Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 96 of 548
FDA Devices Moderate Dec 13, 2023
PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
Heartware, Inc.
FDA Devices Critical Dec 13, 2023
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
Maquet Medical Systems USA
FDA Devices Moderate Dec 13, 2023
ProCuity bed series, model number 3009, item number: 3009PX-LE-450.
Stryker Medical Division of Stryker Corporation
FDA Devices Moderate Dec 13, 2023
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
Staar Surgical Company
FDA Devices Moderate Dec 13, 2023
ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450.
Stryker Medical Division of Stryker Corporation
FDA Devices Moderate Dec 6, 2023
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
Aizu Olympus Co., Ltd.
FDA Devices Moderate Dec 6, 2023
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Intuitive Surgical, Inc.
FDA Devices Moderate Dec 6, 2023
SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
PATH
FDA Devices Moderate Dec 6, 2023
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
Medtronic Inc.
FDA Devices Moderate Dec 6, 2023
with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended …
Breas Medical, Inc.
FDA Devices Moderate Dec 6, 2023
Lugol s Iodine Solution 500ML, Part Number 624-71
EMD Millipore Corporation
FDA Devices Moderate Dec 6, 2023
RAPIDPOINT 500 Blood Gas System
Siemens Healthcare Diagnostics Inc
FDA Devices Moderate Dec 6, 2023
SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
PATH
FDA Devices Moderate Dec 6, 2023
SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
PATH
FDA Devices Moderate Dec 6, 2023
PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
Aizu Olympus Co., Ltd.
FDA Devices Moderate Dec 6, 2023
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
Aizu Olympus Co., Ltd.
FDA Devices Moderate Dec 6, 2023
BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Becton Dickinson Infusion Therapy Systems Inc.
FDA Devices Moderate Dec 6, 2023
RAPIDPOINT 500e Blood Gas System
Siemens Healthcare Diagnostics Inc
FDA Devices Moderate Dec 6, 2023
GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Aizu Olympus Co., Ltd.
FDA Devices Moderate Nov 29, 2023
Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Numb…
Biomet, Inc.
FDA Devices Moderate Nov 29, 2023
Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Numb…
Biomet, Inc.
FDA Devices Moderate Nov 29, 2023
Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Numb…
Biomet, Inc.
FDA Devices Critical Nov 29, 2023
VariSoft infusion set, Model Number 1002828
Unomedical A/S
FDA Devices Moderate Nov 29, 2023
stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Sage Products Inc
FDA Devices Moderate Nov 29, 2023
Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Numb…
Aizu Olympus Co., Ltd.
FDA Devices Moderate Nov 29, 2023
Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. M…
Aizu Olympus Co., Ltd.
FDA Devices Moderate Nov 29, 2023
Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Numb…
Biomet, Inc.
FDA Devices Moderate Nov 29, 2023
Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resuscitator REF #s: CPRM1116FPM, …
SunMed Holdings, LLC
FDA Devices Moderate Nov 29, 2023
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
Instrumentation Laboratory
FDA Devices Moderate Nov 29, 2023
Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult Resusc…
SunMed Holdings, LLC
FDA Devices Moderate Nov 29, 2023
Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numb…
Aizu Olympus Co., Ltd.
FDA Devices Moderate Nov 29, 2023
EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
Boston Scientific Corporation
FDA Devices Moderate Nov 29, 2023
Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item …
Biomet, Inc.
FDA Devices Moderate Nov 29, 2023
Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item …
Biomet, Inc.
FDA Devices Low Nov 29, 2023
Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
Aizu Olympus Co., Ltd.
FDA Devices Moderate Nov 29, 2023
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
Medtronic Inc
FDA Devices Moderate Nov 29, 2023
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ…
Aizu Olympus Co., Ltd.
FDA Devices Moderate Nov 29, 2023
Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). Model …
Aizu Olympus Co., Ltd.
FDA Devices Moderate Nov 29, 2023
Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Numb…
Biomet, Inc.
FDA Devices Moderate Nov 29, 2023
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
Medtronic Inc
FDA Devices Moderate Nov 29, 2023
Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Number…
Aizu Olympus Co., Ltd.
FDA Devices Moderate Nov 29, 2023
Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. BreathTech Adult Resuscit…
SunMed Holdings, LLC
FDA Devices Moderate Nov 29, 2023
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
Instrumentation Laboratory
FDA Devices Moderate Nov 29, 2023
Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item …
Biomet, Inc.
FDA Devices Moderate Nov 29, 2023
EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M005…
Boston Scientific Corporation
FDA Devices Moderate Nov 29, 2023
Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item …
Biomet, Inc.
FDA Devices Moderate Nov 29, 2023
Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the ai…
Aizu Olympus Co., Ltd.
FDA Devices Moderate Nov 29, 2023
Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). Model Numbers…
Aizu Olympus Co., Ltd.
FDA Devices Moderate Nov 29, 2023
Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. STAT-Check Adult Resusci…
SunMed Holdings, LLC
FDA Devices Moderate Nov 29, 2023
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
Medtronic Inc