Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 117 of 548
FDA Devices Moderate Jun 14, 2023
The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antig…
BioReference Health, LLC
FDA Devices Critical Jun 14, 2023
Trilogy Evo Universal Ventilator, Model Number DS2000X11B
Philips Respironics, Inc.
FDA Drug Moderate Jun 7, 2023
HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles A…
SSM Health Care St. Louis DBA SSM St. Clare Health Center
FDA Devices Moderate Jun 7, 2023
Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; …
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Jun 7, 2023
Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Ster…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Jun 7, 2023
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA …
Maquet Medical Systems USA
FDA Devices Moderate Jun 7, 2023
LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee…
Linkbio Corp.
FDA Devices Moderate Jun 7, 2023
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 701067905 HM…
Maquet Medical Systems USA
FDA Devices Moderate Jun 7, 2023
Intelli-C, Left side suspended Tabletop, REF: 03400010
NRT X-RAY A/S
FDA Devices Moderate Jun 7, 2023
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA …
Maquet Medical Systems USA
FDA Devices Moderate Jun 7, 2023
CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and¿three-dimensional¿digital¿X-ray¿images¿of¿the¿dento-maxilofacial,¿ENT¿(Ear,¿No…
Trophy SAS
FDA Devices Moderate Jun 7, 2023
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
Elekta, Inc.
FDA Devices Moderate Jun 7, 2023
TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E
Howmedica Osteonics Corp.
FDA Devices Moderate Jun 7, 2023
Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4)…
Smith & Nephew, Inc.
FDA Devices Moderate Jun 7, 2023
BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905
Maquet Medical Systems USA
FDA Devices Moderate Jun 7, 2023
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA 701070412 HMO 11000-USA …
Maquet Medical Systems USA
FDA Devices Moderate Jun 7, 2023
Intelli-C, Right side suspended Tabletop, REF: 03400000
NRT X-RAY A/S
FDA Devices Moderate Jun 7, 2023
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA …
Maquet Medical Systems USA
FDA Devices Moderate Jun 7, 2023
Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZE 1 Right Medial); b) REF 1…
Smith & Nephew, Inc.
FDA Devices Moderate Jun 7, 2023
QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701067840 BEQ-H…
Maquet Medical Systems USA
FDA Devices Moderate Jun 7, 2023
QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA …
Maquet Medical Systems USA
FDA Devices Moderate Jun 7, 2023
TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
Howmedica Osteonics Corp.
FDA Devices Moderate Jun 7, 2023
VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 621…
Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Jun 7, 2023
BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
Maquet Medical Systems USA
FDA Devices Moderate Jun 7, 2023
Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL; b) REF 1-10012-150, …
Smith & Nephew, Inc.
FDA Devices Moderate Jun 7, 2023
EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
Philips North America Llc
FDA Devices Moderate Jun 7, 2023
EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380
Philips North America Llc
FDA Devices Moderate Jun 7, 2023
QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 …
Maquet Medical Systems USA
FDA Devices Moderate Jun 7, 2023
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 70000-USA 701067820 HMO 71000-USA …
Maquet Medical Systems USA
FDA Devices Moderate Jun 7, 2023
Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation
TELEFLEX LLC
FDA Food Moderate May 31, 2023
Country Cookie Pumpkin Bar, plastic clamshell
Country Cookie LLC.
FDA Drug Moderate May 31, 2023
tromethamine 0.3 Molar, 50 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 712…
Central Admixture Pharmacy Services, Inc.
FDA Drug Moderate May 31, 2023
Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road,…
Central Admixture Pharmacy Services, Inc.
FDA Devices Moderate May 31, 2023
Luminos Agile Max (VE10, VF10, VF11)
Siemens Medical Solutions USA, Inc
FDA Devices Critical May 31, 2023
EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood p…
BERLIN HEART GMBH
FDA Devices Critical May 31, 2023
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
SD Biosensor, Inc.
FDA Devices Moderate May 31, 2023
Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
PHILIPS HEADQUARTERS CAMBRIDGE
FDA Devices Low May 31, 2023
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal …
Olympus Corporation of the Americas
FDA Devices Moderate May 31, 2023
VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemog…
Ortho-Clinical Diagnostics, Inc.
FDA Devices Low May 31, 2023
To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial…
Olympus Corporation of the Americas
FDA Devices Moderate May 31, 2023
Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Windstone Medical Packaging, Inc.
FDA Devices Moderate May 31, 2023
Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibrating the Acet, …
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 31, 2023
Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)
PHILIPS HEADQUARTERS CAMBRIDGE
FDA Devices Moderate May 31, 2023
Luminos dRF Max (VE10, VF10, VF11)
Siemens Medical Solutions USA, Inc
FDA Devices Moderate May 31, 2023
Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
PHILIPS HEADQUARTERS CAMBRIDGE
FDA Devices Moderate May 31, 2023
Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
OmniCell, Inc.
FDA Devices Moderate May 31, 2023
ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salic…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 31, 2023
Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)
PHILIPS HEADQUARTERS CAMBRIDGE
FDA Drug Moderate May 24, 2023
FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-910-25
Apollo Care, LLC
FDA Devices Moderate May 24, 2023
REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
Stryker Sustainability Solutions