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
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an interactive displ...
Cardiac Devices·1 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP; the system utilizes an interactive disp...
Cardiac Devices·5 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system utilizes an interactive disp...
Cardiac Devices·92 affected·Sep 5, 2024
High RiskFDA
Olympus Corporation Of The Americas
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
Surgical Devices·279 affected·Sep 4, 2024
High RiskFDA
Leica Biosystems Nussloch Gmbh
Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for fre...
Medical Devices·25 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF...
Medical Devices·197 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c)...
Medical Devices·1,048 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b) TRAY FOL LATX U...
Medical Devices·8,830 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit
Medical Devices·15 affected·Sep 4, 2024
High RiskFDA
Bard Peripheral Vascular Inc
The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refl...
Surgical Devices·222,373 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit
Medical Devices·165 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT,...
Cardiac Devices·2,631 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion OB TRAY, REF MNS13965A; medical procedure convenience kit
Medical Devices·30 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
Medical Devices·160 affected·Sep 4, 2024
High RiskFDA
Leica Biosystems Nussloch Gmbh
Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples
Medical Devices·1 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit
Medical Devices·144 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND/FOOT CDS, REF CD...
Medical Devices·2,371 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ22354L; 3) EYE PACK...
Medical Devices·27,906 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1...
Medical Devices·320 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit
Medical Devices·90 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit
Medical Devices·90 affected·Sep 4, 2024
High RiskFDA
Howmedica Osteonics Corp.
Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and r...
Medical Implants·16 affected·Sep 4, 2024
High RiskFDA
B-k Medical A/s
bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery...
Medical Devices·1,648 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit
Surgical Devices·1,180 affected·Sep 4, 2024
High RiskFDA
Leica Biosystems Nussloch Gmbh
Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, d) 1491850UVUL; ...
Medical Devices·322 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit
Medical Devices·22 affected·Sep 4, 2024
High RiskFDA
Leica Biosystems Nussloch Gmbh
Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03; for ...
Medical Devices·187 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J; 2) HH PACK SONICATION SPEC CONTAI, ...
Cardiac Devices·22,327 affected·Sep 4, 2024
High RiskFDA
Leica Biosystems Nussloch Gmbh
Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue sam...
Medical Devices·13 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenience kit
Medical Devices·30 affected·Sep 4, 2024
High RiskFDA
Leica Biosystems Nussloch Gmbh
Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US; for fre...
Medical Devices·30 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH PACK-LF, REF DYN...
Cardiac Devices·1,460 affected·Sep 4, 2024
High RiskFDA
Blue Tape Sriracha
Blue Tape Sriracha sauce is refrigerated condiment, packaged in a 10.5oz clear squeeze bottle, sold individually. Ingredients: Chilies, ...
Food·136 affected·Sep 3, 2024
High RiskFDA
Ascend Laboratories, Llc
Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA; D...
Oral Drugs·117,493 affected·Sep 3, 2024
High RiskFDA
Vivier Pharma, Inc.
Vivier Sheer SPF 30 Mineral With Antioxidants (titanium dioxide 10% and zinc oxide 8%) packaged in 60 ml/2 fl oz, Vivier Canada Inc. / Mf...
Drugs·3,476 affected·Sep 3, 2024
CriticalFDA
Datex--ohmeda, Inc.
GE Heathcare Giraffe OmniBed; neo natal incubator
Medical Devices·0 affected·Sep 3, 2024
RecallFDA
Trackx Technology Inc
Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate...
Surgical Devices·82 affected·Sep 3, 2024
High RiskFDA
Philips North America Llc
Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal struc...
Diagnostic Devices·33 affected·Sep 3, 2024
High RiskFDA
Philips North America Llc
Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal...
Diagnostic Devices·64 affected·Sep 3, 2024
High RiskFDA
Philips North America Llc
Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal st...
Diagnostic Devices·8 affected·Sep 3, 2024
High RiskFDA
Philips North America Llc
Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the inte...
Diagnostic Devices·3 affected·Sep 3, 2024
High RiskFDA
Philips North America Llc
SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spect...
Diagnostic Devices·14 affected·Sep 3, 2024
High RiskFDA
Philips North America Llc
Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal s...
Diagnostic Devices·33 affected·Sep 3, 2024
High RiskFDA
Philips North America Llc
SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of t...
Diagnostic Devices·32 affected·Sep 3, 2024
High RiskFDA
Philips North America Llc
Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal...
Diagnostic Devices·63 affected·Sep 3, 2024
High RiskFDA
Philips North America Llc
Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal struct...
Diagnostic Devices·48 affected·Sep 3, 2024
High RiskFDA
Philips North America Llc
SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of ...
Diagnostic Devices·2 affected·Sep 3, 2024
High RiskFDA
Sin Sistema De Implante Nacional S.a
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Medical Implants·123 affected·Sep 1, 2024