FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 54 of 520
Moderate Oct 16, 2024
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 9, 2024
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Young Dental Manufacturing I, LLC
Critical Oct 9, 2024
MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; Min…
Medtronic MiniMed, Inc.
Moderate Oct 9, 2024
DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
Critical Oct 9, 2024
Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Percussionaire Corporation
Critical Oct 9, 2024
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Percussionaire Corporation
Moderate Oct 9, 2024
Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay i…
Healgen Scientific Llc
Moderate Oct 9, 2024
DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
Alcon Research LLC
Moderate Oct 9, 2024
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients wit…
Outset Medical, Inc.
Moderate Oct 9, 2024
Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyo…
CooperVision, Inc.
Moderate Oct 9, 2024
DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
Moderate Oct 9, 2024
DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
Critical Oct 9, 2024
Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Mercury Enterprises, Inc. dba Mercury Medical
Moderate Oct 9, 2024
BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in a…
CooperVision, Inc.
Moderate Oct 9, 2024
DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 8661…
Philips North America Llc
Moderate Oct 9, 2024
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Tornier, Inc
Moderate Oct 9, 2024
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
Siemens Healthcare Diagnostics, Inc.
Moderate Oct 9, 2024
BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with …
Becton, Dickinson and Company, BD Bio Sciences
Moderate Oct 2, 2024
Pacemaker, COPM11B; Medical convenience kit
American Contract Systems, Inc.
Critical Oct 2, 2024
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Datascope Corp.
Moderate Oct 2, 2024
WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophage…
Boston Scientific Corporation
Moderate Oct 2, 2024
AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaini…
Boston Scientific Corporation
Moderate Oct 2, 2024
Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603
Cook Biotech, Inc.
Moderate Oct 2, 2024
Hand Pack, AKHD97C; Medical convenience kit
American Contract Systems, Inc.
Critical Oct 2, 2024
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Fresenius Kabi USA, LLC
Moderate Oct 2, 2024
WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal …
Boston Scientific Corporation
Moderate Oct 2, 2024
WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal lumi…
Boston Scientific Corporation
Moderate Oct 2, 2024
Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): …
Cook Biotech, Inc.
Moderate Oct 2, 2024
WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intended for maintaining esophageal …
Boston Scientific Corporation
Moderate Oct 2, 2024
BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacter…
Becton Dickinson & Co.
Moderate Oct 2, 2024
(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888266114, Sterile; (b)…
Cardinal Health 200, LLC
Moderate Oct 2, 2024
Vaginal Delivery, ASDV25B; Medical convenience kit
American Contract Systems, Inc.
Moderate Oct 2, 2024
Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1;…
ARROW INTERNATIONAL Inc.
Moderate Oct 2, 2024
WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal lumin…
Boston Scientific Corporation
Moderate Oct 2, 2024
IR Procedure Pack, CEAT19W; Medical convenience kit
American Contract Systems, Inc.
Moderate Oct 2, 2024
WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal …
Boston Scientific Corporation
Moderate Oct 2, 2024
Custom Procedure Kit, REF: K12T-11077
Merit Medical Systems, Inc.
Moderate Oct 2, 2024
WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophagea…
Boston Scientific Corporation
Moderate Oct 2, 2024
Nasal Sinus Pack, MTSN26B; Medical convenience kit
American Contract Systems, Inc.
Moderate Oct 2, 2024
Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the …
Philips North America Llc
Moderate Oct 2, 2024
Stainless Steel Sims Uterine Sound, Part Number 64-601
CooperSurgical, Inc.
Moderate Oct 2, 2024
Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure o…
Philips North America Llc
Moderate Oct 2, 2024
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Centinel Spine, Inc.
Moderate Oct 2, 2024
WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophagea…
Boston Scientific Corporation
Moderate Oct 2, 2024
AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining…
Boston Scientific Corporation
Moderate Oct 2, 2024
GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; 4) M1112198-01047271; 5) M1…
Wipro GE Healthcare Private Ltd.
Moderate Oct 2, 2024
PACEMAKER PACK, SLCV01J; Medical convenience kit
American Contract Systems, Inc.
Moderate Oct 2, 2024
Neuro Vascular, ANKV91A; Medical convenience kit
American Contract Systems, Inc.
Moderate Oct 2, 2024
WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophagea…
Boston Scientific Corporation
Moderate Oct 2, 2024
WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal …
Boston Scientific Corporation