FDA Medical Devices

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

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

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

Belmont Instrument LLC

Enhanced Verify Evaluation Handset (CFN HH90130FA)

Medtronic Neuromodulation

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

Defibtech, LLC

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)

Critical May 7, 2025

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

GE Medical Systems China Co., Ltd.

Critical May 7, 2025

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

GE Medical Systems China Co., Ltd.

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

Abbott

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

Merit Medical Systems, Inc.

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

Abbott Laboratories

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

Medtronic MiniMed, Inc.

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

Philips North America Llc

Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount

IHB OPERATIONS B.V.

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.

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

Philips North America Llc

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.

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.

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.

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

Philips North America Llc

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

Philips North America Llc

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

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

Abbott Laboratories

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.

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

Abbott Laboratories

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

Merit Medical Systems, Inc.

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

Abbott

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

Radiometer Medical ApS

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.

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

Globus Medical, Inc.

Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Description:…

Abbott Laboratories

Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A;

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Descripti…

Abbott Diagnostics Scarborough, Inc.

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard Tu…

Avanos Medical, Inc.

t:slim X2 Insulin Pump with Interoperable Technology

Tandem Diabetes Care, Inc.

Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A; 2) C-SECTION PCH-LF, Model Number: DYNJ…

MEDLINE INDUSTRIES, LP - Northfield

Welch Allyn Connex Vital Signs Monitor (CVSM):

Baxter Healthcare Corporation

Refer to RES

MEDLINE INDUSTRIES, LP - Northfield

Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B

MEDLINE INDUSTRIES, LP - Northfield

Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A; 2) TRAY ADD A CATH FOL UM MF 10ML, Model Number:…

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Su…

Avanos Medical, Inc.

Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Product Code/Part # 67MXTX-B; …

Baxter Healthcare Corporation

Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus pa…

Abbott Diagnostics Scarborough, Inc.

Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74CX-B; 5) 74ME-B; 6) 74MT-…

Baxter Healthcare Corporation

Welch Allyn CONNEX Accessory Power Management Stand:

Baxter Healthcare Corporation

Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Aneroid Gauge Sets with a Reusab…

Baxter Healthcare Corporation

Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Ballard Closed …

Avanos Medical, Inc.

Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAGINAL DELIVERY PACK-LF, Model …

MEDLINE INDUSTRIES, LP - Northfield