PlainRecalls

Medical Devices Recalls

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

27,372 recalls · Page 33 of 548

FDA Devices Moderate May 7, 2025

Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical May 7, 2025

GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012

GE Medical Systems China Co., Ltd.

FDA Devices Moderate May 7, 2025

Medline Sterile Water, USP, 100mL, REF RDI30295

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate May 7, 2025

IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a very cold Free…

Boston Scientific Corporation

FDA Devices Moderate May 7, 2025

Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical May 7, 2025

GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200

GE Medical Systems China Co., Ltd.

FDA Devices Critical May 7, 2025

GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002

GE Medical Systems China Co., Ltd.

FDA Devices Critical May 7, 2025

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

GE Medical Systems China Co., Ltd.

FDA Devices Moderate May 7, 2025

Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual …

Defibtech, LLC

FDA Devices Critical May 7, 2025

GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012

GE Medical Systems China Co., Ltd.

FDA Devices Moderate May 7, 2025

Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description:…

Spectrum Medical Ltd.

FDA Devices Moderate May 7, 2025

epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configura…

Siemens Healthcare Diagnostics Inc

FDA Devices Moderate May 7, 2025

Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product D…

Olympus Corporation of the Americas

FDA Devices Moderate May 7, 2025

IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a very cold Fre…

Boston Scientific Corporation

FDA Devices Moderate May 7, 2025

Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Hyperthermia…

Belmont Instrument LLC

FDA Devices Moderate May 7, 2025

Enhanced Verify Evaluation Handset (CFN HH90130FA)

Medtronic Neuromodulation

FDA Devices Moderate May 7, 2025

Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)

Defibtech, LLC

FDA Devices Moderate May 7, 2025

Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented …

Waldemar Link GmbH & Co. KG (Mfg Site)

FDA Devices Critical May 7, 2025

GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002

GE Medical Systems China Co., Ltd.

FDA Devices Critical May 7, 2025

GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000

GE Medical Systems China Co., Ltd.

CPSC Moderate May 1, 2025

Baseus Portable Chargers Recalled Due to Fire Hazard; Sold on Amazon.com by Shenzhen Baseus Technology

CPSC Moderate May 1, 2025

Santa Cruz Bicycles Recalls Electric Bicycles Due to Fire Hazard

Santa Cruz Bicycles LLC, of Santa Cruz, California

FDA Food Critical Apr 30, 2025

Walker's Wine Juice Pumpkin Juice 2.5, 5, 30, 60, 275 gallon bulk containers

Walker's Fruit Basket and Press House

FDA Drug Moderate Apr 30, 2025

Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 7144…

Denver Solutions, LLC DBA Leiters Health

FDA Drug Moderate Apr 30, 2025

dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 1379…

Denver Solutions, LLC DBA Leiters Health

FDA Drug Moderate Apr 30, 2025

Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11

Denver Solutions, LLC DBA Leiters Health

FDA Drug Moderate Apr 30, 2025

Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11

Denver Solutions, LLC DBA Leiters Health

FDA Drug Moderate Apr 30, 2025

PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englew…

Denver Solutions, LLC DBA Leiters Health

FDA Devices Moderate Apr 30, 2025

Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080

Abbott

FDA Devices Moderate Apr 30, 2025

Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly

Merit Medical Systems, Inc.

FDA Devices Moderate Apr 30, 2025

Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description:…

Abbott Laboratories

FDA Devices Moderate Apr 30, 2025

InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA

Medtronic MiniMed, Inc.

FDA Devices Moderate Apr 30, 2025

Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical pr…

Philips North America Llc

FDA Devices Moderate Apr 30, 2025

Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount

IHB OPERATIONS B.V.

FDA Devices Moderate Apr 30, 2025

Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environmen…

Philips Medical Systems Nederland B.V.

FDA Devices Moderate Apr 30, 2025

Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical…

Philips North America Llc

FDA Devices Moderate Apr 30, 2025

The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and …

Abbott Molecular, Inc.

FDA Devices Moderate Apr 30, 2025

Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ceme…

Zimmer, Inc.

FDA Devices Critical Apr 30, 2025

Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Dia…

Conavi Medical Inc.

FDA Devices Moderate Apr 30, 2025

Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical p…

Philips North America Llc

FDA Devices Moderate Apr 30, 2025

Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

Philips North America Llc

FDA Devices Moderate Apr 30, 2025

The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended length endoscope. The Harvesting…

Maquet Cardiovascular, LLC

FDA Devices Moderate Apr 30, 2025

Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product Description:…

Abbott Laboratories

FDA Devices Moderate Apr 30, 2025

Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer,…

Zimmer, Inc.

FDA Devices Moderate Apr 30, 2025

Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Description:…

Abbott Laboratories

FDA Devices Moderate Apr 30, 2025

Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly

Merit Medical Systems, Inc.

FDA Devices Moderate Apr 30, 2025

Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080

Abbott

FDA Devices Moderate Apr 30, 2025

Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092 …

Radiometer Medical ApS

FDA Devices Moderate Apr 30, 2025

Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer,…

Zimmer, Inc.

FDA Devices Moderate Apr 30, 2025

MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;

Globus Medical, Inc.