39 results
·
95ms
·
Sources: EU EUDAMED, US FDA
SYNCHRON® SYSTEMS ALCOHOL (ETOH) REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code DMT·August 17, 2011
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·December 8, 2010
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·August 6, 2010
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·January 28, 2025
UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·July 26, 2011
DA VINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·May 12, 2025
CATALYS SYSTEM
FDA Adverse Event
Injury
·AMO MANUFACTURING USA, LLC·Product code OOE·December 2, 2025
EC-5000
FDA Adverse Event
Malfunction
·NIDEK CO., LTD.·Product code LZS·January 30, 2019
EC-5000
FDA Adverse Event
Malfunction
·NIDEK CO., LTD.·Product code HQF·May 18, 2016
CATALYS SYSTEM
FDA Adverse Event
Injury
·AMO MANUFACTURING USA, LLC·Product code OOE·December 2, 2025
PURPLE NITRILE EXAM GLOVE MED 500
FDA Adverse Event
Injury
·O&M HALYARD, INC.·Product code LZC·November 25, 2025
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·June 3, 2025
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·December 29, 2011
ITW Dymon Medaphene Plus Country Garden Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal, Staphylocidal, Tuberculocidal, packaged in 20-oz. steel aerosol cans, net wt 16-oz. (1-lb.), 12 cans/case, containing 0.19% o-phenylphenol and 68.00% ethyl alcohol, Product #42620. The firm name on the label is ITW Dymon, Olathe, KS. The product is also distributed under the following private labels: (1) Area Two-In-One Disinfectant Spray Country, Reorder #ADI-531, Sold By Area Distributors, Inc., Quincy, IL; (2) Lawson Fresh Air Disinfectant Spray, Product 90386, Manufactured for Lawson Products, Inc., Corporate Headquarters Des Plaines, IL; (3) Major Envirocide Country Fresh Disinfectant Spray, Sold By Major Chemical Company, Charlotte, NC; (4) Concept Potpourri Disinfectant Deodorant, Sold By Manny''s Sanitary Supplies, Inc., New Orleans, LA; (5) Meyer Century Zip Hospital Disinfectant, A Product of Meyer Laboratory, Inc., Blue Springs, MO; (6) Pro Chem Deocept Passion Hospital Disinfectant, Sold By Pro-Chem, Inc., Alpharetta, GA; (7) State Discover Aerosol Disinfectant Country Garden, Stock #109568 and and #109569, Sold By State Industrial Products, Cleveland, OH; (8) Sterling Quality Nature''s Country Garden Disinfectant Spray, Distributed By Sterling Sanitary Supply Corporation, Woodside, NY; (9) North Woods TB Plus Spray Disinfectant Spray, Sold By Superior Chemical Corp., Sheboygan, WI; (10) Renown Potpourri Disinfectant Deodorant, Product REN05056, Distributed by: AmSan, LLC, Deerfield, IL; (11) Asepsis Asepticide Disinfectant Spray, Handpiece Disinfectant, Country Garden, Distributed By Asepsis International, Inc., Depew, NY; (12) Dazzle ''D'' Disinfectant Spray Country Garden, Sold By Henry Kraft Inc., Nevada, MO; (13) TB-Cide Country Garden Hospital Disinfectant, Sold By Industrial Distributors, Inc., Huntington Station, NY; (14) G-Sep Aromatic Disinfectant Spray, Sold By Moore Research, Inc., St. Louis, MO; (15) Mt. Hood Chemical Hospit-all New Country Garden Fragrance Disinfectant Spray, Sold By Mt. Hood Chemical Corp., Portland, OR; (16) IDS Medi-Spray Country Garden Disinfectant Deodorant, Manufactured For Sold By International Distribution System, Inc., Neptune Beach, FL; (17) Neutron Country Garden Disinfectant Spray, Stock #110030, A product of Nuetron Industries, Phoenix, AZ; (18) Sunrise Environmental Scientific Disinfectant Spray Country Garden, Sold By Sunrise Environmental Scientific, Sparks, NV; (19) United Laboratories Flower Power Disinfectant Spray, United 135, Sold By United Laboratories, Inc., St. Charles, IL. One private label is packaged in a 16-oz. steel aerosol can, Watkins Sanisol Disinfectant Spray, Product 42616, Manufactured for Watkins Incorporated, Winona, MN.
FDA Recall
Terminated
·ITW Dymon·Product code LRJ·February 15, 2005
PURPLE NITRILE EXAM GLOVE MED 500
FDA Adverse Event
Injury
·O&M HALYARD, INC.·Product code LZC·November 24, 2025
ERBE APC 2
FDA Adverse Event
Injury
·ERBE ELEKTROMEDIZIN GMBH·Product code GEI·February 12, 2025
IFS
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC·Product code HNO·September 28, 2018
DIGNICAP DELTA SYSTEM
FDA Adverse Event
Injury
·DIGNITANA INC.·Product code PMC·July 23, 2021
SYSTEM 2000
FDA Adverse Event
Malfunction
·ARJOHUNTLEIGH POLSKA SP Z O.O·Product code ILJ·July 24, 2017
SYSTEM 2000
FDA Adverse Event
Malfunction
·ARJOHUNTLEIGH POLSKA SP Z O.O·Product code ILJ·July 24, 2017