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
St Jude Medical Inc.
Merlin PCS programmer (Model # 3650), Software (Model # 3330)
Medical Devices·71,651 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-4...
Medical Devices·40,738 affected·Apr 16, 2018
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
Medical Implants·1 affected·Apr 16, 2018
High RiskFDA
Trimed Inc.
Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation ...
Surgical Devices·722 affected·Apr 16, 2018
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
Medical Implants·2 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-...
Medical Devices·81,338 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, ...
Medical Devices·131,093 affected·Apr 16, 2018
High RiskFDA
Spinal Elements
AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Dev...
Medical Implants·19 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 10...
Medical Devices·22,132 affected·Apr 16, 2018
High RiskFDA
Cook Inc.
Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0; UDI: 1082700252264...
Surgical Devices·40 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/1000431...
Medical Devices·68,117 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001,...
Medical Devices·37,485 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 10011620...
Medical Devices·139,351 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-3...
Medical Devices·71,651 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring...
Cardiac Devices·986 affected·Apr 16, 2018
RecallFDA
Driscoll's Strawberry Associates, Inc.
Driscoll's Blackberries; 6 oz. clamshell container; Keep refrigerated. Product of Mexico Driscoll's Inc. Watsonville, CA 95077
Produce·264 affected·Apr 15, 2018
CriticalFDA
Cal Maine Foods
Shelled Eggs, Extra Large 18pk sold under the brand names of Publix UPC 0 41415 00966 0 & Sunups UPC 0 28621 36398 4
Food·23,400 affected·Apr 14, 2018
CriticalFDA
Eataly Ny, Llc (duty Only)
eataly artichoke spread, net wt. 7oz 200g, UPC 612067
Food·53 affected·Apr 14, 2018
CriticalFDA
Rose Acre Farm
Shell Eggs packaged in quantities and styles of pack (plastic and pulp cartons, flats, and boxes)
Food·206,749,248 affected·Apr 13, 2018
CriticalFDA
Cheezwhse/com
Formagere de la Brie brand, l 'Explorateur, soft ripened cheese made from pasteurized milk, product comes in a 250g (8.8 oz), clear plast...
Dairy·22 affected·Apr 13, 2018
High RiskFDA
Kanan Enterprises, Inc.
Market District Roasted Salted Cashews Whole Fancy Net WT 26 oz (1LB 10 OZ) 737g. Ingredients: Cashews, Canola and/or Peanut Oil, Salt. ...
Food·228 affected·Apr 13, 2018
High RiskFDA
Lyne Laboratories, Inc.
Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA...
Topical Drugs·23,453 affected·Apr 13, 2018
High RiskFDA
Lyne Laboratories, Inc.
Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufac...
Topical Drugs·17,939 affected·Apr 13, 2018
RecallFDA
Septodont Inc.
OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed b...
Injectable Drugs·8,509 affected·Apr 13, 2018
High RiskFDA
Lyne Laboratories, Inc.
Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA...
Topical Drugs·12,572 affected·Apr 13, 2018
RecallFDA
Boiron Inc.
Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA
Topical Drugs·52,810 affected·Apr 13, 2018
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
Medical Devices·276 affected·Apr 13, 2018
High RiskFDA
Trimed Inc.
Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e)...
Medical Devices·706 affected·Apr 13, 2018
High RiskFDA
Trimed Inc.
Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
Medical Devices·323 affected·Apr 13, 2018
High RiskFDA
St Jude Medical, Cardiac Rhythm Management Division
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name o...
Cardiac Devices·2,906 affected·Apr 13, 2018
High RiskFDA
Cardiovascular Systems Inc
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Product Usage: Us...
Medical Implants·18 affected·Apr 13, 2018
CriticalFDA
Carefusion 303, Inc.
Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected ...
Medical Devices·607,618 affected·Apr 13, 2018
High RiskFDA
Trimed Inc.
Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
Medical Devices·532 affected·Apr 13, 2018
High RiskFDA
Coltene Whaledent Inc
Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tu...
Medical Devices·11 affected·Apr 13, 2018
High RiskFDA
Trimed Inc.
Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f)...
Medical Devices·1,194 affected·Apr 13, 2018
CriticalFDA
Ama Wholesale
Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc. Chino Hills, CA, 91709-2618, UPC Code: ...
Oral Drugs·0 affected·Apr 12, 2018
RecallFDA
Sugarfina, Llc
Sugarfina Platinum Bling Ring; Product SKU No. R-1790 UPC: 840278116139 Net W. 21g ().7 oz.) Sculpted from dark chocolate, these in...
Dairy·1,342 affected·Apr 11, 2018
CriticalFDA
Seabear Company
Cold Smoked Wild Coho Salmon Lox , Gerard & Dominique Seafoods brand, Reduced Oxygen Packaging, Net Wt. 3 oz (85g). UPC 7 52047 92635 4....
Seafood·2,080 affected·Apr 11, 2018
CriticalFDA
Seabear Company
Hot Smoked Keta Beergarden Salmon, Seabear brand, Reduced Oxygen Packaging, Net Wt. 4oz (113g). No UPC.
Seafood·381 affected·Apr 11, 2018
High RiskFDA
Riba Foods Inc
Four J Charred Tomato & Basil Sauce 24 oz packaged in a glass jar, 6 units per case
Produce·1,087 affected·Apr 11, 2018
High RiskFDA
Premier Pharmacy Labs Inc
NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Premier Pharmacy Labs. 8265 Commercial Way Weeki Wachee, FL 34...
Drugs·600 affected·Apr 11, 2018
High RiskFDA
Premier Pharmacy Labs Inc
Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-...
Injectable Drugs·4,555 affected·Apr 11, 2018
High RiskFDA
Premier Pharmacy Labs Inc
Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-...
Injectable Drugs·4,192 affected·Apr 11, 2018
High RiskFDA
Premier Pharmacy Labs Inc
Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-249-10
Drugs·3,570 affected·Apr 11, 2018
High RiskFDA
Stryker Neurovascular
FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
Surgical Devices·968 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
4Fr. Catheter Clamp with Fastener; Product Code: CC-00004
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
8Fr. Catheter Clamp with Fastener; Product Code: CC-00008
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Becton Dickinson & Company
The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, t...
Diagnostic Devices·0 affected·Apr 11, 2018