722F EPCH EXTREMITY PACK DYNJ83095B EXTREMITY PACK DYNJ32934F EXTREMITY PACK-LF DYNJ68935B FISTULA PACK DYNJ66502B GENDER AFFIRMING SURGERY DYNJ66252F GYN LAPAROSCOPY PACK AHSC DYNJT8381 HAND PACK WATCHMAKER-LF DYNJ34580D HEAD & NECK PACK-LF DYNJ0282388T DYNJ88308 HIP SCOPE DYNJ907120D KNEE ARTHRO PACK DYNJ58404F KNEE ARTHROSCOPY PACK DYNJ84740A LAMI OVERHEAD PACK DYNJ46531Q LAMINECTOMY NEURO MPH DYNJT5271 LAMINECTOMY PACK DYNJ68785D LAP APPY PACK DYNJT6005 LAP CHOLE PACK DYNJ82087A LEVY PACK DYNJ83939C MAJOR LAP VCH DYNJ39217P MAJOR NEURO PACK-LF DYNJ0578916AA MAJOR PACK DYNJ58528J MINOR GEN PACK DYNJ61661B MINOR LAPAROTOMY PACK-LF DYNJ0753436P MINOR PACK DYNJ54968B NEURO PACK DYNJ67628D NEURO SHUNT PACK-LF DYNJ0578815W OMFS PACK DYNJ54400C OPEN HEART PACK DYNJT5008 OPEN HEART-LF DYNJ48260F OPEN LAPAROTOMY PACK DYNJ39247I DYNJ39247J PACEMAKER PACK DYNJ31461I DYNJ61411C PACK,ORTHO FLIP DYNJ65471B PED OPEN HEART PACK DYNJ45373G PLASTIC PACK DYNJ82495D PLASTICS PK - NO SYR DYNJ62433F PODIATRY PACK OP7809M PPE BUNDLE KIT DT13351A PROSTATE ROBOTIC PACK DYNJ84120C RADIAL ART LINE INSERTION ARTNC234 ROBOTIC GENERAL WHH DYNJT5376 ROBOTIC PACK DYNJ47978G RR-SPINE PACK DYNJ62643B SHOULDER ARTH PACK DYNJ58410D SHOULDER ARTHROSCOPY PACK DYNJ54477C DYNJT8391 SHOULDER PACK DYNJ61052B DYNJT3266 SHOULDER PACK-LF DYNJ0122428K PHS656414I SPINE PACK DYNJ64949C DYNJ83649B SPINE SHOULDER PACK DYNJ47104D STERILE ACCESS KIT DYNDA2664 TOTAL KNEE PACK DYNJ84741B TUBAL PACK DYNJ68253F UNIVERSAL PACK DYNJ83246B VA TAMPA GENERAL ROBOTIC PACK DYNJT6993 W.C. MINOR LAPAROTOMY PK-LF DYNJ0509186J ZALE OTOLOGY CDS CDS983181G

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →

Class IIOngoing

Medline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C DYNJ900004J DYNJ901779J DYNJ902900F EAR PACK DYNJ81419D ENT PACK DYNJ40498B HEAD & NECK CDS DYNJ901246J JEWISH DR SEVERTSON EAR DYNJ909252C JEWISH HEAD&NECK DYNJ909255C KIT HEAD AND NECK MHS DYNJ905364B MAJOR EAR CDS983347S MAJOR EAR FMOL LADY OF THE LAK DYNJ89581 MAJOR EAR PACK DYNJT4872 MAJOR HEAD AND NECK PACK DYNJ38985G MAJOR HEAD NECK PACK DYNJ45706B MZ EAR CDS DYNJ905642F PARATHYROID PACK DYNJ81389F PK,ENT-EAR DYNJ43700B SM-HEAD AND NECK PACK-LF DYNJ0780036W THYROID CDS CDS983693I TYMPANOPLASTY CDS982720S TYMPANOPLASTY MASTOIDECTOM DYNJ66231B TYMPANOPLASTY PACK-LF DYNJ62820D WH FACIAL HEAD AND NECK PACK DYNJ89028A WMC COCHLEAR IMPLANT ADD ON DYNJ907206G

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →

Class IIOngoing

Aligned Medical AMS16835 Fluids Kit RX

Windstone Medical Packaging, Inc.

Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.

April 27, 2026 · DeviceView details →

Class IIOngoing

Medline convenience kit: KIT: DRESSING CHANGE PED DYNDC3359

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →

Class IIOngoing

Medline convenience kits: BASIC EYE DYNJ905154I TUBAL LIGATION CDS CDS760053K

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →

Class IIOngoing

Medline convenience kits: 20CM CVC INSERTION KIT ECVC6805B 2L 8.5FR 16CM CVC INSERTION KIT ECVC8055A VANTEX PI CVC 7F, 3L, 20CM BUNDLE ECVC6915A ECVC6985B

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →

Class IIOngoing

Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ56297C PACEMAKER PK DYNJT3454 PACEMAKER/ICD PACK DYNJ33822L PAD OPEN HEART DYNJ900962O PEDIATRIC OPEN HEART DYNJ54238L DYNJT6766 STAZ BASIC VASCULAR DYNJ909794C VASCULAR ACCESS KIT CVI5323A VASCULAR CDS CDS983040M

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →

Class IIOngoing

Medline convenience kits: PORT A CATH DYNJ906818A

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →

Class IIOngoing

GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

GE Medical Systems Information Technologies Inc

GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).

April 24, 2026 · DeviceView details →

Class IIOngoing

Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected material numbers: 87629007, 60729458, 86566648;

Bayer Medical Care, Inc.

Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage before or during contrast injection, leading to procedure interruption.

April 24, 2026 · DeviceView details →

Class IIOngoing

Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

Intuitive Surgical, Inc.

Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.

April 24, 2026 · DeviceView details →

Class IIOngoing

GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

GE Medical Systems Information Technologies Inc

GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).

April 24, 2026 · DeviceView details →

Class IIOngoing

GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

GE Medical Systems Information Technologies Inc

GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).

April 24, 2026 · DeviceView details →

Class IIOngoing

CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3

GE Medical Systems Information Technologies Inc

Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charring or discoloration of thermal printer paper. Ignition of the paper could potentially result in serious thermal injury.

April 24, 2026 · DeviceView details →

Class IIOngoing

HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3

Devicor Medical Products Inc

Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.

April 24, 2026 · DeviceView details →

Class IIOngoing

Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation

Medartis AG

The cannulation of the CCS screw is not centered.

April 24, 2026 · DeviceView details →

Class IIOngoing

GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

GE Medical Systems Information Technologies Inc

GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).

April 24, 2026 · DeviceView details →

Class IIOngoing

GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

GE Medical Systems Information Technologies Inc

GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).

April 24, 2026 · DeviceView details →

Class IIOngoing

EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01

BERLIN HEART GMBH

Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.

April 24, 2026 · DeviceView details →

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