Medical Device Recalls

DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate

DePuy Mitek, Inc., a Johnson & Johnson Co.

Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: P

B Braun Medical Inc

Atellica IM 1600 Analyzer, SMN 11066000

Siemens Healthcare Diagnostics, Inc

Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K13084

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS

ReCor Medical Inc.

Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUC

MEDLINE INDUSTRIES, LP - Northfield

QUCARE Total Cholesterol in vitro diagnostic test REF: 6407

DFI Co., Ltd.

Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ9

Medline Industries, LP

Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter

Boston Scientific Corporation

MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C

MEDLINE INDUSTRIES, LP - Northfield

STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A P

Ethicon, Inc.

Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space

B Braun Medical Inc

ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stab

Zimmer, Inc.

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheel

Max Mobility LLC

HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's f

Baxter Healthcare Corporation

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

B-K Medical A/S

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code

Smiths Medical ASD Inc.

ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device

J&T Health and Wellness LLC

Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surgical devic

Carefusion 2200 Inc

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06 0199 Product Description: A clear,

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

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP

Covidien LP

Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human se

Siemens Healthcare Diagnostics, Inc.

BD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version 3.9.1.9

CareFusion 303, Inc.

GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system.

GE Medical Systems China Co., Ltd.

IntelliVue MP80. Product Number: M8008A.

Philips North America Llc

SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Sy

Philips North America Llc

MAGNETOM Skyra fit. Model Number: 10849580.

Siemens Medical Solutions USA, Inc

Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW LIDO Model/Catalog Number: 91854 Product Description: NON-Steri

Jiangsu Shenli Medical Production Co., Ltd.

ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605

SCIENCE & BIO MATERIALS

AC-powered adjustable medical beds with built-in electric DC actuators and controls.

Umano Medical, Inc.