Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
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
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
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
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
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
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
CriticalFDA
Datex--ohmeda, Inc.
GE Heathcare Giraffe OmniBed; neo natal incubator
Medical Devices·0 affected·Sep 3, 2024
CriticalFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion managemen...
Medical Devices·17 affected·Aug 30, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Medical Devices·7,428 affected·Aug 30, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Medical Devices·9 affected·Aug 30, 2024
High RiskFDA
Ge Healthcare
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b)¿¿¿¿ 2089507-129...
Medical Devices·1,500 affected·Aug 29, 2024
High RiskFDA
Tornier, Inc
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
Medical Devices·5 affected·Aug 29, 2024
High RiskFDA
Coopervision, Inc.
Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) ...
Medical Devices·2,443 affected·Aug 29, 2024
High RiskFDA
Microcare Medical
Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution...
Medical Devices·1,649 affected·Aug 29, 2024
High RiskFDA
Coopervision, Inc.
BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with pre...
Medical Devices·607 affected·Aug 29, 2024
High RiskFDA
Tornier, Inc
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Medical Devices·38 affected·Aug 29, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE KIT CV I II, REF DYNJ906071B
Medical Devices·56 affected·Aug 28, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
Medical Devices·72 affected·Aug 28, 2024
High RiskFDA
Safeguard Us Operating Llc
HAWK Advanced Hypothermia Management Set, Item Number: 59-320
Medical Devices·408 affected·Aug 27, 2024
High RiskFDA
Safeguard Us Operating Llc
HAWK Warming Grid, Item Number: 59-300
Medical Devices·655 affected·Aug 27, 2024
High RiskFDA
Safeguard Us Operating Llc
Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK Warming Grid, 2. Item Number: 59-320 HAWK Adva...
Medical Devices·567 affected·Aug 27, 2024
High RiskFDA
Nova Ortho-med Inc
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MO...
Medical Devices·1,585 affected·Aug 26, 2024
High RiskFDA
Nova Ortho-med Inc
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER M...
Medical Devices·1,886 affected·Aug 26, 2024
High RiskFDA
Wingderm Electro-optics Ltd.
Non-ablative Fractional Laser Systems, Model: WFB-01
Medical Devices·0 affected·Aug 23, 2024
High RiskFDA
Young Dental Manufacturing I, Llc
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Medical Devices·1,391 affected·Aug 23, 2024
High RiskFDA
Wingderm Electro-optics Ltd.
Diode Laser Hair Removal model: WLA-01
Medical Devices·0 affected·Aug 23, 2024
High RiskFDA
Stryker Spine
AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedur...
Medical Devices·8,589 affected·Aug 23, 2024
High RiskFDA
Olympus Corporation Of The Americas
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
Medical Devices·445 affected·Aug 23, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion...
Medical Devices·7,091 affected·Aug 22, 2024
CriticalFDA
Kinova Inc
KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco replaces the functi...
Medical Devices·949 affected·Aug 22, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722...
Medical Devices·250 affected·Aug 22, 2024
High RiskFDA
Intuitive Surgical, Inc.
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Medical Devices·144 affected·Aug 21, 2024
High RiskFDA
Olympus Corporation Of The Americas
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
Medical Devices·1,407 affected·Aug 21, 2024