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
Acella Pharmaceuticals, Llc
NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles (NDC 42192-327-01) and b) 7-count bottles (NDC 421...
Oral Drugs·66,155 affected·Apr 29, 2021
High RiskFDA
Exact Medical Manufacturing, Inc.
Hays Ultrasound kit Item ID: H1000SE
Medical Devices·10,020 affected·Apr 29, 2021
High RiskFDA
Exact Medical Manufacturing, Inc.
6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA
Medical Devices·17,545 affected·Apr 29, 2021
High RiskFDA
Exact Medical Manufacturing, Inc.
Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576
Medical Devices·800 affected·Apr 29, 2021
High RiskFDA
Covidien, Lp
Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single use on anesthetized patients and resp...
Respiratory Devices·192,000 affected·Apr 29, 2021
High RiskFDA
Covidien, Lp
Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on anesthetized patien...
Respiratory Devices·7,200 affected·Apr 29, 2021
High RiskFDA
Exact Medical Manufacturing, Inc.
Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
Medical Devices·129,600 affected·Apr 29, 2021
High RiskFDA
Exact Medical Manufacturing, Inc.
Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N
Medical Devices·51,300 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
Medical Devices·5 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
Medical Devices·25 affected·Apr 29, 2021
High RiskFDA
Exact Medical Manufacturing, Inc.
Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664
Medical Devices·6,000 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.
Medical Devices·12 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
Medical Devices·15 affected·Apr 29, 2021
High RiskFDA
Exact Medical Manufacturing, Inc.
Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA
Medical Devices·8,800 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
Medical Devices·2 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
Medical Devices·10 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.
Medical Devices·3 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
Medical Devices·61 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.
Medical Devices·16 affected·Apr 29, 2021
High RiskFDA
Exact Medical Manufacturing, Inc.
Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N
Medical Devices·5,621 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
Medical Devices·6 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
Medical Devices·10 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
Medical Devices·15 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
Medical Devices·6 affected·Apr 29, 2021
High RiskFDA
Covidien, Lp
Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care ...
Respiratory Devices·32,625 affected·Apr 29, 2021
High RiskFDA
Exact Medical Manufacturing, Inc.
Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360
Medical Devices·500 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
Medical Devices·1 affected·Apr 29, 2021
High RiskFDA
Exact Medical Manufacturing, Inc.
Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL
Medical Devices·3,000 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.
Medical Devices·8 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.
Medical Devices·26 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
Medical Devices·14 affected·Apr 29, 2021
High RiskFDA
Exact Medical Manufacturing, Inc.
Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29
Medical Devices·36,000 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
Medical Devices·18 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.
Medical Devices·11 affected·Apr 29, 2021
High RiskFDA
Exact Medical Manufacturing, Inc.
6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA
Medical Devices·7,920 affected·Apr 29, 2021
RecallFDA
Now Health Group Inc.
NOW 4x6 Acidophilus, 60 capsules per retail bottle. Item number 2920. UPC 7 33739 02920 1
Food·10,235 affected·Apr 28, 2021
High RiskFDA
Croissant Etc Corp
6" Round Croissant Crust 100 Count Bulk, frozen, Net Weight: 6.25 lbs. Croissant Etc. Corp., Greendale, WI 53129
Frozen Food·20 affected·Apr 28, 2021
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
Drugs·48 affected·Apr 28, 2021
RecallFDA
Fresenius Medical Care Holdings, Inc.
DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451,...
Drugs·49 affected·Apr 28, 2021
RecallFDA
Fresenius Medical Care Holdings, Inc.
DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs ...
Drugs·4 affected·Apr 28, 2021
RecallFDA
Fresenius Medical Care Holdings, Inc.
DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23),...
Drugs·672 affected·Apr 28, 2021
RecallFDA
Fresenius Medical Care Holdings, Inc.
DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2...
Drugs·39 affected·Apr 28, 2021
High RiskFDA
Preferred Pharmaceuticals, Inc.
Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: ...
Drugs·147 affected·Apr 28, 2021
RecallFDA
Fresenius Medical Care Holdings, Inc.
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and ...
Drugs·285 affected·Apr 28, 2021
RecallFDA
Fresenius Medical Care Holdings, Inc.
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL Freseniu...
Drugs·5 affected·Apr 28, 2021
RecallFDA
Fresenius Medical Care Holdings, Inc.
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC...
Drugs·25 affected·Apr 28, 2021
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation...
Medical Devices·1 affected·Apr 28, 2021
High RiskFDA
Fresenius Medical Care Holdings, Inc.
(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chron...
Medical Devices·1 affected·Apr 28, 2021