Medical Device Recalls
RSS ↗7,870 medical device recalls from federal enforcement feeds.
Showing 201–250 of 7,870
- Class II
Medical Device Recall · April 27, 2026
Medline convenience kits: BASIC DYNJ905869G BASIC PACK DYNJ68484B BIB GENERAL LAPAROSCOPY PA DYNJ58305 CHRISTUS CH PEDIATRIC BASIC DYNJ61167G CVC INSERTION BUNDLE CVI3940A DAVINKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class II
Medical Device Recall · April 27, 2026
Medline convenience kit: (82)LABOR & DELIVERY C-SECTION DYNJ907895FKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class II
Medical Device Recall · April 27, 2026
Medline convenience kits: DRIVELINE MANAGEMENT KIT EBSI1688 PORT DRESSING CHANGE KIT EBSI1328AKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class I
Medical Device Recall · April 27, 2026
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 40574This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
- Class II
Medical Device Recall · April 27, 2026
Medline convenience kit: IV START KIT W/HUBGUARD DYNDV2662Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class I
Medical Device Recall · April 27, 2026
BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405645.This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
- Class II
Medical Device Recall · April 27, 2026
Centurion convenience kits: CENTRAL LINE DRESSING SV43 FCP DYNDC2356B DIALYSIS CATHETER MAINTENANCE KIT DT17570 DIALYSIS DRESSING CHANGE KIT DT21370B DRESSING CHANGE TRAY - GOLD DT2111Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class II
Medical Device Recall · April 27, 2026
Medline convenience kits: ABD PACK DYNJ81673B BARIATRIC DYNJ902515K BARIATRIC + DYNJ904119O BARIATRIC CDS CDS983883J BWNBORO LAP CHOLE PACK-LF DYNJ32836B CCSB KARIN JWIRE LUMPECKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class II
Medical Device Recall · April 27, 2026
Medline convenience kit: HERNIA REPAIR TOTE DYNJ908337DKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class II
Medical Device Recall · April 27, 2026
Medline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS984853LKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class II
Medical Device Recall · April 27, 2026
Windstone Medical Packaging, Inc.
Aligned Medical AMS16835 Fluids Kit RXLidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
- Class II
Medical Device Recall · April 27, 2026
Medline EBSI Kit EBSI1534Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class II
Medical Device Recall · April 27, 2026
Medline convenience kit: KIT: DRESSING CHANGE PED DYNDC3359Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class II
Medical Device Recall · April 27, 2026
Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT PACK DYNJ56573B ENDOVASCULAR PACK DYNJ29135N EP DEVICE DYNJ65916B FULL LINE ANEURYSM CDS CDS983672Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class II
Medical Device Recall · April 27, 2026
Medline convenience kits: INPATIENT CENTRAL LN DRSG KIT DYNDC3525 PICC/CVC/MIDLINE DRSG CHG KIT DT13191A PORT A CATH CDS982047S VEIN ABLATION PACK DYNJ62889CKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class II
Medical Device Recall · April 27, 2026
Medline convenience kits: C-SECTION KIT DYNJ904305J C-SECTION PACK DYNJ69533CKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class I
Medical Device Recall · April 27, 2026
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400866, 405672, 405673, 405674, 405675This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
- Class I
Medical Device Recall · April 27, 2026
BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405621, 405735.This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
- Class II
Medical Device Recall · April 27, 2026
Oculus Technologies of Mexico, S.A. de C.V.
PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the product solution and the stainless steel spring and may result in visible discoloration and the presence of trace levels of metallic elements (including iron, chromium, and nickel) in the solution during use.
- Class II
Medical Device Recall · April 27, 2026
Medline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C DYNJ900004J DYNJ901779J DYNJ902900F EAR PACK DYNJ81419D ENT PACK DYNJ40498B HEAD & NECK CDS DYNJ901246J JEKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class II
Medical Device Recall · April 27, 2026
Medline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2716Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class II
Medical Device Recall · April 27, 2026
Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ56297C PACEMAKER PK DYNJT3454 PACEMAKER/ICD PACK DYNJ33822L PAD OPEN HEART DYNJ900962O PEDKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class II
Medical Device Recall · April 27, 2026
Medline convenience kits: PORT A CATH DYNJ906818AKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class II
Medical Device Recall · April 27, 2026
Medline convenience kits: FEMORAL BLOCK TRAY DYNJRA1739BKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class II
Medical Device Recall · April 27, 2026
Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRESSING CHANGE KIT EBSI1057A DIALYSIS DRESSING CHANGE EBSI1498 EBSI CVC DRESSING CHANGE KIT EKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class I
Medical Device Recall · April 27, 2026
BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405632.This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
- Class II
Medical Device Recall · April 27, 2026
Medline convenience kits: 20CM CVC INSERTION KIT ECVC6805B 2L 8.5FR 16CM CVC INSERTION KIT ECVC8055A VANTEX PI CVC 7F, 3L, 20CM BUNDLE ECVC6915A ECVC6985BKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class I
Medical Device Recall · April 27, 2026
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405637, 405707.This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
- Class II
Medical Device Recall · April 27, 2026
Medline convenience kits: DAVINCI MAIN DYNJ908031DKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class II
Medical Device Recall · April 27, 2026
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 DYNKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class II
Medical Device Recall · April 27, 2026
MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D PORT-A-CATH DYNJ63276GKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class I
Medical Device Recall · April 27, 2026
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405671.This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
- Class II
Medical Device Recall · April 27, 2026
Medline convenience kits: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I GENERAL ROBOTICS PACK DYNJT8308 GYN LAP CDS860087Q GYN LAPAROSCOPY DYNJ910084C GYN LAPAROSCOPY CDS CDS98237Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class II
Medical Device Recall · April 27, 2026
Medline convenience kits: BASIC EYE DYNJ905154I TUBAL LIGATION CDS CDS760053KKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class II
Medical Device Recall · April 27, 2026
BLOCK TRAY DYNJRA2119A INDWELLING NERVE BLOCK DYNJRA1011AKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Class II
Medical Device Recall · April 24, 2026
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 forDue 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.
- Class II
Medical Device Recall · April 24, 2026
GE Medical Systems Information Technologies Inc
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 DGE 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).
- Class II
Medical Device Recall · April 24, 2026
GE Medical Systems Information Technologies Inc
CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3Electrical 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.
- Class II
Medical Device Recall · April 24, 2026
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: 87629Supplier 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.
- Class II
Medical Device Recall · April 24, 2026
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
- Class II
Medical Device Recall · April 24, 2026
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
- Class II
Medical Device Recall · April 24, 2026
GE Medical Systems Information Technologies Inc
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, PhysioGE 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).
- Class II
Medical Device Recall · April 24, 2026
GE Medical Systems Information Technologies Inc
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, PatienGE 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).
- Class II
Medical Device Recall · April 24, 2026
GE Medical Systems Information Technologies Inc
GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(WithGE 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).
- Class II
Medical Device Recall · April 24, 2026
GE Medical Systems Information Technologies Inc
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, PatiGE 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).
- Class II
Medical Device Recall · April 24, 2026
Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixationThe cannulation of the CCS screw is not centered.
- Class II
Medical Device Recall · April 24, 2026
GE Medical Systems Information Technologies Inc
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 DetectionGE 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).
- Class II
Medical Device Recall · April 23, 2026
Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF: 33614 33616 33618 33620 33622 33624Due to stain present on the surface of affected foley catheters.
- Class II
Medical Device Recall · April 23, 2026
Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044Temperature probe devices lack FDA clearance.
- Class II
Medical Device Recall · April 23, 2026
Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042Temperature probe devices lack FDA clearance.