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High RiskFDA
Sophysa S.a.
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pres...
Medical Devices·3,175 affected·Apr 9, 2024
High RiskFDA
Sophysa S.a.
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pres...
Medical Devices·3,487 affected·Apr 9, 2024
High RiskFDA
Ge Medical Systems Information Technologies Inc
GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, 20/...
Medical Devices·23,180 affected·Apr 9, 2024
High RiskFDA
Quidelortho
VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measurement of free t...
Diagnostic Devices·0 affected·Apr 9, 2024
High RiskFDA
Home Style Foods, Inc.
Kowalski Simply Sides - Jack's Potato Salad, 16oz. plastic tub, UPC: 754721282701. 6 retail tubs per wholesale case.
Produce·43 affected·Apr 8, 2024
High RiskFDA
Taylor Farms Southwest, Inc
Ready Meals Teriyaki Salmon W Rice 13.5OZ TRAY BLK&GOLD ALUM 22OZ with Plastic Lid #81061425 UPC: 002113010092 Sell Thru 04/12/24 LOT TF...
Seafood·148 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedural kits labeled as: ARTHROGRAPH TRAY, Pack Number MNS12670A
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAPH TRAY, Pack Name MNS12670A; 2) BREAST BIOPSY KIT, Pac...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
see RES for description
Medical Devices·1,679,067 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327F; 2) ANESTHESIA CIRCUIT PEDS-LF, Pack Numb...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS12670A; 3) CIRC...
Surgical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, Pack Number 59112; 2) SUTURE SET, Pack Number DYNDL1984; ...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALY...
Medical Devices·1,679,067 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ; 2) KIT LEFT HEART-VA MED, Pack Number 132...
Cardiac Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS830039AD; 2) FETAL SURGERY CDS-LF, Pack Number CDS840214P...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981050Q; 2) OPEN HEART CDS, Pack Number CDS982411N; 3) OPEN...
Cardiac Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion procedure kits labeled as: 1) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 2) 5FR 2L PICC LINE TRAY, Pack Number P...
Cardiac Devices·0 affected·Apr 8, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary s...
Respiratory Devices·88 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 2) BRANSON SUPPLEMENTAL PACK , Pack Number DYNDA3019; 3...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedural kits labeled as: PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040H
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedure packs containing Shenli syringes, labeled as follows: 1) NEURO ANGIO PACK, Part Number DYNDA1431A; 2) CVC INSERT B...
Medical Devices·1,679,067 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion procedure packs, containing Caina syringes, labeled as: 1) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 2) RET...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS930092U ; 2) SMALL WOUND TRAY, Pack Number DYNDA1822; 3) RAD...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J ; 2) UROLOGY MINOR CDS , Pack Number CDS980371K ;...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) STEREOTACTIC BREAST BIOPSY TRA, Pack Number BT1095 ; 2) BREAST BIOPSY TRAY, Pack Number MNS5...
Diagnostic Devices·0 affected·Apr 8, 2024
High RiskFDA
Heartsine Technologies Ltd
HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
Cardiac Devices·183,248 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack Number DYNJ32049...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) CYSTO PACK, Pack Number DYNJ42742D; 2) CYSTO PACK, Pack Number DYNJ42799
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM, Pack Number DYNDH1446A; 2) ARTHROGRAM TRAY, Pack N...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) TRACHEOSTOMY, Pack Number DYNJ45495G ; 3) TRA...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS981579O ; 2) DR DIULUS INJECTION PACK, Pack Number DYNDA2391...
Medical Devices·1,679,067 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2) CVC INSERTION PACK, Pack Number CVI4720AH; 3...
Surgical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion procedure packs, labeled as: 1) BIOPSY TRAY-LF, Pack Number SPEC4380; 2) CIRCUMCISION TRAY, Pack Number CIT6325; 3) CIRC...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pack Number DYNJ0233...
Cardiac Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion procedure kits labeled as: 1) BONE MARROW TRAY, Pack Number SPEC0255; 2) CT/ULTRASOUND BIOPSY, Pack Number SPEC0262; 3) ...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) VANTEX 7...
Medical Devices·1,679,067 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion procedure packs, containing Caina syringes, labeled as: 1) BREAST BIOPSY KIT, Pack Number DYNDH1512A; 2) CIRCUMCISION KIT...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) OR CLEAN UP KIT, Pack Number DYK1002355X3, 2) CLEANING & CUTTING, Pack Number DYNJ84657
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) PSP - VAMC LONG BEACH, Pack Number 146255; 2) INSERTION TRAY, Pack Number CVI5080; 3) INCI...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: HSG TRAY, Pack Number DYNDH1453
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: ADMIT KIT PILLOW BOX, Pack Number DYKA1389
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedural kits labeled as: 1) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack N...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
See RES Description
Medical Devices·1,679,067 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAP...
Surgical Devices·1,679,067 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S; 2) MAJOR EAR , Pack Number CDS982016T; 3) MAJOR EAR...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) ARTERIAL LINE TRAY-NO CATHETER, ...
Surgical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion procedure kits labeled as: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; 2) ARTHROSCOPY TRAY, Pack Number AM11...
Medical Devices·0 affected·Apr 8, 2024