Medical Device Recalls

8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296

Intuitive Surgical, Inc.

MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR LAPAROTOMY CDS, REF CDS86001

Medline Industries, LP

Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF

Trinity Sterile, Inc.

Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical s

Paltop Advanced Dental Solutions Ltd

Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST

Remel Inc

FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051

Richard Wolf GmbH

Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test

Luminex Corporation

SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System

Abbott Diabetes Care, Inc.

DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12

Universal Meditech Inc.

TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog N

Howmedica Osteonics Corp.

Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL TRAY, 1000 ML B

Cardinal Health 200, LLC

nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring dosimeter used with the microSTAR re

Landauer

1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 3. M

Medline Industries, LP

BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Pa

GE Healthcare Finland Oy

DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, se

Beckman Coulter, Inc.

ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynt

FUJIFILM Healthcare Americas Corporation

DeRoyal HAND PACK, REF 89-10314.03

DeRoyal Industries Inc

Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 105

Mercury Enterprises, Inc. dba Mercury Medical

STRADIS HEALTHCARE, Vasc Vein, Item No.682-1583,

Stradis Medical, LLC dba Stradis Healthcare

Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in h

Siemens Healthcare Diagnostics, Inc.

Medline Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model N

MEDLINE INDUSTRIES, LP - Northfield

IntelliVue MP60. Product Number: M8005A.

Philips North America Llc

Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW Model/Catalog Number: 91829 Product Description: NON-Sterile syr

Jiangsu Shenli Medical Production Co., Ltd.

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instr

Olympus Corporation of the Americas

SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented

Waldemar Link GmbH & Co. KG (Mfg Site)

Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.

Aizu Olympus Co., Ltd.

Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.

BALT USA, LLC

Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, CVC KIT: 14 GA X 6 IN/CK-0471

ARROW INTERNATIONAL, LLC

TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histolog

Technidata S.A.