24 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Inova Diagnostic Inc., NOVA Lite ANA KSL Kit Part Number: 708390. in vitro diagnostic.
FDA Recall
Terminated
·Inova Diagnostics Incorporated·Product code DHN·September 26, 2011
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
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
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
SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
FDA Recall
Terminated
·Organ Recovery Systems, Inc.·Product code KDL·December 14, 2016
Custodiol HTK Solution, 500ml bottle. 10 per carton.
FDA Recall
Open, Classified
·Dr Franz Koehler Chemie Gmbh Werner-Von-Siemens-Str. 14-28 Bensheim Germany·Product code KDL·January 9, 2024
Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code KAL·May 25, 2023
Accolade TMZF Plus Hip Stem: Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 Catalog #6020-3535 Accolade 132 Size 3.5 Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3 Catalog #3021-0435 Accolade TMZF Hip Stem #4 Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4 Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 K994366; k023105; K032300 Manufactured by " Stryker Ireland, Carrigtwohill Industrial Estate Carrington County Cork, Ireland The subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code ISL·March 1, 2011
ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed Pharmaceuticals label (10 x 1000mL bags). Disposable kidney perfusion set.
FDA Recall
Terminated
·Teva Pharmaceuticals USA, Inc.·Product code KDL·March 30, 2012
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.
FDA Recall
Terminated
·Baxter Healthcare Corp.·Product code KDL·October 12, 2016
SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073
FDA Recall
Terminated
·CSL Behring GmbH Emil-von-Behring-Str. 76 Marburg Germany·Product code CHN·June 5, 2017