17 results · 13ms · Sources: EU EUDAMED, US FDA

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GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25MM; Emission Computed Tomography System

FDA Recall
Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 19, 2022

Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt Air Pro EX, Adapt Convertible, Adapt Convertible EX), sofware version 1.3.0; Mattress, Air Flotation, Alternating Pressure

FDA Recall
Open, Classified ·Agiliti Health Ellis·Product code FNM·January 21, 2026

Stryker Arise 1000EX mattress, Part Number 2236000000

FDA Recall
Open, Classified ·Stryker Medical Division of Stryker Corporation·Product code FNM·October 31, 2025

Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix)

FDA Recall
Open, Classified ·Turncare, Inc·Product code FNM·November 1, 2023

Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-69 (Fix)

FDA Recall
Open, Classified ·Turncare, Inc·Product code FNM·August 10, 2023

VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702

FDA Recall
Open, Classified ·Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland·Product code NKB·November 3, 2022

Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power chair

FDA Recall
Open, Classified ·mo-Vis BVBA Biebuyckstraat 15D Nevele Belgium·Product code KNN·November 28, 2023

MEDLINE INDUSTRIES Medline Catheter Insertion Tray Medline Foley Without Catheter Without Balloon Model Number: DYND10160

FDA Recall
Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code FCM·May 25, 2022

Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 Intended for urinary drainage from the bladder of a patient

FDA Recall
Open, Classified ·Cardinal Health·Product code FCM·November 1, 2022

Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450 Intended for urinary drainage from the bladder of a patient

FDA Recall
Open, Classified ·Cardinal Health·Product code FCM·November 1, 2022

Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the bladder of a patient

FDA Recall
Open, Classified ·Cardinal Health·Product code FCM·November 1, 2022

Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450LF Intended for urinary drainage from the bladder of a patient.

FDA Recall
Open, Classified ·Cardinal Health·Product code FCM·November 1, 2022

Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for urinary drainage from the bladder of a patient

FDA Recall
Open, Classified ·Cardinal Health·Product code FCM·November 1, 2022

Medline Convenience kits labeled as: 1) URETEROSCOPY CDS SC-LF, Pack Number CDS983922F ; 2) URETEROSCOPY TRAY-RF, Pack Number DYNJ27442U ; 3) URETHROPLASTY PACK, Pack Number DYNJ39700B ; 4) RRP PACK, Pack Number DYNJ44109B ; 5) PROSTATECTOMY PACK-LF , Pack Number DYNJ66109A ; 6) PERINEAL PACK , Pack Number DYNJ69895; 7) LIVER 2018, Pack Number DYNJ905655A; 8) UROLOGY PACK, Pack Number DYNJT2255M

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FCM·April 8, 2024

Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLE, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover" UNIVERSAL TRAY, 1000 ML BASIN, BZK SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover" UNIVERSAL TRAY, 1200 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 10 CC PRE-FILLED SYRINGE; Dover" 100% SILICONE FOLEY INSERTION TRAY, 18 FR (6.0 MM), 5 CC, PREP TRAY; Dover" HYDROGEL COATED LATEX FOLEY INSERTION TRAY, 18 FR (6.0 MM), 5 CC, PREP TRAY; Dover" HYDROGEL COATED LATEX FOLEY INSERTION TRAY, 16 FR (5.3 MM), 5 CC, PREP TRAY; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 10 CC PRE-FILLED SYRINGE; Dover" 100% SILICONE FOLEY INSERTION TRAY, 16 FR (5.3 MM), 5 CC, PREP TRAY; Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, DRAIN TUBE, PREP TRAY; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLE, 18 FR (6.0 MM), 5 CC, 2000 ML BAG; Dover" UNIVERSAL TRAY, 1000 ML BASIN, BZK SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover" URINE METER ADD-A-FOLEY TRAY, 400 ML, NEEDLE SAMPLING, DRAIN SPOUT, PREP TRAY; Dover" SILICONE ELASTOMER COATED LATEX FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG; Dover" 100% SILICONE FOLEY CATHETER KIT, 5 CC, 2-WAY, 16 FR (5.3 MM), LUBE, STRL WATER, 10CC SYRINGE; Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, DRAIN TUBE, PREP TRAY; Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, A/R CHAMBER, DRAIN SPOUT, PREP TRAY; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE

FDA Recall
Open, Classified ·Cardinal Health 200, LLC·Product code FCM·December 4, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. LIVER 2018, Model Number: DYNJ905655A;

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FCM·May 15, 2023

Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a patient

FDA Recall
Open, Classified ·Cardinal Health·Product code FCM·November 1, 2022