Medical Device Recalls

Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software

LivaNova Deutschland GmbH

HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.

Draeger, Inc.

Model A710 Intellis Clinician Programmer Application, version 2.0.97

Medtronic Neuromodulation

ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA

American Contract Systems Inc

HAND PACK 297829--Procedure Kit Catalog Number: RGHN04I

American Contract Systems Inc

GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with Apex

GE Medical Systems Information Technologies Inc

Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK

Bard Peripheral Vascular Inc

Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;

Mint Medical GmbH

SKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409 LS SKYN NON LATEX LUBRICATED CONDOM 3CT, SKU 900794 SKYN ELITE NON

Family Dollar Stores, Llc.

Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

Boston Scientific Corporation

Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH

Randox Laboratories Ltd.

HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840

Maquet Medical Systems USA

GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled

Wipro GE Healthcare Private Ltd.

EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108

Encore Medical, LP

Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and dat

GE Medical Systems, LLC

Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC

Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicab

Draeger, Inc.

C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,

Baxter Healthcare Corporation

Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47

Exactech, Inc.

TOTAL HIP PACK , Model No SMTH06O SMTH06P

American Contract Systems Inc

NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSt

Avanos Medical, Inc.

Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Re

Olympus Corporation of the Americas

Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3

Securitas Healthcare LLC

RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998

Cardinal Health

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR CERVICAL FUSION PACK

Medline Industries, LP

Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY

American Contract Systems Inc.

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Pre

Merit Medical Systems, Inc.

QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests

Quidel Corporation

syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers wit

Siemens Medical Solutions USA, Inc

Brand Name: MEDLINE Product Name: SYR 3ML L/L RED Model/Catalog Number: 91820 Product Description: NON-Sterile syring

Jiangsu Shenli Medical Production Co., Ltd.