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Sources: EU EUDAMED, US FDA
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CI healthcare***Model: CI8092***S/N: 5-60-85-044 MFD: JUN, 2010 MADE IN CHINA***cihealthcare.com This stainless steel stretcher is used for transporting patients.
FDA Recall
Terminated
·Cardiopulmonary Instrumentation, Inc·Product code FPO·February 17, 2011
Bayer brand Technicon RA/opeRA Systems ISE Fluid Pack for in vitro diagnostic use on the opeRA system only, Manufacturer part number T01-3606-01, Mfd for Bayer Corporation, 511 Benedict Ave, Tarrytown, NY., Roche part number 03361322001.
FDA Recall
Terminated
·Roche Diagnostics Corp.·December 21, 2004
BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations.
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·March 16, 2017
LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code HIS·January 14, 2013
Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washed spermatozoa into the uterine cavity.
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code MFD·February 28, 2020
Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
FDA Recall
Terminated
·Ziehm Imaging Inc·Product code OWB·November 21, 2013
Lasik Custom Pak containing 1 dual tip irrigator, 8 ports, 16 G, 2 packs spears, eye, ocucel, 5S, PVA, 1 cover, support, tray 2.2MIL 6FD, and 2 dressings, tegaderm, 2 3/8 x 2 3/4. All contents considered sterile unless package is opened or damaged.RX Only. Part number 10162-01. (The Vidaurri LASIK Flap Irrigators are included in the firm''s Alcon Custom Pak Part Number 10162-01 under the description of dual tip irrigator, 8 ports, 16G.)
FDA Recall
Terminated
·Alcon Research, Ltd·Product code LQJ·September 2, 2005
Salivart Oral Moisturizer, packaged in 2.5 fluid ounce (73.9 mL) spray cans, Part Number: 0386-0009-75; Manufactured by Gebauer Company, Cleveland, Ohio
FDA Recall
Terminated
·Gebauer Company·Product code LFD·January 19, 2007
Salvart Oral Moisturizer, 2.5 fl.oz. aerosol cans, OTC, Item Number 0386-0009-75. Distributed by: Gebauer Co., Cleveland, OH.
FDA Recall
Terminated
·Gebauer Co·Product code LFD·February 23, 2004
The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code GFD·May 7, 2013
Zimmer Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 . Width plates is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code GFD·July 4, 2016
CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H25 The CelluTome Epidermal Harvesting System is intended to reproducibly cut a thin skin graft for autologous skin grafting.
FDA Recall
Terminated
·KCI USA, INC.·Product code GFD·November 19, 2014
Zimmer Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code GFD·July 4, 2016
Zimmer Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code GFD·July 4, 2016
Zimmer Air Dermatome, Model/Catalog Number: 00880100100
FDA Recall
Open, Classified
·Zimmer Surgical Inc·Product code GFD·November 24, 2025
Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
FDA Recall
Open, Classified
·RECORDATI RARE DISEASES INC.·Product code LFD·June 11, 2025
Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be under the supervision of trained personnel.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code GFD·August 4, 2020
Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code GFD·May 7, 2013
Zimmer Air Dermatome II, REF 00-8851-001-01 handpiece, w/o hose, Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities.
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code GFD·May 7, 2013
Zimmer Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope.
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code GFD·July 4, 2016