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High RiskFDA
Medline Industries, Lp - Northfield
Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2) ARTHROSCOPY PACK-LF, Pack Number DYNJ0390808F; ...
Medical Devices·186 affected·Feb 11, 2025
High RiskFDA
Nephron Sterile Compounding Center Llc
Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, N...
Injectable Drugs·4,190 affected·Feb 10, 2025
High RiskFDA
Immuno-mycologics, Inc
Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates ...
Medical Devices·30 affected·Feb 10, 2025
High RiskFDA
Brainlab Ag
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Medical Devices·0 affected·Feb 10, 2025
High RiskFDA
Heb
" Spinach Artichoke Dip (Sold Hot) 1 lb " Spinach Artichoke Dip (Sold Cold) 1 lb " Spinach Artichoke Dip (Sold in Bulk for Customer Self ...
Produce·45 affected·Feb 9, 2025
High RiskFDA
Jesse's Bakery, Inc.
Pan de Coco (Coconut Rolls), net wt. 9oz (255g), product is packaged as 6 rolls on a yellow styrofoam plate, then placed in a flexible po...
Dairy·141 affected·Feb 7, 2025
High RiskFDA
Aspen Biopharma Labs Pvt., Ltd.
Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
Drugs·5 affected·Feb 7, 2025
High RiskFDA
Aspen Biopharma Labs Pvt., Ltd.
Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied each indivi...
Drugs·120 affected·Feb 7, 2025
High RiskFDA
Aspen Biopharma Labs Pvt., Ltd.
Alprostadil Container Description: Amber color bottle
Drugs·3 affected·Feb 7, 2025
High RiskFDA
Aspen Biopharma Labs Pvt., Ltd.
Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover ...
Drugs·400 affected·Feb 7, 2025
High RiskFDA
Aspen Biopharma Labs Pvt., Ltd.
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
Drugs·150 affected·Feb 7, 2025
High RiskFDA
Aspen Biopharma Labs Pvt., Ltd.
Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual ...
Drugs·4 affected·Feb 7, 2025
High RiskFDA
Cardiofocus, Inc.
CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of a...
Cardiac Devices·833 affected·Feb 7, 2025
High RiskFDA
Cordis Us Corp
Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introd...
Surgical Devices·12 affected·Feb 7, 2025
High RiskFDA
Padagis Us Llc
Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 4580...
Topical Drugs·4,944 affected·Feb 6, 2025
High RiskFDA
Sun Pharmaceutical Industries Inc
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ ...
Oral Drugs·9,840 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
Medical Devices·147 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
LABOR & DELIVERY PACK, Model Nos LLLD19H
Medical Devices·725 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
Medical Devices·1,420 affected·Feb 6, 2025
High RiskFDA
Integra Lifesciences Corp.
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catal...
Medical Devices·623 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
Medical Devices·534 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
C-SECTION PACK, Model Nos LLCS44F LLCS44F-01
Medical Devices·252 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
DIAGNOSTIC NEURO IR TRAY , Model No WENE21
Diagnostic Devices·170 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
DELIVERY PACK , Model No SGDV22D-01 SGDV22E
Medical Devices·36 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
Cardiac Devices·90 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
Medical Devices·388 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
Medical Devices·690 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
Medical Devices·237 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
CYSTO , Model No SACY80R
Medical Devices·144 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
Medical Devices·1,200 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
Medical Devices·1,836 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
Medical Devices·48 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
CYSTO PACK , Model N. HKCY31A
Medical Devices·36 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
BORN ON ARRIVAL KIT , Model No LLBN11B
Medical Devices·54 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
Medical Devices·41 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
Medical Devices·956 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
Medical Devices·1,106 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
AV FISTULA , Model No UTAV77T
Medical Devices·90 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
THORACIC PACK , Model No UTTC82Y UTTC82AA-01
Medical Devices·40 affected·Feb 6, 2025
High RiskFDA
Feel Good Foods Inc
Feel Good Foods; Three Cheese Mac & Cheese Bites; NET WT 8oz (224g); packaged in yellow carton; 9 units per case; Frozen; UPC: 89903900280-8
Dairy·4,246 affected·Feb 5, 2025
High RiskFDA
Stiebs, Llc
Organic Acai Bowl with berries, bananas, granola and dried coconut; Net Wt. 10 oz (284g); Frozen storage; Packaged in paper bowl with he...
Bakery & Grains·25,484 affected·Feb 5, 2025
High RiskFDA
Medical Information Technology, Inc.
MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for ...
Medical Devices·148 affected·Feb 5, 2025
High RiskFDA
Chicken Of The Sea; Thai Union
Genova branded Solid white Tuna; In Olive Oil; Wild Caught; NET WT. 5 OZ (142g) RD WT. 4 OZ (113g); Distributed by Tri-Union Seafoods, LL...
Seafood·14,147 affected·Feb 4, 2025
High RiskFDA
Pacific Coast Fresh Co
Item #96527 and item #32902, King Harvest Spinach Hummus, net wt. 10oz., UPC 025726 31108 7, perishable and refrigerated, packed in seale...
Produce·3,176 affected·Feb 4, 2025
High RiskFDA
Pacific Coast Fresh Co
Item #96514 and item #32903, King Harvest Black Olive Hummus, net wt. 10oz., UPC 025726 31121 6, perishable and refrigerated, packed in s...
Food·4,019 affected·Feb 4, 2025
High RiskFDA
Pacific Coast Fresh Co
Item #96524, King Harvest Toasted Onion Hummus, net wt. 10oz., UPC 025726 31129 2, perishable and refrigerated, packed in sealed plastic ...
Produce·2,179 affected·Feb 4, 2025
High RiskFDA
Pacific Coast Fresh Co
Item #96507 and item# 32901, King Harvest Balsamic Hummus, net wt. 10oz., UPC 025726 310097, perishable and refrigerated, packed in seale...
Food·4,406 affected·Feb 4, 2025
High RiskFDA
Chicken Of The Sea; Thai Union
HEB branded Solid White Albacore Tuna in water; Wild Caught; NET WT. 5 OZ (142g) DR WT. 4 OZ (113g); Made with Pride and Care for H-E-B, ...
Seafood·14,147 affected·Feb 4, 2025