FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 36 of 520
Moderate Mar 26, 2025
CYSTO PACK , Model N. HKCY31A
American Contract Systems Inc
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
Moderate Mar 26, 2025
BORN ON ARRIVAL KIT , Model No LLBN11B
American Contract Systems Inc
Moderate Mar 26, 2025
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Smiths Medical ASD, Inc.
Moderate Mar 26, 2025
URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
American Contract Systems Inc
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)
Moderate Mar 26, 2025
GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
American Contract Systems Inc
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.
Moderate Mar 26, 2025
C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
American Contract Systems Inc
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
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.
Moderate Mar 26, 2025
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
Smiths Medical ASD, Inc.
Moderate Mar 26, 2025
AV FISTULA , Model No UTAV77T
American Contract Systems Inc
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.
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.
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.
Moderate Mar 26, 2025
Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
MEDLINE INDUSTRIES, LP - Northfield
Moderate Mar 26, 2025
THORACIC PACK , Model No UTTC82Y UTTC82AA-01
American Contract Systems Inc
Moderate Mar 26, 2025
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278
Beckman Coulter, Inc.
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.
Moderate Mar 26, 2025
Access 2 Immunoassay Analyzer, Catalog Number 81600N
Beckman Coulter, Inc.
Moderate Mar 26, 2025
Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
MEDLINE INDUSTRIES, LP - Northfield
Moderate Mar 26, 2025
OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
American Contract Systems Inc
Moderate Mar 19, 2025
Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
Stryker Corporation
Critical Mar 19, 2025
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. …
Medtronic Perfusion Systems
Moderate Mar 19, 2025
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Description: The Powerheart G5 autom…
ZOLL Medical Corporation
Moderate Mar 19, 2025
CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an Electrophy…
CardioFocus, Inc.
Moderate Mar 19, 2025
Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952R, Negus Tonsil Forceps X-HVY-…
Aesculap Inc
Moderate Mar 19, 2025
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C…
ZOLL Medical Corporation
Critical Mar 19, 2025
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
CareFusion 303, Inc.
Moderate Mar 19, 2025
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
Beckman Coulter, Inc.
Moderate Mar 19, 2025
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Philips Medical Systems Nederland B.V.
Moderate Mar 19, 2025
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; Software Version: NA P…
ZOLL Medical Corporation
Moderate Mar 19, 2025
Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of in…
Cordis US Corp
Moderate Mar 19, 2025
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S…
ZOLL Medical Corporation
Moderate Mar 19, 2025
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6) G5A-80A…
ZOLL Medical Corporation
Moderate Mar 19, 2025
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version: NA Product Description: Th…
ZOLL Medical Corporation
Moderate Mar 19, 2025
Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software Version: N/A
TruAbutment Inc.
Moderate Mar 19, 2025
Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJ501R, Phaneuf Hysterectomy Fo…
Aesculap Inc
Moderate Mar 19, 2025
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
GE Medical Systems, LLC
Critical Mar 19, 2025
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/…
Smiths Medical ASD, Inc.
Moderate Mar 19, 2025
Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps 85MM; (2) REF BH104R, Hartmann Mosquito FCSDEL STR 100MM; …
Aesculap Inc
Moderate Mar 19, 2025
GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed
GE Medical Systems, LLC
Moderate Mar 19, 2025
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to H…
Intuitive Surgical, Inc.
Moderate Mar 19, 2025
GE Healthcare Revolution CT, System, X-ray, Tomography, Computed
GE Medical Systems, LLC
Moderate Mar 19, 2025
Z1 Femoral Hip System, Product Number 611777612
Zimmer, Inc.
Moderate Mar 19, 2025
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80C, (2) G5A-80C-TSO. Software Version: NA Product Description: Th…
ZOLL Medical Corporation
Moderate Mar 12, 2025
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
HUMAN MED AG
Moderate Mar 12, 2025
MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
Medtronic MiniMed, Inc.
Moderate Mar 12, 2025
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): …
Integra LifeSciences Corp.