Source

FDA Recalls

The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.

68,659Total Recalls
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68,659 recalls
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-...
Medical Devices·143 affected·Sep 11, 2020
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or ex...
Medical Devices·1 affected·Sep 11, 2020
High RiskFDA
Bien-air Surgery Sa
Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive h...
Medical Devices·1,120 affected·Sep 11, 2020
High RiskFDA
Tandem Diabetes Care Inc
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Diabetes Devices·5,206 affected·Sep 10, 2020
High RiskFDA
Gilster-mary Lee Corp.
Microwave popcorn packaged in the following ways: 1) Full Circle Organic Microwave Popcorn Salted, 3-2.9 oz (82 g) bags, Net Wt. 8.7 o...
Snacks & Candy·1,890 affected·Sep 9, 2020
High RiskFDA
Shatto Milk Co
Shatto Milk Company, Brownie, Chocolate Brownie and Vanilla Ice Cream Sammich, Net Wt. 5 oz, Shatto Milk Company, Osborn, MO
Dairy·308 affected·Sep 9, 2020
High RiskFDA
Gilster-mary Lee Corp.
Light microwave popcorn packaged in the following ways: 1) Full Circle Organic Microwave Popcorn Light Butter, 3-2.9 oz (82 g) bags, N...
Dairy·972 affected·Sep 9, 2020
High RiskFDA
Gilster-mary Lee Corp.
Lightly salted microwave popcorn packaged in the following ways: 1) Cadia Organic Lightly Salted Popcorn, Net Wt. 9.9 oz (281 g) 3-3.3...
Dairy·320 affected·Sep 9, 2020
High RiskFDA
Shatto Milk Co
Shatto Milk Company, Choc + Chip, Chocolate Chip Cookie and Vanilla Ice Cream Sammich, Net Wt. 4.5 oz, Shatto Milk Company, Osborn, MO
Dairy·333 affected·Sep 9, 2020
High RiskFDA
Lidl Us Trading
Lidl Organic Butter Microwave Popcorn, 3 x 3.3oz, 10 boxes per case and 3 popcorn bags per box .
Dairy·3,782 affected·Sep 9, 2020
High RiskFDA
Gilster-mary Lee Corp.
Cadia Organic Unsalted Microwave Popcorn, Net Wt. 8.4 oz (238 g) 3-2.8 oz (79 g) bags, KeHDistributors LLC, Naperville, IL, UPC 15369-01289
Snacks & Candy·34 affected·Sep 9, 2020
RecallFDA
P & L Developments, Llc
Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton, Distributed By: Rite Aid, 30 Hunter Lane, Camp H...
Drugs·4,752 affected·Sep 9, 2020
CriticalFDA
Medek Llc
M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,785 mL, Made in Mexico by: Grupo Plast-Y-Kosas S.A. de C.V. P...
Topical Drugs·256 affected·Sep 9, 2020
RecallFDA
Pai Holdings, Llc. Dba Pharmaceutical Associates Inc
Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc. Greenville, SC 29605 N...
Oral Drugs·13,480 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological application...
Medical Devices·6 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
Medical Devices·0 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996
Medical Devices·0 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626
Medical Devices·0 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Ethicon, Inc.
VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approxima...
Medical Devices·1,032 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Encore Medical, Lp
EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous ...
Medical Devices·12 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applica...
Medical Devices·281 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
W L Gore & Associates, Inc.
GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Medical Implants·19,013 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Ponder Foods
Pretty Thai brand Sweet Chili Sauce Net Wt 11.2 oz (317g) UPC 860043001224 packaged in a clear PET plastic bottle with a white label.
Food·2,130 affected·Sep 8, 2020
High RiskFDA
Aesculap Implant Systems Llc
AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery.
Medical Devices·24 affected·Sep 8, 2020
High RiskFDA
Esaote S.p.a
AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180PS19-XE1057, AC/DC Adapter associated with the following ...
Diagnostic Devices·989 affected·Sep 8, 2020
High RiskFDA
Ge Healthcare, Llc
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolutio...
Medical Devices·30 affected·Sep 8, 2020