FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 35 of 520
Moderate Apr 2, 2025
Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D; 2) CSMC/GYN LAPAROSCOPIC PACK-LF, Pack Number DYNJ0665103I; 3…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Apr 2, 2025
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catal…
Microbiologics Inc
Moderate Apr 2, 2025
Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2) DELIVERY PACK-LF, Pack Number DYNJ0968863M; 3) L & D PACK-LF,…
MEDLINE INDUSTRIES, LP - Northfield
Critical Apr 2, 2025
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Covidien
Moderate Apr 2, 2025
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Premier Dental Products Co
Moderate Apr 2, 2025
Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2) ARTHROSCOPY PACK-LF, Pack Number DYNJ0390808F; 3) ARTHROSC…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Apr 2, 2025
Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small Model/Catalog Number: REF# 9524 (S…
Checkpoint Surgical Inc
Moderate Apr 2, 2025
Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 40…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Apr 2, 2025
Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS
Baxter Healthcare Corporation
Moderate Mar 26, 2025
MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
American Contract Systems Inc
Moderate Mar 26, 2025
Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 101294…
Oridion Medical 1987 Ltd.
Moderate Mar 26, 2025
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Infant, PT00156250 - Mic…
Oridion Medical 1987 Ltd.
Moderate Mar 26, 2025
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 -…
Oridion Medical 1987 Ltd.
Moderate Mar 26, 2025
LABOR & DELIVERY PACK, Model Nos LLLD19H
American Contract Systems Inc
Moderate Mar 26, 2025
Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampling Line, 01158 - Microstr…
Oridion Medical 1987 Ltd.
Moderate Mar 26, 2025
CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
American Contract Systems Inc
Moderate Mar 26, 2025
Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DR…
MEDLINE INDUSTRIES, LP - Northfield
Critical Mar 26, 2025
smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
Smiths Medical ASD, Inc.
Moderate Mar 26, 2025
GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
American Contract Systems Inc
Moderate Mar 26, 2025
C-SECTION PACK, Model Nos LLCS44F LLCS44F-01
American Contract Systems Inc
Moderate Mar 26, 2025
Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV40…
Remel, Inc
Critical Mar 26, 2025
smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-…
Smiths Medical ASD, Inc.
Moderate Mar 26, 2025
Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.
MEDLINE INDUSTRIES, LP - Northfield
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.
Moderate Mar 26, 2025
DIAGNOSTIC NEURO IR TRAY , Model No WENE21
American Contract Systems Inc
Moderate Mar 26, 2025
DELIVERY PACK , Model No SGDV22D-01 SGDV22E
American Contract Systems Inc
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.
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.
Moderate Mar 26, 2025
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
American Contract Systems Inc
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.
Moderate Mar 26, 2025
HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
American Contract Systems Inc
Moderate Mar 26, 2025
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
American Contract Systems Inc
Moderate Mar 26, 2025
LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
American Contract Systems Inc
Moderate Mar 26, 2025
CYSTO , Model No SACY80R
American Contract Systems Inc
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.
Moderate Mar 26, 2025
DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
American Contract Systems Inc
Moderate Mar 26, 2025
LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
American Contract Systems Inc
Moderate Mar 26, 2025
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
American Contract Systems Inc
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.
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.
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
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.
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.
Moderate Mar 26, 2025
Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
MEDLINE INDUSTRIES, LP - Northfield
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)
Moderate Mar 26, 2025
VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
American Contract Systems Inc
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.
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
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
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.