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All Product Recalls

49,195 recalls from FDA (high severity)

Source:AllCPSCFDAUSDASeverity:AllCriticalHighMedium
High RiskFDA
Aomori Olympus Co., Ltd.
NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used with ultrasound endoscopes for ultrasound guided ...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
K-204 GUIDE SHEATH KIT 2.6MM, model no. K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respirato...
Respiratory Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the b...
Respiratory Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
K-202 GUIDE SHEATH Kit 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respirato...
Respiratory Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
B7-2Q BALLOON CATHETER 13MM DIA 3.2, model no. B7-2Q -Product Usage: Used with endoscopes for injection of contrast medium or other medic...
Surgical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no. NM-400L-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for th...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
KD-650L ELECTROSURGICAL SNARE, model no. KD-650L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high...
Surgical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
PBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
Medical Implants·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
NEEDLEMASTER 5MMx 25G LOWER, model no. NM-610U-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal in...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2MM CH 23G 3MM, model no. NM-401L-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX LOWER 23G 6MM 5/BX, model no. NM-400U-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for th...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage: Used with endoscopes to perform endoscopic injection for th...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G, model no. NA-201SX-4022-A - Product Usage: Used with ultrasound endoscopes for ultrasound g...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Precision Dose Inc.
Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61, b) 15 mL x 100 Un...
Oral Drugs·1,107,510 affected·Jan 1, 2021
High RiskFDA
Ocean Providence Minneapolis Llc
Frozen Ground Tuna, Wild Caught, Production Date: 06/01/2020. Product of Vietnam, Net Wt: 11 lbs. x 2: 22 lbs. Imported by Khee Trading...
Seafood·790 affected·Dec 30, 2020
High RiskFDA
Allergan, Plc.
Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: Allergan, an AbbVie company Madison, ...
Ophthalmic Drugs·100,634 affected·Dec 30, 2020
High RiskFDA
Auromedics Pharma Llc
Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, Distributed by: AuroMedics Pha...
Injectable Drugs·3,094 affected·Dec 30, 2020
High RiskFDA
Baxter Healthcare Corporation
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for single use in a hem...
Medical Devices·211,155 affected·Dec 30, 2020
High RiskFDA
Baxter Healthcare Corporation
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 106289 - Product Usage: intended for single use in a hem...
Medical Devices·1,460 affected·Dec 30, 2020
High RiskFDA
Baxter Healthcare Corporation
Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the...
Medical Devices·7,437,480 affected·Dec 30, 2020
High RiskFDA
Baxter Healthcare Corporation
Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - Product Usage: intended for single u...
Medical Devices·57,825 affected·Dec 30, 2020
High RiskFDA
Baxter Healthcare Corporation
Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114435 - Product Usage: intended f...
Medical Devices·25,785 affected·Dec 30, 2020
High RiskFDA
Baxter Healthcare Corporation
Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment u...
Medical Devices·385 affected·Dec 30, 2020
High RiskFDA
Avalanche Distributing, Llc
Valanga Gourmet brand Snickerdoodle Cookie with cinnamon sugar on the outside. Each cookie is wrapped and sold individually. Expected she...
Dairy·1,700 affected·Dec 29, 2020
High RiskFDA
Port City Bakery, Inc
AK 10 5/8" Par Baked Stuffed Crust, frozen Pizza Crust, Item 1115660, Case Count / Unit Weight, 283 Count / 21.5 oz. Keep Frozen at 0 ...
Frozen Food·562,812 affected·Dec 29, 2020
High RiskFDA
Port City Bakery, Inc
Dough Shop Par Baked Crust, frozen pizza crusts packaged in the following sizes: 1. 16" Item # DS22316, Count / Unit Weight 14 Cou...
Frozen Food·562,812 affected·Dec 29, 2020
High RiskFDA
Port City Bakery, Inc
Ultimo! ParBaked Raised Edge Pizza Crust packaged in the following sizes: 1. 16" Reorder # 545145, 12 - 18 oz Crusts. Net Wt 13.5 ...
Food·562,812 affected·Dec 29, 2020
High RiskFDA
Sunstar Americas, Inc.
Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl o...
Oral Drugs·1,021,914 affected·Dec 28, 2020
High RiskFDA
Akorn, Inc.
Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-2...
Oral Drugs·22,248 affected·Dec 28, 2020
High RiskFDA
Mar-med Co
Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be use...
Medical Devices·52,000 affected·Dec 28, 2020
High RiskFDA
Baxter Healthcare Corporation
FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascula...
Medical Implants·109 affected·Dec 28, 2020
High RiskFDA
New Standard Device Inc
Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5...
Medical Devices·410 affected·Dec 28, 2020
High RiskFDA
Philips Ultrasound Inc
Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi ...
Diagnostic Devices·12,080 affected·Dec 24, 2020
High RiskFDA
Shane Erickson Inc
IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 1.7 fl. oz. (50 ml) bottles, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55...
Drugs·36,505 affected·Dec 23, 2020
High RiskFDA
Shane Erickson Inc
IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Par...
Drugs·42,157 affected·Dec 23, 2020
High RiskFDA
Genus Lifesciences Inc.
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05 Case NDC: 64950-354...
Oral Drugs·1,171,550 affected·Dec 23, 2020
High RiskFDA
Shane Erickson Inc
IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 10.1 fl. oz. (300 ml), Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Pa...
Drugs·29,376 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903)
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
Diagnostic Devices·0 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Deluxe At Home Pro Series Insemination Kit (SKU 644042787958)
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Biomet, Inc.
A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, oste...
Medical Devices·174 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Premium At Home Pro Series Insemination Kit (SKU 644042787927)
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931,...
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)
Medical Devices·0 affected·Dec 23, 2020