30 results
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16ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA ASL 2105 Large 8.5 x 17.5 Inch 1/EA, 24 ENCA ASL 2106 Extra-Large 9 x 20 Inch 1/EA, 24 ENCA ASL 2150 Universal 7 x 18 Inch 1/EA, 24 ENCA Medical - An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Recall
Terminated
·Owens & Minor Distribution, Inc.·Product code ILI·October 31, 2016
InteliFUSE, Drill Bit, 2.00 mm, J-Latch, QTY: 1, REF: DB.200.JL, non-sterile, 1515 Poydras st., Ste 1490, New Orleans, LA 70112, MDCI Arundel House, 1 Liverpool Gardens, Worthing, West Sussex BN11 1SL, United Kingdom Intended Use: Creating of holes for implant placement.
FDA Recall
Terminated
·Intelifuse Inc·Product code HTW·July 30, 2008
InteliFUSE, Drill Bit, 1.50 mm, J-Latch, QTY: 1, REF: DB.150.JL, non-sterile, 1515 Poydras st., Ste 1490, New Orleans, LA 70112, MDCI Arundel House, 1 Liverpool Gardens, Worthing, West Sussex BN11 1SL, United Kingdom Intended Use: Creating of holes for implant placement.
FDA Recall
Terminated
·Intelifuse Inc·Product code HTW·July 30, 2008
Posey Synthetic Leather and Biothane Waist and Wrist Restraints, Catalog Numbers: 2217SL and 2217B
FDA Recall
Terminated
·J T Posey Company·Product code FMQ·July 25, 2008
Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5022-21US and KKB5042-21US. The Encore is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for toileting, repositioning, changing of incontinence pads or wound dressings, standing practice etc. it is not intended for long periods of suspension or transportation.
FDA Recall
Terminated
·Arjo, Inc. dba ArjoHuntleigh·Product code FSA·June 29, 2012
Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5060-21US, KKB5062-21US and KKB5080-21US. The Chorus is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for toileting, repositioning, changing of incontinence pads or wound dressings, standing practice etc. it is not intended for long periods of suspension or transportation.
FDA Recall
Terminated
·Arjo, Inc. dba ArjoHuntleigh·Product code FSA·June 29, 2012
Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.
FDA Recall
Terminated
·Medtest Holdings, Inc.·Product code CIT·February 15, 2012
LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H
FDA Recall
Open, Classified
·LSL Healthcare Inc.·Product code OXQ·March 9, 2026
LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J
FDA Recall
Open, Classified
·LSL Healthcare Inc.·Product code OXQ·March 9, 2026
Biogel Skinsense N, Non-Latex, Powder-free Surgical Gloves with Biogel coating, Neoprene, Made from a synthetic Elastomer, Sterile/R, REGENT, Made in Malaysia, Regent Medical, Norcross, GA USA 30092, 1-800-843-8497, Toft Hall, Knotsford, Cheshire WA16 9PD, TEL: +44 (0) 1565 624000, Regent Medical is a Member of SSL International plc. Lot Number 01H0161 through 01H2668, sizes: 7-7 , One Pair sterile gloves packaged 50 pair per box/ 4 boxes per case/ total 200 pair per case.
FDA Recall
Terminated
·SSL Americas Inc.·Product code KGO·November 25, 2002
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H
FDA Recall
Open, Classified
·LSL Healthcare Inc.·Product code OXQ·March 9, 2026
LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
FDA Recall
Open, Classified
·LSL Healthcare Inc.·Product code OIB·March 9, 2026
LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554
FDA Recall
Open, Classified
·LSL Healthcare Inc.·Product code OVN·March 9, 2026
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit
FDA Recall
Open, Classified
·LSL Healthcare Inc.·Product code OWL·December 22, 2025
LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
FDA Recall
Open, Classified
·LSL Healthcare Inc.·Product code LRS·March 9, 2026
Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Powered patient lift is to lift and transfer a patient from one surface to another, as from a bed to a wheelchair. The device includes straps and a sling to support the patient.
FDA Recall
Terminated
·Invacare Corporation·Product code FSA·November 16, 2018
Crossfire Acetabular II Insert. Catalog No: 2041C-2642.
FDA Recall
Terminated
·Stryker Howmedica Osteonics·Product code JDL·January 9, 2004
CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3635, O.D. Size: 36mm, Neck Length: +3.5mm, Taper: SLT, Sterile R, 1 each, Rx only, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002. The CONSERVE Total Femoral Head is indicated for use in total hip arthroplasty for reduction of relief of pain and/or improved hip function in skeletally mature patients.
FDA Recall
Terminated
·Wright Medical Technology Inc·Product code JDL·May 14, 2009
DYNASTY A-CLASS POLY LINER, REF DLXP-LD36, 1 EACH, Rx ONLY, STERILE EO, GROUP D, I.D. 36 mm, LIP 15o, LINER STD, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. Product is used in total hip arthroplasty.
FDA Recall
Terminated
·Wright Medical Technology Inc·Product code JDL·June 7, 2010
G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
FDA Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JBL·April 3, 2019