342 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Hypoguard, DiaScreen 4pH, Reagent Strips for Urinalysis, 100 strips, Cat. No. D11400.
FDA Recall
Terminated
·ARKRAY USA INC.·Product code LJX·March 24, 2010
EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
FDA Recall
Terminated
·Dako Denmark A/S Produktionsvej 42 Glostrup Denmark·Product code LDT·July 6, 2016
Prolieve Thermodilatation Catheter Kit, a Transurethral Microwave Therapy (TUMT) System, for BPH (Benign Prostatic Hyperplasia) Thermotherapy, Material Numbers M0068808022 and M0068808170.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code MEQ·July 20, 2009
MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)
FDA Recall
Open, Classified
·Product code OEZ·May 4, 2026
Quick Connect Adapter Model #CSS-QA-Adapter MaxTorque(R) Maxtorque Quick Connect Lot #s: 1014001 & 1101011, QTY 1 NON STERILE MAT:17-4PH The intended use: Used to stabilize and aid in the fixation of fractures, fusions, and osteotomies.
FDA Recall
Terminated
·Orthohelix Surgical Designs Inc·Product code LXH·October 16, 2009
Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove, MN 55369 USA. Intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men greater or equal to 50 years of age with a prostate volume greater than or equal to 30cm3 and less than or equal to 80cm3. The Rezum System is also indicated for treatment of prostates with hyperplasia of the central zone and/or a median lobe.
FDA Recall
Terminated
·NXTHERA·Product code KNS·July 28, 2017
American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber optic laser for treatment of BPH (Benign Prostatic Hyperplasia). AMS Innovative Center, San Jose, CA 95134
FDA Recall
Terminated
·AMS Innovative Center San Jose·Product code GEX·June 18, 2007
ABL 5 Capillary Adaptor (a connection that fits the capillary tube on to the aspirator on the ABL 5 & BPH 5 Analyzers), in vitro diagnostic accessory, Part Number: 906-018.
FDA Recall
Terminated
·Radiometer America Inc·Product code CHL·June 9, 2005
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)
FDA Recall
Open, Classified
·Given Imaging Ltd. New Industrial Park·Product code FFT·June 3, 2025
Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX.
FDA Recall
Terminated
·Synthes, Inc.·Product code FZX·February 17, 2015
PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only Rx Product Usage: The contents of these vials are used in conjunction with a nebulizer for the induction of sputum production where sputum production is indicated.
FDA Recall
Terminated
·Pharmacaribe llc·Product code CAF·December 29, 2015
Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3.
FDA Recall
Terminated
·Medtronic Neuromodulation·Product code GEI·February 27, 2013
AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.S. Device Description The AQUABEAM Robotic System is intended for use in patients suffering from lower urinary tract symptoms resulting from benign prostatic hyperplasia (BPH).
FDA Recall
Terminated
·PROCEPT BIOROBOTICS CORPORATION·Product code PZP·March 6, 2019
STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
FDA Recall
Open, Classified
·Product code JIN·October 2, 2023
NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-456
FDA Recall
Open, Classified
·NxStage Medical Inc·Product code KPO·May 14, 2024
Prostatron Praktis Type II for Transurethral Microwave Thermotherapy. The Prostatron is a computer-controlled device designed to deliver microwave energy to the prostrate for the treatment of BPH (Benign Prostatic Hyperplasia). The Prostatron utilizes a transurethral microwave antenna, with simultaneous urethral cooling, to heat the prostate. This heating process is regulated through feedback from a series of temperature sensors.
FDA Recall
Terminated
·Urologix, Inc.·Product code MEQ·December 10, 2003
Esaote brand Formul@ ECG System; part 9704220000.
FDA Recall
Terminated
·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003
Esaote brand ArchiWin Colour ECG System; part 9704325000.
FDA Recall
Terminated
·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003
Esaote brand Archimed 4220 ECG System; part 9704220000.
FDA Recall
Terminated
·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003
Esaote brand Formula for Archimed ECG System; part 9704220000.
FDA Recall
Terminated
·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003