Medical Device Recalls

ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110

Philips North America Llc

Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant

Paragon 28, Inc.

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

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

Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC,

American Contract Systems, Inc.

FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.

B Braun Medical Inc

Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) install

Foundation Medicine, Inc.

Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile

Stradis Healthcare

JAGTOME RX 49-20-260-035 Material Number: M00573000

Boston Scientific Corporation

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER S

Exactech, Inc.

Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09

BALT USA, LLC

PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-

SPINEART SA

smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as foll

Smiths Medical ASD Inc.

Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DY

MEDLINE INDUSTRIES, LP - Northfield

Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended

Zyno Medical LLC

Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/C

Encore Medical, LP

Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Me

MEDLINE INDUSTRIES, LP - Northfield

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Li

Elekta, Inc.

EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base

MicroPort Orthopedics Inc.

Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A Component: N/A

Alcon Research LLC

Percept BrainSense Implantable Neurostimulator (INS), Model B35200

Medtronic Neuromodulation

Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK

MEDLINE INDUSTRIES, LP - Northfield

Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181060

TELEFLEX LLC

ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151

Siemens Healthcare Diagnostics, Inc.

NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)

Draeger Medical, Inc.

MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839

Medline Industries, LP

Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304

Cook Incorporated

Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.

Abbott Molecular, Inc.

Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion

Covidien Llc

RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to m

Mechatronics USA