PlainRecalls

Medical Devices Recalls

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

27,372 recalls · Page 41 of 548

FDA Devices Moderate Feb 12, 2025

IntelliVue Patient Monitor MX550. Model Number: 866066

Philips North America Llc

FDA Devices Moderate Feb 12, 2025

Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.

GE Medical Systems, LLC

FDA Devices Moderate Feb 12, 2025

The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (…

Hologic, Inc.

FDA Devices Critical Feb 12, 2025

regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.

ROi CPS LLC

FDA Devices Critical Feb 12, 2025

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled adm…

Fresenius Kabi USA, LLC

FDA Devices Moderate Feb 12, 2025

Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797

Oxoid Limited

FDA Devices Moderate Feb 12, 2025

IntelliVue Patient Monitor MX500. Model Number: 866064

Philips North America Llc

FDA Devices Moderate Feb 12, 2025

Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Feb 12, 2025

Allura CV20 System Code: 722031

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Feb 12, 2025

ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US

Ethicon, LLC

FDA Devices Moderate Feb 12, 2025

Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Feb 12, 2025

AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Feb 12, 2025

Discovery XR656 HD. X-Ray imaging system.

GE Medical Systems, LLC

FDA Devices Moderate Feb 12, 2025

Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK AP125313PK AP135213PK …

US Endodontics, LLC

FDA Devices Moderate Feb 12, 2025

AlluraXperFD20/10 System Code: (1) 722029

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Feb 12, 2025

AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Feb 12, 2025

Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument

Beckman Coulter, Inc.

FDA Devices Moderate Feb 12, 2025

Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 (3) 722233

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Feb 12, 2025

AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Feb 12, 2025

AlluraXperFD20/15 System Code: (1) 722058

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Feb 12, 2025

Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems

Beckman Coulter Inc.

FDA Devices Moderate Feb 12, 2025

Azurion 5 M12 System Code: (1) 722227 (2) 722231

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Feb 12, 2025

AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Feb 12, 2025

Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;

New Medical Technologies Gmbh

FDA Devices Moderate Feb 12, 2025

Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Feb 12, 2025

Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Feb 5, 2025

AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740

Boston Scientific Corporation

FDA Devices Moderate Feb 5, 2025

KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123

Karl Storz Endoscopy

FDA Devices Moderate Feb 5, 2025

KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123

Karl Storz Endoscopy

FDA Devices Critical Feb 5, 2025

Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Feb 5, 2025

KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE

Karl Storz Endoscopy

FDA Devices Moderate Feb 5, 2025

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540

Boston Scientific Corporation

FDA Devices Moderate Feb 5, 2025

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560

Boston Scientific Corporation

FDA Devices Moderate Feb 5, 2025

Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Feb 5, 2025

KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123

Karl Storz Endoscopy

FDA Devices Moderate Feb 5, 2025

KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123

Karl Storz Endoscopy

FDA Devices Moderate Feb 5, 2025

Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Refere…

Medtronic Navigation, Inc.

FDA Devices Moderate Feb 5, 2025

NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10

Zimmer, Inc.

FDA Devices Moderate Feb 5, 2025

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550

Boston Scientific Corporation

FDA Devices Moderate Feb 5, 2025

MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Feb 5, 2025

KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE

Karl Storz Endoscopy

FDA Devices Moderate Feb 5, 2025

CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Feb 5, 2025

CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The Cy…

Accuray Incorporated

FDA Devices Moderate Feb 5, 2025

AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650

Boston Scientific Corporation

FDA Devices Moderate Feb 5, 2025

KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123

Karl Storz Endoscopy

FDA Devices Moderate Feb 5, 2025

BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 ar…

CareFusion 303, Inc.

FDA Devices Moderate Feb 5, 2025

AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670

Boston Scientific Corporation

FDA Devices Moderate Feb 5, 2025

Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and n…

Draeger Medical Systems, Inc.

FDA Devices Moderate Feb 5, 2025

AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680

Boston Scientific Corporation

FDA Devices Moderate Feb 5, 2025

AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640

Boston Scientific Corporation