Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 58 of 548
FDA Devices Moderate Sep 25, 2024
Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract.
Boston Scientific Corporation
FDA Devices Moderate Sep 25, 2024
HAWK Advanced Hypothermia Management Set, Item Number: 59-320
Safeguard US Operating LLC
FDA Devices Moderate Sep 25, 2024
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
CareFusion 303, Inc.
FDA Devices Moderate Sep 25, 2024
HAWK Warming Grid, Item Number: 59-300
Safeguard US Operating LLC
FDA Devices Moderate Sep 25, 2024
Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Sep 25, 2024
vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a percutaneously placed drain for…
Boston Scientific Corporation
FDA Devices Moderate Sep 25, 2024
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Numb…
B Braun Medical Inc
FDA Devices Moderate Sep 25, 2024
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Numb…
B Braun Medical Inc
FDA Devices Moderate Sep 25, 2024
TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabi…
Innovasis, Inc
FDA Devices Moderate Sep 25, 2024
STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog …
B Braun Medical Inc
FDA Devices Moderate Sep 25, 2024
System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion 7 M12 72222…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Sep 25, 2024
STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095W
B Braun Medical Inc
FDA Devices Moderate Sep 25, 2024
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
Tornier, Inc
FDA Devices Moderate Sep 25, 2024
VariSoft Infusion Set, Single Use.
Unomedical A/S
FDA Devices Moderate Sep 25, 2024
Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK Warming Grid, 2. Item Number: 59-320 HAWK Advanced Hypothe…
Safeguard US Operating LLC
FDA Devices Moderate Sep 25, 2024
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
CareFusion 303, Inc.
FDA Devices Moderate Sep 25, 2024
Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
CareFusion 303, Inc.
FDA Devices Moderate Sep 25, 2024
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging…
GE Healthcare GmbH
FDA Devices Moderate Sep 25, 2024
2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Produc…
Medtronic Inc.
FDA Devices Critical Sep 25, 2024
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
Baxter Healthcare Corporation
FDA Devices Moderate Sep 25, 2024
Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry sys…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Sep 25, 2024
Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and an…
SEER MEDICAL PTY LTD
FDA Devices Critical Sep 25, 2024
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
Baxter Healthcare Corporation
FDA Devices Moderate Sep 25, 2024
System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Sep 25, 2024
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrume…
Beckman Coulter, Inc.
FDA Devices Moderate Sep 25, 2024
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
ROi CPS LLC
FDA Devices Moderate Sep 25, 2024
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
Cypress Medical Products LLC
FDA Devices Moderate Sep 25, 2024
ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistr…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Sep 25, 2024
Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail
Boston Scientific Corporation
FDA Devices Moderate Sep 25, 2024
Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008
Cypress Medical Products LLC
FDA Devices Moderate Sep 25, 2024
System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/20 OR Table 722038 Allura Xper FD20/20 722035 All…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Sep 25, 2024
System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDiagnost Eleva 708034 MultiDiagn…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Sep 25, 2024
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
Smith & Nephew, Inc.
FDA Devices Moderate Sep 25, 2024
Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
Btt Health Gmbh
CPSC Moderate Sep 19, 2024
Polaris Recalls Sportsman All-Terrain Vehicles Due to Fire Hazard
Polaris Industries Inc., of Medina, Minnesota
FDA Drug Low Sep 18, 2024
Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with im…
Elevate Oral Care
FDA Devices Moderate Sep 18, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ59921B; b) AMB VITRECTOMY, …
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Sep 18, 2024
Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using th…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Sep 18, 2024
Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular…
Zimmer GmbH
FDA Devices Moderate Sep 18, 2024
Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW Version 4.0.1.15 or lower. …
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Sep 18, 2024
Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Sep 18, 2024
Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SOL-M 20ml Ecc…
Sol-Millennium Medical Inc.
FDA Devices Moderate Sep 18, 2024
Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, Pack Number 59112; 2) SUTURE SET, Pack Number DYNDL1984; 3) CLOSING …
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Sep 18, 2024
25-LHP-928, HeNe Laser System, 25 mW
PACIFIC LASERTECH, LLC
FDA Devices Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ; 2) KIT LEFT HEART-VA MED, Pack Number 132701; 3) KI…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS830039AD; 2) FETAL SURGERY CDS-LF, Pack Number CDS840214P ; 3) OB PR…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Sep 18, 2024
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Sep 18, 2024
N-LHP-928, HeNe Laser System, 35 mW
PACIFIC LASERTECH, LLC
FDA Devices Moderate Sep 18, 2024
Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Sep 18, 2024
IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12…
Ion Beam Applications S.A.