PlainRecalls

Medical Devices Recalls

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

27,372 recalls · Page 99 of 548

FDA Devices Moderate Nov 15, 2023

Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-230-005

Stryker Corporation

FDA Devices Moderate Nov 15, 2023

Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm

Securitas Healthcare LLC

FDA Devices Moderate Nov 15, 2023

30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.

B. Braun Medical, Inc.

FDA Devices Moderate Nov 15, 2023

GOODSENSE DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GOODSENSE DENTURE CLEAN OVRNT TAB 40CT, SKU 906023

Family Dollar Stores, Llc.

FDA Devices Critical Nov 15, 2023

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC

Olympus Corporation of the Americas

FDA Devices Moderate Nov 15, 2023

AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.

B. Braun Medical, Inc.

FDA Devices Moderate Nov 15, 2023

Zenition 50 & 70 Mobile Surgery C-arm

Philips North America

FDA Devices Moderate Nov 8, 2023

LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.

Medtronic Neuromodulation

FDA Devices Moderate Nov 8, 2023

Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN…

Nova Biomedical Corporation

FDA Devices Moderate Nov 8, 2023

Coapt Dome Electrode, Gen2 system, cutaneous electrode

Coapt LLC

FDA Devices Moderate Nov 8, 2023

***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive i…

Siemens Medical Solutions USA, Inc

FDA Devices Critical Nov 8, 2023

Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catalog Number X9…

Asensus Surgical Inc

FDA Devices Moderate Nov 8, 2023

Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty

Corin Ltd

FDA Devices Moderate Nov 8, 2023

RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000

Randox Laboratories Ltd.

FDA Devices Moderate Nov 8, 2023

Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator

Abbott

FDA Devices Moderate Nov 8, 2023

Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Nov 8, 2023

Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 57400 S…

Nova Biomedical Corporation

FDA Devices Moderate Nov 8, 2023

RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000

Randox Laboratories Ltd.

FDA Devices Moderate Nov 8, 2023

Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.

Smiths Medical ASD Inc.

FDA Devices Moderate Nov 8, 2023

McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only

Covidien

FDA Devices Moderate Nov 8, 2023

RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)

Randox Laboratories Ltd.

FDA Devices Moderate Nov 8, 2023

AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324

MICROVENTION INC.

FDA Devices Moderate Nov 8, 2023

HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A00005…

Baxter Healthcare Corporation

FDA Devices Moderate Nov 8, 2023

RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical information, …

RAYSEARCH LABORATORIES AB

CPSC Moderate Nov 2, 2023

UncleWu Life Recalls Infant Bath Seats Due to Drowning Hazard; Violation of Bath Seat Requirements; Sold Exclusively on Amazon.com (Recall Alert)

FDA Devices Moderate Nov 1, 2023

Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc

FDA Devices Critical Nov 1, 2023

Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack

Cardinal Health 200, LLC

FDA Devices Moderate Nov 1, 2023

Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System

GE Healthcare

FDA Devices Moderate Nov 1, 2023

LAVH, REF BBLV21C

American Contract Systems, Inc.

FDA Devices Moderate Nov 1, 2023

DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10

Universal Meditech Inc.

FDA Devices Moderate Nov 1, 2023

Robotics Pack SAH, REF SAR530M

American Contract Systems, Inc.

FDA Devices Moderate Nov 1, 2023

Robotics Pack, REF SJVO56B

American Contract Systems, Inc.

FDA Devices Critical Nov 1, 2023

Monoject 20 mL Syringe Luer-Lock Tip Soft Pack

Cardinal Health 200, LLC

FDA Devices Moderate Nov 1, 2023

PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS

Universal Meditech Inc.

FDA Devices Moderate Nov 1, 2023

SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO

SynCardia Systems LLC

FDA Devices Moderate Nov 1, 2023

Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc

FDA Devices Moderate Nov 1, 2023

PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10

Universal Meditech Inc.

FDA Devices Moderate Nov 1, 2023

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

Omega Medical Imaging, Inc.

FDA Devices Moderate Nov 1, 2023

Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc

FDA Devices Critical Nov 1, 2023

8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System

B. Braun Medical, Inc.

FDA Devices Moderate Nov 1, 2023

DiagnosUS Pregnancy Test Midstream REF 100-17

Universal Meditech Inc.

FDA Devices Moderate Nov 1, 2023

Universal Viewer Workflow Manager, Image processing radiological system

GE Healthcare

FDA Devices Moderate Nov 1, 2023

Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc

FDA Devices Moderate Nov 1, 2023

Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. …

Maquet Cardiovascular, LLC

FDA Devices Moderate Nov 1, 2023

PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE

Universal Meditech Inc.

FDA Devices Moderate Nov 1, 2023

Vasc. Open CVOR SJH, REF SJVO56B

American Contract Systems, Inc.

FDA Devices Moderate Nov 1, 2023

Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc

FDA Devices Critical Nov 1, 2023

Astral 100 and Astral 150 ventilators

ResMed Ltd.

FDA Devices Critical Nov 1, 2023

8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System

B. Braun Medical, Inc.

FDA Devices Moderate Nov 1, 2023

Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1

Smiths Medical ASD Inc.