PlainRecalls

Medical Devices Recalls

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

27,372 recalls · Page 43 of 548

FDA Devices Moderate Jan 29, 2025

BD Pyxis MedStation 4000 AUX, REF 306

CareFusion 303, Inc.

CPSC Moderate Jan 23, 2025

SHEIN Distribution Corporation Recalls Teckwe Hair Dryer Brushes Due to Electrocution or Shock Hazard

SHEIN Distribution Corporation, of Los Angeles, California

FDA Devices Critical Jan 22, 2025

PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model N…

Boston Scientific Corporation

FDA Devices Critical Jan 22, 2025

Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002

Baxter Healthcare Corporation

FDA Devices Moderate Jan 22, 2025

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-…

Augustine Temperature Management, LLC

FDA Devices Moderate Jan 22, 2025

8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB632…

Coloplast Manufacturing US, LLC

FDA Devices Moderate Jan 22, 2025

8MM,MEGA SUTURECUT ND,IS4000 REF 471309

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DIL…

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

8MM,PROGRASP FORCEPS,IS4000 REF 471093

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630; 2) ECONO STERILE BACKHAU…

Sklar Instruments

FDA Devices Critical Jan 22, 2025

Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the inst…

Olympus Corporation of the Americas

FDA Devices Moderate Jan 22, 2025

Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and

Cook Biotech, Inc.

FDA Devices Moderate Jan 22, 2025

Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.

Hologic, Inc.

FDA Devices Moderate Jan 22, 2025

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refu…

Augustine Temperature Management, LLC

FDA Devices Moderate Jan 22, 2025

Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N

SIN SISTEMA DE IMPLANTE NACIONAL S.A

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179

Intuitive Surgical, Inc.

FDA Devices Critical Jan 22, 2025

Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.

Trokamed GmbH

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; 2) ECONO STERILE DRESSING FCP…

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246

Intuitive Surgical, Inc.

FDA Devices Critical Jan 22, 2025

Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,ANGIO,DOUBLE,SPIKE,KIT,KENNED…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jan 22, 2025

8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205

Intuitive Surgical, Inc.

FDA Devices Critical Jan 22, 2025

Impella RP Flex with SmartAssist; Product Number: 1000323;

Abiomed, Inc.

FDA Devices Moderate Jan 22, 2025

8MM,LONG TIP FORCEPS,IS4000 REF 471048

Intuitive Surgical, Inc.

FDA Devices Critical Jan 22, 2025

nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquade…

Nuwellis Inc

FDA Devices Moderate Jan 22, 2025

Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM3; 3 ) ANEURYSM PACK …

Cardinal Health 200, LLC

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK …

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D delivery c…

Alcon Research LLC

FDA Devices Moderate Jan 22, 2025

GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Jan 22, 2025

Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH1; 3) KIT,H N …

Cardinal Health 200, LLC

FDA Devices Moderate Jan 22, 2025

GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Jan 22, 2025

8MM,RESANO FORCEPS,IS4000 ¿ REF 470181

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA N…

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814; eyelid surgery

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H3100BT; 5) H3100PX; System, T…

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Jan 22, 2025

Change Healthcare Cardiology Hemo software

A L I Technologies Ltd

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUE…

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5 3 ) KIT, FETAL …

Cardinal Health 200, LLC

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A; 2) ECONO STERILE HALSE…

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC42; 3) CHI S…

Cardinal Health 200, LLC

FDA Devices Critical Jan 22, 2025

Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.

Trokamed GmbH

FDA Devices Moderate Jan 22, 2025

NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX

NOA Medical Industries Inc

FDA Devices Moderate Jan 22, 2025

GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Critical Jan 22, 2025

VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)

Boston Scientific Corporation

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A, gynecological procedures

Sklar Instruments