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
CriticalFDA
Philips Respironics, Inc.
BiPAP V30 Auto Ventilator, Part Number 1111178
Respiratory Devices·5,958 affected·Mar 26, 2024
High RiskFDA
Surgical Specialties
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
Medical Devices·2,459 affected·Mar 26, 2024
CriticalFDA
Philips Respironics, Inc.
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111...
Respiratory Devices·6 affected·Mar 26, 2024
High RiskFDA
Baxter Healthcare Corporation
Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP, BLUET...
Medical Devices·11,154 affected·Mar 26, 2024
CriticalFDA
Philips Respironics, Inc.
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1...
Respiratory Devices·3 affected·Mar 26, 2024
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 0880...
Oral Drugs·2,784 affected·Mar 25, 2024
RecallFDA
Novitium Pharma Llc
Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor,...
Oral Drugs·1,003 affected·Mar 25, 2024
CriticalFDA
Sonarmed Inc
AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
Medical Devices·145 affected·Mar 25, 2024
High RiskFDA
Ossur H / F
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
Medical Implants·0 affected·Mar 25, 2024
High RiskFDA
Ossur H / F
RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component
Medical Implants·1 affected·Mar 25, 2024
High RiskFDA
Ossur H / F
RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Medical Implants·107 affected·Mar 25, 2024
High RiskFDA
Ossur H / F
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Medical Implants·143 affected·Mar 25, 2024
High RiskFDA
The Coastal Companies Dba Hearn Kirkwood
Egg salad sandwich packaged in clamshell for individual sale. 7.22oz (205g) UPC 766375938415
Produce·551 affected·Mar 23, 2024
CriticalFDA
Aruba Aloe Balm N.v.
Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC 0 82252 03120 9 (...
Topical Drugs·9,625 affected·Mar 23, 2024
CriticalFDA
Aruba Aloe Balm N.v.
Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 1...
Topical Drugs·5,299 affected·Mar 23, 2024
RecallFDA
Pepsico Inc.
12 oz Aluminum cans of root beer packaged 12 cans per carton. 2/12pks per case
Food·2,801 affected·Mar 22, 2024
High RiskFDA
Integradose Compounding Services Llc
fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Min...
Injectable Drugs·187 affected·Mar 22, 2024
High RiskFDA
B. Braun Medical Inc
Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00
Injectable Drugs·7,800 affected·Mar 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500
Medical Devices·0 affected·Mar 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOW...
Cardiac Devices·26,096 affected·Mar 22, 2024
High RiskFDA
Ebi, Llc
48" Lead Wires, Replacement Part Number: 1067724-4
Medical Devices·594 affected·Mar 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929K
Medical Devices·0 affected·Mar 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDOSCOPY KIT, REF DY...
Surgical Devices·22,891 affected·Mar 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b) BRONCH KIT, REF DYKE1007B; c) ENT, REF DYN...
Medical Devices·6,998 affected·Mar 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG
Medical Devices·316,125 affected·Mar 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN KIT, REF DYKM1184; c) DENTAL CDS, REF CDS984...
Medical Devices·75,098 affected·Mar 22, 2024
High RiskFDA
Ebi, Llc
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary ...
Medical Devices·0 affected·Mar 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DYKC1289F
Medical Devices·160 affected·Mar 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926
Medical Devices·88,703 affected·Mar 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM2169
Medical Devices·1,700 affected·Mar 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A
Medical Devices·99 affected·Mar 22, 2024
High RiskFDA
Shearer's Foods, Llc
Great Value Twist & Shout Strawberry Creme Sandwich Cookies, Net WT 15.35 oz. box containing film wrapped trays of stacked cookies. 12 bo...
Bakery & Grains·112 affected·Mar 21, 2024
High RiskFDA
Amy's Kitchen Inc.
Amy's Kitchen Enchilada Verde Whole Meal 10 oz. 12 pk Item # 000085
Food·8,563 affected·Mar 21, 2024
High RiskFDA
Tradewind Foods De Puerto Rico Inc.
Goya Red Kidney Beans, Net Wt.15.5oz.(439g), metal (tin) cans, 24 cans/15.5 oz. per case
Food·1,349 affected·Mar 21, 2024
High RiskFDA
Apothecus Pharmaceutical Corp.
VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Pharmaceutical Corp...
Drugs·17,280 affected·Mar 21, 2024
High RiskFDA
Lupin Pharmaceuticals Inc.
Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufac...
Oral Drugs·26,352 affected·Mar 21, 2024
CriticalFDA
Amneal Pharmaceuticals Of New York, Llc
Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC ...
Oral Drugs·821 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter
Cardiac Devices·46,860 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; cardiac catheter
Cardiac Devices·290 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter
Cardiac Devices·11,109 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; cardiac catheter
Cardiac Devices·297,479 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheter
Cardiac Devices·25,617 affected·Mar 21, 2024
CriticalFDA
Sonarmed Inc
AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Medical Devices·500 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter
Cardiac Devices·15 affected·Mar 21, 2024
CriticalFDA
Sonarmed Inc
AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Medical Devices·610 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter
Cardiac Devices·116,091 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter
Cardiac Devices·1,950 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512; cardiac catheter
Cardiac Devices·8,575 affected·Mar 21, 2024