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CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002
Medical Devices·1,483 affected·Mar 21, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000
Medical Devices·69 affected·Mar 21, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002
Medical Devices·217 affected·Mar 21, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012
Medical Devices·1 affected·Mar 21, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200
Medical Devices·383 affected·Mar 21, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002
Medical Devices·815 affected·Mar 21, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002
Medical Devices·15 affected·Mar 21, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012
Medical Devices·27 affected·Mar 21, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002
Medical Devices·5 affected·Mar 21, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000
Medical Devices·3,905 affected·Mar 21, 2025
CriticalFDA
Avanos Medical, Inc.
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description...
Surgical Devices·0 affected·Mar 19, 2025
CriticalFDA
Avanos Medical, Inc.
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Balla...
Surgical Devices·1,980 affected·Mar 19, 2025
CriticalFDA
Avanos Medical, Inc.
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Bal...
Surgical Devices·9,960 affected·Mar 19, 2025
CriticalFDA
Har Maspeth Corp.
Jinga Glass Noodles with vegetables 8 oz. and 12 oz.
Produce·2,627 affected·Mar 14, 2025
CriticalFDA
Dr. Reddy's Laboratories, Inc.
Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, H...
Injectable Drugs·4,010 affected·Mar 13, 2025
CriticalFDA
Thoratec Llc
HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Le...
Cardiac Devices·1,661 affected·Mar 13, 2025
CriticalFDA
Draeger, Inc.
Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Descripti...
Respiratory Devices·65,150 affected·Mar 12, 2025
CriticalFDA
Conavi Medical Inc.
Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Comm...
Surgical Devices·685 affected·Mar 12, 2025
CriticalFDA
Draeger, Inc.
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Version: Not app...
Medical Devices·3,140 affected·Mar 12, 2025
CriticalFDA
C.h. Guenther & Son Llc
365 Whole Foods Market Small Bites Macaroni & Cheese. Net Wt 8.5 oz (240g) Keep Frozen. UPC 99482499709. Distributed by: Whole Foods...
Dairy·1,818 affected·Mar 11, 2025
CriticalFDA
New Age International, Inc.
Daily Veggies Enoki Mushroom; Product of Korea; Net WT. 200 g (7.05 oz); KEEP REFRIGERATED; Cook through before
Food·2,720 affected·Mar 11, 2025
CriticalFDA
New York Wholesale Group
Zaarah Herbals brand Bhringraj Powder; packaged in 100g clear jars with gold lids; UPC: 6 35028 99973 1
Food·46 affected·Mar 10, 2025
CriticalFDA
New York Wholesale Group
Zaarah Herbals brand Gurmar Powder; packaged in 100g clear jars with gold lids; UPC: 6 35028 99969 4
Food·46 affected·Mar 10, 2025
CriticalFDA
New York Wholesale Group
Zaarah Herbals brand Vasaka Powder; packaged in 100g clear jars with gold lids; UPC: 6 35028 99967 0
Food·46 affected·Mar 10, 2025
CriticalFDA
New York Wholesale Group
Zaarah Herbals brand Rasayan Churan; packaged in 100g clear jars with gold lids; UPC:6 35028 99966 3
Food·46 affected·Mar 10, 2025
CriticalFDA
Ge Medical Systems, Llc
Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VG...
Diagnostic Devices·12,808 affected·Mar 6, 2025
CriticalFDA
Liaoning Cheng Da (usa) Inc
Wangzhine branded Hot Pot Sauce; Net Weight: 160 Grams, 5.64OZ; 36 units/case; UPC# 6907592001375
Food·3,650 affected·Mar 4, 2025
CriticalFDA
Liaoning Cheng Da (usa) Inc
Wangzhine branded Hot Pot Sauce (SPICY); Net Weight: 160 Grams, 5.64OZ; 36 units/case; UPC# 6907592001382
Food·3,420 affected·Mar 4, 2025
CriticalFDA
Zoll Circulation, Inc.
Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 87...
Medical Devices·91 affected·Mar 4, 2025
CriticalFDA
Little Leaf Farms Llc
Little Leaf Farms brand Southwest Salad Kit; 7.5 oz, clear plastic clamshell; UPC: 857394006220
Produce·576 affected·Feb 28, 2025
CriticalFDA
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Interoperable Technology
Diabetes Devices·63 affected·Feb 27, 2025
CriticalFDA
Covidien
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Medical Devices·780 affected·Feb 26, 2025
CriticalFDA
Lyons Magnus Llc
Ready Care Strawberry Shake No Sugar Added (4 oz), UPC 10045796017372; Imperial Strawberry Shake No Sugar Added (4 oz), UPC 00074865926843
Produce·763,250 affected·Feb 21, 2025
CriticalFDA
Lyons Magnus Llc
Ready Care Strawberry Shake (4 oz), UPC 10045796017358; Imperial Strawberry Shake (4 oz), UPC 00074865927017
Produce·763,250 affected·Feb 21, 2025
CriticalFDA
Lyons Magnus Llc
Ready Care Strawberry Shake Plus (4 oz), UPC 10045796017495
Produce·763,250 affected·Feb 21, 2025
CriticalFDA
Lyons Magnus Llc
Ready Care Chocolate Shake No Sugar Added (4 oz), UPC 10045796036335; Imperial Chocolate Shake No Sugar Added (4 oz), UPC 10734730244720
Snacks & Candy·763,250 affected·Feb 21, 2025
CriticalFDA
Lyons Magnus Llc
Ready Care Vanilla Shake No Sugar Added (4 oz), UPC 10045796017365; Imperial Vanilla Shake No Sugar Added (4 oz), UPC 00074865927031
Food·763,250 affected·Feb 21, 2025
CriticalFDA
Lyons Magnus Llc
Ready Care Vanilla Shake (4 oz), UPC 10045796017334; Imperial Vanilla Shake (4 oz), UPC 00074865926836
Food·763,250 affected·Feb 21, 2025
CriticalFDA
Lyons Magnus Llc
Ready Care Chocolate Shake (4 oz), UPC 10045796017341; Imperial Chocolate Shake (4 oz), UPC 00074865926997
Snacks & Candy·763,250 affected·Feb 21, 2025
CriticalFDA
Lyons Magnus Llc
Ready Care Chocolate Shake Plus (4 oz), UPC 10045796017471
Snacks & Candy·763,250 affected·Feb 21, 2025
CriticalFDA
Lyons Magnus Llc
Ready Care Strawberry Banana Shake No Sugar Added (4 oz), UPC 10045796018447; Imperial Strawberry Banana Shake No Sugar Added (4 oz), UP...
Produce·763,250 affected·Feb 21, 2025
CriticalFDA
Lyons Magnus Llc
Ready Care Vanilla Shake Plus (4 oz), UPC 10045796017549
Food·763,250 affected·Feb 21, 2025
CriticalFDA
Medline Industries, Lp - Northfield
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
Medical Devices·468 affected·Feb 21, 2025
CriticalFDA
Central Admixture Pharmacy Services, Inc.
PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 S...
Drugs·1,546 affected·Feb 20, 2025
CriticalFDA
One Source Nutrition, Inc,
Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.
Oral Drugs·300 affected·Feb 20, 2025
CriticalFDA
Akt Trading Inc.
Choshiya branded "RAKKYO ZUKE PREPARED VEGETABLES" UPC# JANCODE 4983673526021
Produce·800 affected·Feb 18, 2025
CriticalFDA
Akt Trading Inc.
Choshiya branded "SHIBA ZUKE PREPARED MIX VEGETABLES" UPC# JANCODE 4582207535128
Produce·1,000 affected·Feb 18, 2025
CriticalFDA
Akt Trading Inc.
Choshiya branded "SOFT TSUBOZUKE PREPARED MIX VEGETABLES" UPC# JANCODE 4582207535159
Produce·800 affected·Feb 18, 2025