41 results
·
34ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
×
Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only
FDA Recall
Open, Classified
·Stryker Sustainability Solutions·Product code NLH·May 10, 2024
REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
FDA Recall
Open, Classified
·Stryker Sustainability Solutions·Product code JOW·April 14, 2023
Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solution Color Cuff 18" (Red), Quick Connect Dual Port Single Bladder REF 5921-018-135 Stryker Sustainability Solution Color Cuff 18" (Red) Dual Port Single Bladder REF 5921-018-235.
FDA Recall
Open, Classified
·Stryker Sustainability Solutions·Product code KCY·March 12, 2026
CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP, e) REF 21-7309-24JP. Computerized Ambulatory Delivery Device
FDA Recall
Open, Classified
·Smiths Medical ASD Inc.·Product code FPA·December 9, 2022
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
FDA Recall
Open, Classified
·Smiths Medical ASD Inc.·Product code FPA·December 9, 2022
CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF 21-7609-24JP, g) REF 21-7624-24JP, h) REF 21-7649-24JP Computerized Ambulatory Delivery Device
FDA Recall
Open, Classified
·Smiths Medical ASD Inc.·Product code FPA·December 9, 2022
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8) REF 21-7333-24, 9) REF 21-7336-24, 10) REF 21-7339-24, 11) REF 21-7343-24, 12) REF 21-7349-24, 13) REF 21-7359-24, 14) REF 21-7383-24, 15) REF 21-7390-24, 16) REF 21-7391-24, 17) REF 21-7394-24, 18) REF 21-7395-24, 19) REF 21-7301-24JP, 20) REF 21-7302-24JP, 21) REF 21-7321-24JP, 22) REF 21-7322-24JP, 23) REF 21-7359-24JP, 24) REF 21-7394-24JP
FDA Recall
Open, Classified
·Smiths Medical ASD Inc.·Product code FPA·December 9, 2022
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) REF 21-7310-24, 7) REF 21-7322-24, 8) REF 21-7323-24, 9) REF 21-7324-24, 10) REF 21-7333-24, 11) REF 21-7343-24, 12) REF 21-7346-24, 13) REF 21-7349-24, 14) REF 21-7359-24, 15) REF 21-7363-24, 16) REF 21-7383-24, 17) REF 21-7391-24, 18) REF 21-7394-24, 19) REF 21-7600-24, 20) REF 21-7609-24, 21) REF 21-7624-24, 22) REF 21-7649-24, 23) REF 21-7301-24JP, 24) REF 21-7302-24JP, 25) REF 21-7308-24JP, 26) REF 21-7309-24JP, 27) REF 21-7322-24JP, 28) REF 21-7359-24JP, 29) REF 21-7394-24JP, 30) REF 21-7600-24JP, 31) REF 21-7609-24JP, 32) REF 21-7624-24JP, 33) REF 21-7649-24JP. Computerized Ambulatory Delivery Device
FDA Recall
Open, Classified
·Smiths Medical ASD Inc.·Product code FPA·December 9, 2022
IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code OAD·November 28, 2018
IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code OAD·November 28, 2018
Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code OAD·November 28, 2018
REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
FDA Recall
Open, Classified
·Stryker Sustainability Solutions·Product code KCY·May 31, 2024
Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
FDA Recall
Open, Classified
·Fresenius Kabi USA, LLC·Product code FRN·March 10, 2023
Getinge Flow-e Anesthesia System, Part No. 6887900
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code BSZ·December 22, 2022
Getinge Flow-c Anesthesia System, Part No. 6887700
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code BSZ·December 22, 2022
Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code BSZ·December 22, 2022
Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures.
FDA Recall
Open, Classified
·Stryker Sustainability Solutions·Product code NLQ·January 19, 2021
Alaris System PC Unit Model 8015
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code FRN·August 4, 2020
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·June 14, 2021
A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code MNS·June 14, 2021