FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 29 of 520
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY CDS,…
MEDLINE INDUSTRIES, LP - Northfield
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
VIRTUAL INCISION CORPORATION
Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Mozarc Medical US LLC
Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Mozarc Medical US LLC
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Olympus Corporation of the Americas
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
Beckman Coulter, Inc.
Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863…
Silex Medical, LLC
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnosti…
Luminex Corporation
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
Beckman Coulter Mishima K.K.
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
Healthmark Industries Co., Inc.
Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system
Dexcom, Inc.
Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862100.
Silex Medical, LLC
Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Mozarc Medical US LLC
Lazervida 10W diode laser cutter and engraver with Lazervida shield.
Flux Technology Inc.
MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Mozarc Medical US LLC
Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 586…
Silex Medical, LLC
Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
MEDLINE INDUSTRIES, LP - Northfield
Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 58…
Silex Medical, LLC
Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5864…
Silex Medical, LLC
FoundationOne Companion Diagnostic (F1CDx)
Foundation Medicine, Inc.
Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewell HT" Implan…
Prismatik Dentalcraft, Inc.
DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Pro-Med Instruments Gmbh
Apo B Reagent, REF: OSR6143
Beckman Coulter Ireland, Inc.
SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
Mckesson Medical-Surgical Inc. Corporate Office
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 E…
Onkos Surgical, Inc.
ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.
Mckesson Medical-Surgical Inc. Corporate Office
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M…
Onkos Surgical, Inc.
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
Ortho-Clinical Diagnostics, Inc.
ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.
Mckesson Medical-Surgical Inc. Corporate Office
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
BioFire Diagnostics, LLC
ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.
Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.
Mckesson Medical-Surgical Inc. Corporate Office
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120…
Onkos Surgical, Inc.
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Maquet Cardiopulmonary Ag
ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.
Mckesson Medical-Surgical Inc. Corporate Office
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Cardinal Health 200, LLC
ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.
Mckesson Medical-Surgical Inc. Corporate Office
Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system
Ultra Clean Systems, Inc.
ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
Mckesson Medical-Surgical Inc. Corporate Office
HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.
Mckesson Medical-Surgical Inc. Corporate Office
ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.
Mckesson Medical-Surgical Inc. Corporate Office
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Siemens Healthcare Diagnostics, Inc.
ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.
Mckesson Medical-Surgical Inc. Corporate Office
BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.
Mckesson Medical-Surgical Inc. Corporate Office
Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438…
Baxter Healthcare Corporation
ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.
Mckesson Medical-Surgical Inc. Corporate Office
HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.
Mckesson Medical-Surgical Inc. Corporate Office
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
Cardinal Health 200, LLC
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
Siemens Healthcare Diagnostics, Inc.