Medical Devices Recalls

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

B-K Medical A/S

Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.

OSSTEM Implant Co., Ltd.

Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology Informat…

Spacelabs Healthcare, Ltd.

Astemrey Recalls Y'all Can DIY Liquid Bioethanol Fireplace Fuel Containers Due to Risk of Serious Injury or Death from Flash Fire; Violates Mandatory…

STARKIM KIMYA SAN.TIC. A.S, of Turkey

Lezyne USA Recalls Bicycle Floor Pumps Due to Serious Injury Hazard

Alcon PRECISION1 One-Day Contact Lenses, -2.25D.

Alcon Research LLC

Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;

PHILIPS MEDICAL SYSTEMS

IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio

IMPRIS Imaging Inc

Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;

DAYE (ANNE'S DAY LTD)

ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5

ICU Medical, Inc.

Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;

DAYE (ANNE'S DAY LTD)

9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;

DAYE (ANNE'S DAY LTD)

Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;

DAYE (ANNE'S DAY LTD)

18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;

DAYE (ANNE'S DAY LTD)

ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35

ICU Medical, Inc.

IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida

IMPRIS Imaging Inc

ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS

ICU Medical, Inc.

Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See…

Alcon Research LLC

BD Pyxis Pro MedStation Main, REF: 1155-00

CareFusion 303, Inc.

Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile,…

ENDOMAGNETICS LTD

ICU Medical ChemosafeLock Connecter REF: KL-FNU3

ICU Medical, Inc.

ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34

ICU Medical, Inc.

ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20

ICU Medical, Inc.

ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10

ICU Medical, Inc.

ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360

ICU Medical, Inc.

Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000;

DAYE (ANNE'S DAY LTD)

9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;

DAYE (ANNE'S DAY LTD)

VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.

Canon Medical System, USA, INC.

ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955

ICU Medical, Inc.

ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011

ICU Medical, Inc.

Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;

DAYE (ANNE'S DAY LTD)

ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3

ICU Medical, Inc.

SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system

Surgical Theater Inc

Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality

Surgical Theater Inc

Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;

PHILIPS MEDICAL SYSTEMS

CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. The…

Beckman Coulter, Inc.

Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Descriptio…

Aesculap Inc

Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.

Trividia Health, Inc.

ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138

ICU Medical, Inc.

Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system

Surgical Theater Inc

ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511

ICU Medical, Inc.

SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality

Surgical Theater Inc

Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description: REDU…

Aesculap Inc

Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Versio…

Medistim Asa

ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S

ICU Medical, Inc.

ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900

ICU Medical, Inc.

ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150

ICU Medical, Inc.

Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-01 139045-01…

CareFusion 303, Inc.

SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood Collec…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT0911…

BALT USA, LLC