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
Zoll Circulation, Inc.
Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HE...
Surgical Devices·1,256 affected·Aug 6, 2021
High RiskFDA
Intuitive Surgical, Inc.
Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
Medical Devices·1,625 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Medical Devices·1,122 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)
Medical Devices·55 affected·Aug 6, 2021
High RiskFDA
Heartware, Inc.
Medtronic HVAD Pump Implant Kits
Medical Implants·11,851 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens...
Surgical Devices·1,733 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)
Medical Devices·334 affected·Aug 6, 2021
CriticalFDA
Smiths Medical Asd Inc.
NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
Medical Devices·519,250 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capab...
Surgical Devices·5,524 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only,...
Surgical Devices·4,812 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capabilities (3 lumen...
Surgical Devices·11 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEP...
Surgical Devices·33,066 affected·Aug 6, 2021
RecallFDA
Hikma Pharmaceuticals Usa Inc.
Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben ...
Injectable Drugs·1,152 affected·Aug 5, 2021
High RiskFDA
Dupont Nutrition Usa, Inc
Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Og...
Drugs·2,384,720 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device
Medical Devices·5,950 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Surgical Devices·1,140 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device
Medical Devices·960 affected·Aug 5, 2021
High RiskFDA
M.d.l. S.r.l.
Soft Tissue Biopsy Needles
Medical Devices·20,129 affected·Aug 5, 2021
High RiskFDA
M.d.l. S.r.l.
Mammary Nodules Localization
Medical Devices·320 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device
Medical Devices·1,440 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device
Medical Devices·1,710 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter
Medical Devices·80 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Surgical Devices·2,660 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device
Medical Devices·10,150 affected·Aug 5, 2021
CriticalFDA
Armstrong Medical Services Limited
AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia.
Medical Devices·214,032 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
Medical Devices·420 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
Medical Devices·350 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
Medical Devices·11,600 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
Medical Devices·40 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Surgical Devices·33,380 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Surgical Devices·18,060 affected·Aug 5, 2021
High RiskFDA
M.d.l. S.r.l.
General Manual surgical instrument
Surgical Devices·4,120 affected·Aug 5, 2021
CriticalFDA
Dsd Merchandisers, Inc.
Dark Chocolate Malt Balls in plastic container; 9 oz./ 255g UPC: 6 5143370179 0 Packed on the same equipment as products that contain ...
Dairy·252 affected·Aug 4, 2021
High RiskFDA
Olam Edible Nuts-blakely,ga
Raw Shelled Peanuts, Skins Removed, Split Nut Blanched Runner Peanuts, Net. Wt. 2000# Olam Edible Nuts - Blakely, GA
Food·15,718 affected·Aug 4, 2021
High RiskFDA
Molly And Me Pecans
MOLLY & ME PECANS all natural PRALINE PECANS, 4 oz., 7 oz., and 12 oz packages, INGREDIENTS: Pecans, Brown Sugar, Evaporated Milk, Margar...
Dairy·1,221 affected·Aug 4, 2021
CriticalFDA
Cardinal Health
Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in f...
Medical Devices·267,217,860 affected·Aug 4, 2021
CriticalFDA
Cardinal Health
Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in ...
Medical Devices·267,217,860 affected·Aug 4, 2021
High RiskFDA
Roche Molecular Systems, Inc.
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Medical Devices·211 affected·Aug 4, 2021
CriticalFDA
Cardinal Health
Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in...
Medical Devices·267,217,860 affected·Aug 4, 2021
High RiskFDA
Abbott Molecular, Inc.
Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ ...
Medical Devices·186 affected·Aug 4, 2021
High RiskFDA
Cocanu Llc
Moonwalk 70% dark chocolate bar. It is packaged in white shiny paper with blue print. Net Weight: 1.2 oz / 35gr. No UPC. The label is ...
Dairy·852 affected·Aug 3, 2021
High RiskFDA
The Harvard Drug Group
Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Sui...
Oral Drugs·2,239 affected·Aug 3, 2021
CriticalFDA
Teligent Pharma, Inc.
Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey 08310, NDC 52565...
Topical Drugs·32,544 affected·Aug 3, 2021
High RiskFDA
Olympus Corporation Of The Americas
Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420...
Medical Devices·711,157 affected·Aug 3, 2021
High RiskFDA
Fresenius Medical Care Holdings, Inc.
AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-...
Medical Devices·2 affected·Aug 3, 2021
High RiskFDA
Luminex Corporation
Verigene EP Amplification Reagent Kit Test
Diagnostic Devices·4,579 affected·Aug 3, 2021
CriticalFDA
Golden Natural Products
Golden Natural Product Inc. brand Dried Apricot Subkhon with Bone, Net Wt. 16 oz (1 lb) 454 g; and Golden Natural Product Inc. brand Drie...
Food·0 affected·Aug 2, 2021
CriticalFDA
Je Dois Lavoir Llc
365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL
Oral Drugs·783 affected·Aug 2, 2021