Medical Device Recalls

Ringed DxI Reaction Vessels (RVs)

Beckman Coulter, Inc.

PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM

Ethicon Endo Surgery, LLC

CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031

Philips North America Llc

Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK

Medline Industries, LP

Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system

SEDECAL SA

Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventio

ROUTE 92 MEDICAL INC

VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package c

Ortho-Clinical Diagnostics, Inc.

Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator

Hamilton Medical, Inc.

RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 1

Teleflex Medical Europe Ltd

Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.

Abiomed, Inc.

DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01

American Contract Systems Inc

basixSKY Inflation Device, REF: SKY1802

Merit Medical Systems, Inc.

Anesthesia Set Coax 180, MP03384

Draeger Medical, Inc.

Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention an

Baxter Healthcare Corporation

Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray imag

Palodex Group Oy

HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)

AMD Medicom Inc.

SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.

SoClean, Inc

MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.

Cordis US Corp

Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator

Respironics California, LLC

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE

Medtronic Perfusion Systems

regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenience kit

ROi CPS LLC

MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a

Getinge Usa Sales Inc

Programmable Diagnostic Computer

Siemens Medical Solutions USA, Inc

Impella CP Smart Assist Set; Product Code: 1000402;

Abiomed, Inc.

Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory s

Abiomed, Inc.

SafeStar 55 Plus Filter. Bidirectionally breathing system filter.

Draeger, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001373;

Beaver Visitec International, Inc.

Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; V

Medline Industries, LP

On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33

On-X Life Technologies, Inc.

Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Conn

Silex Medical, LLC