PlainRecalls

Medical Devices Recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

27,372 recalls · Page 100 of 548

FDA Devices Moderate Nov 1, 2023

TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005

Acclarent, Inc.
FDA Devices Moderate Nov 1, 2023

Lem Fertility hCG Pregnancy Urine Test REF 100-12

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System

GE Healthcare
FDA Devices Moderate Nov 1, 2023

SOZO Bilateral Arm L-Dex Software

Impedimed Limited
FDA Devices Moderate Nov 1, 2023

OMTMO One Step Ovulation (LH) Test Strips REF 200-07

Universal Meditech Inc.
FDA Devices Critical Nov 1, 2023

Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack

Cardinal Health 200, LLC
FDA Devices Moderate Nov 1, 2023

One Step Pregnancy Test REF 100-01

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

CVS PCSU SJH, REF SJCV48J

American Contract Systems, Inc.
FDA Devices Moderate Nov 1, 2023

Pediatric Heart SJH, REF SJPH34K

American Contract Systems, Inc.
FDA Devices Critical Nov 1, 2023

Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack

Cardinal Health 200, LLC
FDA Devices Moderate Nov 1, 2023

OPMI LUMERA 300, REF 6137

Carl Zeiss Suzhou Co., Ltd.
FDA Devices Moderate Nov 1, 2023

PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis

Smith & Nephew, Inc.
FDA Devices Moderate Nov 1, 2023

Cath Cardiac Pack, REF IHCC03V

American Contract Systems, Inc.
FDA Devices Moderate Nov 1, 2023

DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

Robotics Pack, REF SSRO22D

American Contract Systems, Inc.
FDA Devices Moderate Nov 1, 2023

DiagnosUS One Step LH Ovulation Test Strip REF 200-07

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085

Omega Medical Imaging, Inc.
FDA Devices Moderate Nov 1, 2023

DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27

Universal Meditech Inc.
FDA Devices Critical Nov 1, 2023

Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack

Cardinal Health 200, LLC
FDA Devices Moderate Nov 1, 2023

HealthyWiser UriTest" UTI Test Strips REF 900-UTI

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

Sub Q Recorder Pack, REF BPRC87A

American Contract Systems, Inc.
FDA Devices Moderate Nov 1, 2023

JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis

Smith & Nephew, Inc.
FDA Devices Moderate Nov 1, 2023

HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Nov 1, 2023

DiagnosUS Ovulation Predictor Midstream REF 200-17

Universal Meditech Inc.
FDA Devices Critical Oct 25, 2023

Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.

Olympus Corporation of the Americas
FDA Devices Moderate Oct 25, 2023

SenSight Connector Plug, Model Number B31061.

Medtronic Neuromodulation
FDA Devices Moderate Oct 25, 2023

stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502

Tornier, Inc
FDA Devices Critical Oct 25, 2023

Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)

EITAN MEDICAL LTD
FDA Devices Moderate Oct 25, 2023

Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777

Cardinal Health 200, LLC
FDA Devices Moderate Oct 25, 2023

MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.

MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Oct 25, 2023

MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Generator, REF LF1944CR. electrosurgical instrument

MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Oct 25, 2023

HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002

Access Vascular, Inc
FDA Devices Moderate Oct 25, 2023

HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004

Access Vascular, Inc
FDA Devices Moderate Oct 25, 2023

Functional MR V1.0

OLEA MEDICAL
FDA Devices Moderate Oct 25, 2023

DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit

DeRoyal Industries Inc
FDA Devices Moderate Oct 25, 2023

MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF4418CR. electrosurgical instrument

MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Oct 18, 2023

Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.

Cardinal Health 200, LLC
FDA Devices Moderate Oct 18, 2023

Multichem P, Part Code 08P90-10

TECHNO-PATH MANUFACTURING LTD.
FDA Devices Moderate Oct 18, 2023

MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1

Mazor Robotics Ltd
FDA Devices Moderate Oct 18, 2023

Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.

Cardinal Health 200, LLC
FDA Devices Critical Oct 18, 2023

2008T HD SYS. W/O CDX BLUESTAR

Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Oct 18, 2023

REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130

Encore Medical, LP
FDA Devices Moderate Oct 18, 2023

Constellation Vision System, REF: 8065751150

Alcon Research, LLC

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