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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How to report to FDA →68,659 recalls
High RiskFDA
Philips North America Llc
IntelliVue Patient Monitor MX400. Model Number: 866060
Medical Devices28 affectedJan 15, 2025
High RiskFDA
Philips North America Llc
IntelliVue Patient Monitor MX450. Model Number: 866062
Medical Devices98 affectedJan 15, 2025
CriticalFDA
Olympus Corporation Of The Americas
Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2...
Respiratory Devices454 affectedJan 15, 2025
High RiskFDA
Philips North America Llc
IntelliVue Patient Monitor MX550. Model Number: 866066
Medical Devices74 affectedJan 15, 2025
High RiskFDA
Deroyal Industries Inc
DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement
Medical Devices224,770 affectedJan 15, 2025
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System
Medical Devices64 affectedJan 15, 2025
High RiskFDA
Philips North America Llc
IntelliVue Patient Monitor MX500. Model Number: 866064
Medical Devices45 affectedJan 15, 2025
CriticalFDA
Getinge Usa Sales Inc
Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For...
Medical Devices6 affectedJan 15, 2025
High RiskFDA
Target Corporation
Nestle Toll House Valentine's Chocolate Chip cookie dough, Makes 20 cookies. Net wt 14 oz. UPC 0 28000-34408 5. Distributed by Nestle...
Bakery & Grains2,904 affectedJan 14, 2025
CriticalFDA
Frito-lay, Inc. Headquarters
Pearl Milling Company Original Pancake & Waffle Mix 32 OZ (2LB) 907g 30000 65040 BBD SEP 13 25 P
Bakery & Grains10,000 affectedJan 14, 2025
High RiskFDA
Draeger Medical Systems, Inc.
Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, ped...
Medical Devices1,013 affectedJan 14, 2025
High RiskFDA
Monkey Spit
Monkey Spit "Atomic Mop" BBQ Sauce, 12 fl oz (355ml) glass bottle, 12 bottles/case; Refrigerate after opening; Manufactured by Smith Hous...
Food64 affectedJan 13, 2025
High RiskFDA
Monkey Spit
Monkey Spit "Monkey Mop" BBQ Sauce, 12 fl oz (355ml) glass bottle, 12 bottles/case; Refrigerate after opening; Manufactured by Smith Hous...
Food155 affectedJan 13, 2025
High RiskFDA
Monkey Spit
Monkey Spit "Swamp Mop" BBQ Sauce, 12 fl oz (355ml) glass bottle, 12 bottles/case; Refrigerate after opening; Monkey Spit, LLC, Tepusquet...
Food80 affectedJan 13, 2025
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses ...
Oral Drugs6,408 affectedJan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 3 M12 System Code: (1) 722063 (2) 722221
Medical Devices9 affectedJan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
Medical Devices479 affectedJan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
Medical Devices735 affectedJan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Allura CV20; Catalog numbers: 722031
Medical Devices111 affectedJan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
Medical Devices4,221 affectedJan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.
Medical Devices263 affectedJan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235
Medical Devices90 affectedJan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura CV20 System Code: 722031
Medical Devices119 affectedJan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236
Medical Devices251 affectedJan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028
Medical Devices1,528 affectedJan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
Medical Devices5,029 affectedJan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.
Medical Devices3 affectedJan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
AlluraXperFD20/10 System Code: (1) 722029
Medical Devices22 affectedJan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013
Medical Devices66 affectedJan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/15; Catalog numbers: 722058
Medical Devices302 affectedJan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 (3) 722233
Medical Devices1,346 affectedJan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).
Medical Devices282 affectedJan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035
Medical Devices1 affectedJan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
AlluraXperFD20/15 System Code: (1) 722058
Medical Devices69 affectedJan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 5 M12 System Code: (1) 722227 (2) 722231
Medical Devices6 affectedJan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027
Medical Devices146 affectedJan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
Medical Devices2 affectedJan 13, 2025
CriticalFDA
Seoul Trading, Inc.
Item IL1014A, PIGGY Lotte Crispy Crunch Ice Cream Cone, Strawberry flavor, Keep Frozen, (4/5/160ML), UPC 8801118255045. Product of Korea....
Dairy78 affectedJan 10, 2025
High RiskFDA
Teva Pharmaceuticals Usa, Inc
Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, ...
Injectable Drugs34,636 affectedJan 10, 2025
High RiskFDA
Integra Lifesciences Corp.
Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Produ...
Medical Devices12,166 affectedJan 10, 2025
CriticalFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the co...
Medical Devices23 affectedJan 10, 2025
CriticalFDA
Spectranetics Corporation
Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm...
Medical Implants2,939 affectedJan 10, 2025
High RiskFDA
Beckman Coulter Laboratory Systems (suzhou) Co., Ltd.
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
Medical Devices56 affectedJan 10, 2025
High RiskFDA
Global Commodities Inc
AAHU BARAH brand SOFT PLUM; NET WT. 0.5 LB; Import By: AAHU BARAH USA, INC.; Soft Plum Aloo Bukahara 1/2 LB; *May Contain Sulfites As pre...
Food0 affectedJan 9, 2025
High RiskFDA
Kung Shin Plastics Co. Ltd.
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Medical Devices30,000 affectedJan 9, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number DYNJAA254A; 2) ADULT MAIN DISP. INTUB PART A, M...
Medical Devices70 affectedJan 9, 2025
High RiskFDA
Kung Shin Plastics Co. Ltd.
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: ...
Medical Devices50,000 affectedJan 9, 2025
High RiskFDA
Johnson, S C And Son, Inc
babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL...
Drugs57,184 affectedJan 8, 2025