PlainRecalls

Medical Devices Recalls

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

27,372 recalls · Page 37 of 548

FDA Devices Moderate Mar 26, 2025

VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information syst…

Merge Healthcare, Inc.

FDA Devices Moderate Mar 26, 2025

DIAGNOSTIC NEURO IR TRAY , Model No WENE21

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

DELIVERY PACK , Model No SGDV22D-01 SGDV22E

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric, PT00156254 …

Oridion Medical 1987 Ltd.

FDA Devices Moderate Mar 26, 2025

VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integr…

Merge Healthcare, Inc.

FDA Devices Moderate Mar 26, 2025

OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I

American Contract Systems Inc

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introd…

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

LAPAROSCOPY PACK , Model No SFLA02A SFLA02B

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

CYSTO , Model No SACY80R

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Car…

Merge Healthcare, Inc.

FDA Devices Moderate Mar 26, 2025

DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.

American Contract Systems Inc

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-…

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information …

Merge Healthcare, Inc.

FDA Devices Moderate Mar 26, 2025

Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in t…

Immuno-Mycologics, Inc

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introd…

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - OmniVentLine Set Adult-Pedi…

Oridion Medical 1987 Ltd.

FDA Devices Moderate Mar 26, 2025

Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 26, 2025

Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11

Waldemar Link GmbH & Co. KG (Mfg Site)

FDA Devices Moderate Mar 26, 2025

VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - …

Oridion Medical 1987 Ltd.

FDA Devices Moderate Mar 26, 2025

Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. Sterile surg…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 26, 2025

Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0…

Microbiologics Inc

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

CYSTO PACK , Model N. HKCY31A

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 11…

ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY

FDA Devices Moderate Mar 26, 2025

BORN ON ARRIVAL KIT , Model No LLBN11B

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13

Waldemar Link GmbH & Co. KG (Mfg Site)

FDA Devices Moderate Mar 26, 2025

GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03

American Contract Systems Inc

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1

Brainlab AG

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

AV FISTULA , Model No UTAV77T

American Contract Systems Inc

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 - Micros…

Oridion Medical 1987 Ltd.

FDA Devices Moderate Mar 26, 2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediatric Intubated, PT00134333 - …

Oridion Medical 1987 Ltd.

FDA Devices Moderate Mar 26, 2025

Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 26, 2025

THORACIC PACK , Model No UTTC82Y UTTC82AA-01

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278

Beckman Coulter, Inc.

FDA Devices Moderate Mar 26, 2025

BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Deskt…

CareFusion 303, Inc.

FDA Devices Moderate Mar 26, 2025

Access 2 Immunoassay Analyzer, Catalog Number 81600N

Beckman Coulter, Inc.

FDA Devices Moderate Mar 26, 2025

Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 26, 2025

OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02

American Contract Systems Inc