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High RiskFDA
Universal Meditech Inc.
HealthyWiser UriTest" UTI Test Strips REF 900-UTI
Medical Devices·5,960 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12
Medical Devices·5,025 affected·May 22, 2023
High RiskFDA
Procaps S.a. De C.v.
Bacaolinita Liquid Dietary Supplement With vitamins A and D + B12 8 fl. oz (236 mL) UPC 841548000028 packaged in a bottle inside a cardbo...
Supplements·33,684 affected·May 19, 2023
High RiskFDA
Springworks Farm Inc.
Springworks Organic single cut green leaf lettuce, 4 oz.
Produce·148 affected·May 19, 2023
High RiskFDA
Sagent Pharmaceuticals Inc
Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 2...
Injectable Drugs·370,200 affected·May 19, 2023
High RiskFDA
Sagent Pharmaceuticals Inc
Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10
Injectable Drugs·2,249,980 affected·May 19, 2023
High RiskFDA
Sagent Pharmaceuticals Inc
Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10
Injectable Drugs·2,249,980 affected·May 19, 2023
High RiskFDA
Zimmer, Inc.
NexGen Precoat Stemmed Tibial Plate Size 5
Medical Devices·0 affected·May 19, 2023
High RiskFDA
Qiagen Gmbh
QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients s...
Respiratory Devices·386 affected·May 19, 2023
High RiskFDA
Baxter Healthcare Corporation
NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
Medical Devices·7 affected·May 19, 2023
High RiskFDA
Baxter Healthcare Corporation
Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed
Medical Devices·8 affected·May 19, 2023
High RiskFDA
Qiagen Gmbh
QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing n...
Respiratory Devices·4,155 affected·May 19, 2023
High RiskFDA
Ascensia Diabetes Care Us, Inc.
Contour¿ next GEN Blood Glucose Monitoring System
Diabetes Devices·2,888 affected·May 19, 2023
High RiskFDA
Fire Distributors Plus Llc
EARTH KRATOM TRAINWRECK 150 CAPSULES (UPC: 908193737324) (50 UNITS/CASE) and 300 CAPSULES (UPC: 005821990011) (25 UNITS/CASE). DISTRIBUTE...
Beverages·26,500 affected·May 18, 2023
High RiskFDA
Fire Distributors Plus Llc
EARTH KRATOM RED MAENG DA KRATOM 65 CAPSULES (UPC: 212223242796) (100 UNITS/CASE). DISTRIBUTED BY FIRE WHOLESALE. Ingredients: Mitragyna ...
Beverages·31,600 affected·May 18, 2023
High RiskFDA
Werner Gourmet Meat Snacks, Inc.
Chili Cacahuate Japones, net weight 5 oz (127g), packaged in a soft teal colored plastic pouch with the UPC code 7 09972 80082 2. There ...
Dairy·2,149 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F; b) END...
Surgical Devices·4,644 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214Q; ...
Surgical Devices·770,147 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA ...
Respiratory Devices·0 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-...
Cardiac Devices·172,722 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA ...
Respiratory Devices·1,784 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI45...
Surgical Devices·620 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOINT, Model Number CDS985555S; b) TOTA...
Medical Devices·4,500 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number DYNJ55252C; b) ...
Cardiac Devices·3,740,814 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L
Medical Devices·128 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A
Medical Devices·144 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A
Medical Devices·183,240 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HM...
Respiratory Devices·0 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: BREAST BIOPSY TRAY, Model Number SPEC0130C
Medical Devices·1,240 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH, Model Number 00-4...
Cardiac Devices·55,014 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC INFANT INSERTION PACK, Model Number CVI4770...
Medical Devices·572 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model ...
Surgical Devices·10,080 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: KIT,SUCTION CATH,14FR W/WATER, Model Number DYND41472
Medical Devices·24,192 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ARTHROSCOPY PACK, Model Number DYNJ44322G
Medical Devices·180 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY, Model Number DYNDL1134A; b...
Medical Devices·11,413 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER PACK, Model Number DYNJ67770A; b) EP ...
Cardiac Devices·3,740,814 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PROBE COVER PACK, Model Number DYNDA1219
Medical Devices·51,200 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) RADIAL ARTERIAL LINE KIT, Model Number ART1070A...
Surgical Devices·2,590 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905
Respiratory Devices·1,784 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VAD/PICC IV KIT, Model Number DYNDV2200; b)...
Medical Devices·8,974 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PACK ENDO AAA HYBRID CHRG, Model Number DYNJ60126B
Medical Devices·25 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL LINE START KIT , Model Number ART920; ...
Medical Devices·70,648 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA 701070412 HMO ...
Respiratory Devices·0 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK, Model Number DYNJ45158A
Medical Devices·36 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA ...
Respiratory Devices·0 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ81722; b) PAIN B...
Surgical Devices·28,568 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FEMORAL ARTERIAL LINE BUNDLE, Model Number ART1...
Surgical Devices·39,391 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST PACK, Model Number DYNDH1306; b) BRS...
Medical Devices·4,398 affected·May 18, 2023