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
www.fda.gov →Official Site

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68,659 recalls
CriticalFDA
Avid Medical, Inc.
DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.
Medical Devices·560 affected·Apr 9, 2021
CriticalFDA
Innova Medical Group, Inc.
COVID-19 Self-Test Kit *** INNOVA *** 3T
Diagnostic Devices·402 affected·Apr 9, 2021
CriticalFDA
Medical Action Industries, Inc. 306
Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B
Medical Devices·10 affected·Apr 9, 2021
CriticalFDA
Medical Action Industries, Inc. 306
Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420
Medical Devices·30 affected·Apr 9, 2021
CriticalFDA
Innova Medical Group, Inc.
For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309
Diagnostic Devices·1,945 affected·Apr 9, 2021
CriticalFDA
Avid Medical, Inc.
ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04
Medical Devices·130 affected·Apr 9, 2021
CriticalFDA
Medical Action Industries, Inc. 306
Kit: Blood Culture. MAI Kit Part Number: 80315D
Medical Devices·205 affected·Apr 9, 2021
High RiskFDA
Natrol, Llc
Natrol Melatonin 3 mg, Tab 60 White bottle with purple flip-top cap. Fall asleep faster, Stay asleep longer, 100$ Drug Free 1 Tablet 20...
Food·12,740 affected·Apr 8, 2021
High RiskFDA
J F C International Inc
J-Basket Premium Korean Seaweed Snack - Wasabi flavor on outer wrap for 3 inner packages Inner packages labeled J-Basket Premium Seaweed ...
Snacks & Candy·451 affected·Apr 8, 2021
CriticalFDA
Nsny Distributor Inc
Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Angeles, CA 90010, UPC 0 40232 18144 3
Oral Drugs·399 affected·Apr 8, 2021
CriticalFDA
Nsny Distributor Inc
Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co, Santa Fe Springs, CA, Made in USA , UPC 0 40232 32...
Oral Drugs·2,600 affected·Apr 8, 2021
High RiskFDA
Spes Medica
SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached...
Surgical Devices·34 affected·Apr 8, 2021
High RiskFDA
Meridian Bioscience Inc
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative t...
Medical Devices·376 affected·Apr 8, 2021
High RiskFDA
Spes Medica
Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuo...
Surgical Devices·20 affected·Apr 8, 2021
High RiskFDA
Spes Medica
Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.
Medical Devices·3 affected·Apr 8, 2021
High RiskFDA
Windstone Medical Packaging, Inc.
Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover Probe 6X48 NS...
Surgical Devices·114 affected·Apr 8, 2021
RecallFDA
Jansala & Foods Llc
Thai Home brand Panang Curry Paste packaged in glass jars. Net weight 6.5 oz (180g). Refrigerate after opening. UPC 0861608000485 ...
Dairy·99 affected·Apr 7, 2021
RecallFDA
Jansala & Foods Llc
Thai Home brand Satay Peanut Sauce packaged in glass jars. Net weight 6.5 oz (180g). Refrigerate after opening. UPC 8616080004078 ...
Dairy·59 affected·Apr 7, 2021
High RiskFDA
Snowville Creamery, Llc
Snowville Creamery Whipping Cream 64oz Paperboard Carton Sold as individual Units
Dairy·297 affected·Apr 7, 2021
RecallFDA
Jansala & Foods Llc
Thai Home brand Yellow Curry Paste packaged in glass jars. Net weight 6.5 oz (180g). Refrigerate after opening. UPC 8616080004030 ...
Dairy·165 affected·Apr 7, 2021
RecallFDA
Jansala & Foods Llc
Thai Home brand Mussaman Curry Paste packaged in glass jars. Net weight 6.5 oz (180g). Refrigerate after opening. UPC 8616080004047 ...
Dairy·105 affected·Apr 7, 2021
RecallFDA
Jansala & Foods Llc
Thai Home brand Red Curry Paste packaged in glass jars. Net weight 6.5 oz (180g). Refrigerate after opening. UPC 8616080004016 Ma...
Dairy·239 affected·Apr 7, 2021
RecallFDA
Jansala & Foods Llc
Thai Home brand Green Curry Paste packaged in glass jars. Net weight 6.5 oz (180g). Refrigerate after opening. UPC 8616080004023. ...
Dairy·169 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741045094 - Product Usage: is desig...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200592 - Product Usage: is designed fo...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)108...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, CE 2797, UD...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035279 - Product Usage: is designed for...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200615 - Product Usage: is designed fo...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 9617408D, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Maximal Barrier Kit, 4F, Single-Lumen, TLS, ...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 9617405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 69655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)1...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Roche Diagnostics Operations, Inc.
Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Diagnostic Devices·10 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035262 - Product Usage: is d...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Raysearch Laboratories Ab
RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some servic...
Medical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 9617407, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)108...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 9655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Twin City Foods, Inc.
Signature Select Golden Corn Sweet, frozen, packed in poly film bags. 12/16 oz. packages per case. UPC 2113009152. Signature Select Gold...
Frozen Food·90 affected·Apr 6, 2021
High RiskFDA
Hyobin Llc
PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
Oral Drugs·500 affected·Apr 6, 2021
High RiskFDA
Hyobin Llc
Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Par...
Oral Drugs·300 affected·Apr 6, 2021
High RiskFDA
Hyobin Llc
PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
Oral Drugs·500 affected·Apr 6, 2021
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Medical Implants·16,311 affected·Apr 6, 2021
High RiskFDA
Philips Respironics, Inc.
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177
Respiratory Devices·1 affected·Apr 6, 2021
High RiskFDA
Philips Respironics, Inc.
BiPAP A30, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111143
Respiratory Devices·2 affected·Apr 6, 2021
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also...
Cardiac Devices·16,311 affected·Apr 6, 2021
High RiskFDA
Philips Respironics, Inc.
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: 1111177
Respiratory Devices·4 affected·Apr 6, 2021
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also prov...
Medical Implants·575,815 affected·Apr 6, 2021
High RiskFDA
Philips Respironics, Inc.
BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111169
Respiratory Devices·4 affected·Apr 6, 2021