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High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
Medical Devices·44 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2) LOCAL BASIC, REF DYNJ34418L; 3) LOCAL BAS...
Medical Devices·182 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3) PLASTIC PACK, R...
Medical Devices·1,271 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672
Medical Devices·30 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W; 3) C-SECTION, RE...
Medical Devices·58,765 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B
Medical Devices·36 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF, REF CDS840233I; 3) GENERAL AAA #11-RF, REF CDS8...
Cardiac Devices·30,092 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK...
Medical Devices·12,847 affected·Oct 9, 2024
High RiskFDA
The Metrix Company
SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain a fluid for intr...
Medical Devices·2,921 affected·Oct 9, 2024
High RiskFDA
The Metrix Company
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plastic intended to contain a fluid for intr...
Medical Devices·2,229 affected·Oct 9, 2024
High RiskFDA
The Metrix Company
Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain a fluid for intra...
Medical Devices·864 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331D
Medical Devices·486 affected·Oct 9, 2024
High RiskFDA
The Metrix Company
VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to contain a fluid for in...
Medical Devices·288 affected·Oct 9, 2024
High RiskFDA
The Metrix Company
Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended to contain a fluid for intra...
Medical Devices·768 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I; 2) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0...
Cardiac Devices·14,388 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN ...
Medical Devices·13,057 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2) D-CIRCUMCISION PACK, REF DYNJ64432; 3) PACK,CIRCUMCI...
Medical Devices·828 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J
Medical Devices·88 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS985431K; 3) TOT/...
Medical Devices·478 affected·Oct 9, 2024
High RiskFDA
The Metrix Company
CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastic intended to contain a fluid for in...
Medical Devices·1,920 affected·Oct 9, 2024
High RiskFDA
The Metrix Company
SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended to contain a fluid for intra...
Medical Devices·1,013 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF...
Medical Devices·3,452 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS PACK-LF, REF DYNJ0101291F; 3) MAJOR VASCULAR ...
Medical Devices·0 affected·Oct 9, 2024
High RiskFDA
The Metrix Company
Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made of plastic intended to contain a fluid for intra...
Medical Devices·1,056 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Refer to RES or lead review memo for complete list of affected reference/catalog numbers
Medical Devices·102,561 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) ORAL MAXILOFACIAL P...
Medical Devices·944 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN CLOSURE PACK GREEN, REF DYNJ84667
Medical Devices·66 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M; 3) MAJOR VAGINAL PACK-...
Medical Devices·1,952 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2) PELVISCOPY PACK-LF, REF DYNJ0843760I; 3) P...
Medical Devices·336 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; ...
Medical Implants·24,754 affected·Oct 9, 2024
High RiskFDA
The Metrix Company
CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to contain a fluid for in...
Medical Devices·1,440 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATARACT PACK, REF DYN...
Medical Devices·1,921 affected·Oct 9, 2024
High RiskFDA
Del Monte Fresh Produce N.a., Inc.
Del Monte Fresh Produce, Pineapple and Apple Salad 4/6.5oz plastic container, four containers per case. Refrigerated. Lot Code 02277101, ...
Produce·55 affected·Oct 8, 2024
High RiskFDA
Neogen Corporation
LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed By: Bob Barker Company, Inc., 7925 Pu...
Drugs·5,328 affected·Oct 8, 2024
High RiskFDA
C & A Naturistics
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
Oral Drugs·0 affected·Oct 8, 2024
High RiskFDA
Neogen Corporation
LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL mL) per jug, Distributed By: Bob Barker Company, Inc., 7925...
Drugs·8,328 affected·Oct 8, 2024
High RiskFDA
Cook Incorporated
Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
Medical Devices·5,953 affected·Oct 8, 2024
High RiskFDA
Apple Wedge Llc
100% CIDER Pasteurized APPLE WEDGE CIDER 1 Gal. (3.78L) HENDERSONVILLE, NC 28792 Keep Refrigerated 0.1% Potassium Sorbate as Preservative...
Food·218 affected·Oct 7, 2024
High RiskFDA
Apple Wedge Llc
No Preservatives 100% CIDER Pasteurized APPLE WEDGE CIDER 1/2 Gal. (1.89L) HENDERSONVILLE, NC 28792 Keep Refrigerated Produce of USA UPC ...
Produce·48 affected·Oct 7, 2024
High RiskFDA
Apple Wedge Llc
Cinnamon Pasteurized APPLE WEDGE CIDER 1/2 Gal. (1.89L) HENDERSONVILLE, NC 28792 Keep Refrigerated Produce of USA Ingredients: Apples, Na...
Produce·96 affected·Oct 7, 2024
High RiskFDA
Nestle Product Technology Center - Nestle Health Science
Douglas Labs Stress-B-Plus Dietary Supplement, Tablets, 90 tablets per bottle. UPC # 10539 97452, Lot Numbers ,50335944 and 50344396. Ex...
Supplements·3,269 affected·Oct 7, 2024
High RiskFDA
Drg International, Inc.
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Diabetes Devices·10 affected·Oct 7, 2024
High RiskFDA
Hobbs Medical, Inc.
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723
Medical Devices·10 affected·Oct 4, 2024
High RiskFDA
Caire, Inc.
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
Respiratory Devices·26 affected·Oct 4, 2024
High RiskFDA
Hobbs Medical, Inc.
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722
Medical Devices·198 affected·Oct 4, 2024
High RiskFDA
Hobbs Medical, Inc.
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721
Medical Devices·15 affected·Oct 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
Surgical Devices·36 affected·Oct 4, 2024
High RiskFDA
Hobbs Medical, Inc.
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718
Medical Devices·12 affected·Oct 4, 2024