17 results · 21ms · Sources: EU EUDAMED, US FDA

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Medline Convenience kits labeled as: 1) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number DYND30212; 2) PROCESSING KIT 3 PTE0000204 , Pack Number DYNJ65728A ; 3) 30ML KIT, Pack Number DYNJ82155A ; 4) DISSECTION, Pack Number DYNJ85191; 5) FLAP HARVEST PACK , Pack Number DYNJ58575C ; 6) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number DYND30212H ; 7) FLAP HARVEST PACK, Pack Number DYNJ58575C

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FMH·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

Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, LUER LOCK SAMPLING PORT, A/R DEVICE, DRAIN SPOUT, PREP TRAY; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover" UNIVERSAL TRAY, 1000 ML BASIN, BZK SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M FOLEY TRAY, COUD TIP, 16FR (5.3 MM), 5CC; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG (2-person); Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M FOLEY TRAY, COUD TIP, 18FR (6.0 MM), 5CC; Dover" PREMIUM URINE DRAINAGE ADD-A-FOLEY TRAY, LUER-LOCK, DRAIN SPOUT, CATHETER SECUREMENT DEVICE

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

MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01

FDA Recall
Open, Classified ·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023

MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01

FDA Recall
Open, Classified ·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023

MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01

FDA Recall
Open, Classified ·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023

MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01

FDA Recall
Open, Classified ·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023

Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates.

FDA Recall
Open, Classified ·Hamilton Medical, Inc.·Product code BSK·June 20, 2017

Puritan Bennett Cuff Pressure Manager, REF: 180-03

FDA Recall
Open, Classified ·Covidien·Product code BSK·August 22, 2023

bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.

FDA Recall
Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·November 30, 2023

bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Recall
Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025

bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Recall
Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025

Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Recall
Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025

bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.

FDA Recall
Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·September 4, 2024

bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Recall
Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025

UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Recall
Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Recall
Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025