62 results
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13ms
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Sources: EU EUDAMED, US FDA
Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code PEZ·April 9, 2021
Kit: Blood Culture. MAI Kit Part Number: 80315D
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code OFM·April 9, 2021
Kit: Injection REVIEW MAI Kit Part Number: 74736
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code OGJ·April 9, 2021
Kit: Blood Culture MAI Kit Part Number: 80076
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code OFZ·April 9, 2021
Kit: Midline Insertion DA. MAI Kit Part Number: 77981B
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code OFF·April 9, 2021
Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code PEZ·April 9, 2021
ON-Q Silver Dressing is a Antimicrobial wound dressing containing silver. It is individually wrapped in a foil pouch. Each pouch contains 1 single use 4" x 4.5" pad. There are 5 pouches per box. Ref: SD4X4.5; Part Number: IF-151023 and IF-151026. The product is labeled in parts: "***5 DRESSINGS***4 X 4.5 INCHES***REF SD4X4.5***PART NO. 5001826***ON-Q SilverDressing is a silver containing adhesive transparent polyurethane film for fixation and securement of devices to the skin as a primary contact sound dressing***MANUFACTURED BY ACRYMED***DISTRIBUTED BY I-FLOW***AcryMed, Inc Beaverton, OR 97008***". Intended for use in securing devices such as catheters to the skin. Also intended for use as a primary or secondary cover wound dressing on surgical incision sites.
FDA Recall
Terminated
·Acrymed Incorporated·Product code FRO·June 30, 2008
Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
FDA Recall
Terminated
·MTI Precision Products LLC.·Product code EFB·May 7, 2012
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 06597039, 2) 5 F Stiffened Micro-Introducer Kit, STF 5F M.I. KIT 45CM SS/SS ECHO S PG, Item Number H787065970415, Catalog No. REF 06597041 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code DYB·September 28, 2016
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Item Number H787065970655, Catalog No.REF 06597065, 2) 4 F Stiffened Micro-Introducer Kit, STF 4F M.I. KIT 45CM NT/T NON-ECHO S PG, Item Number H787065970695, Catalog No.REF 06597069 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code DYB·September 28, 2016
HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem necessary
FDA Recall
Terminated
·Terumo BCT, Inc.·Product code FMF·October 20, 2017
Cosmetic color soft contact lenses. Multiple colors which include Blue, Green, Aqua, Brown, Grey. BesCon (brand)
FDA Recall
Terminated
·My Cosmetics Inc·Product code LPL·November 13, 2002
DePuy Mitek Lupine Loop Plus w/ Orthocord DS Catalog #210709 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization.
FDA Recall
Terminated
·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MAI·October 31, 2011
DePuy Mitek Panalock Loop w/ Orthocord Catalog #222980 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization.
FDA Recall
Terminated
·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MAI·October 31, 2011
RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number: 72201805 Biodegradable suture anchor
FDA Recall
Terminated
·Smith & Nephew, Inc. Endoscopy Division·Product code MAI·August 6, 2013
TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626 Biodegradable suture anchor
FDA Recall
Terminated
·Smith & Nephew, Inc. Endoscopy Division·Product code MAI·August 6, 2013
Depuy Mitek Bioknotless Anchor with Ethibond Suture Ref No. 212728
FDA Recall
Terminated
·Depuy Mitek, a Johnson & Johnson Co.·Product code MAI·February 17, 2006
Depuy Mitek- Lupine Loop O-C violet Catalog Number: 222980 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
FDA Recall
Terminated
·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MAI·January 27, 2012
Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on the label is Hill-Rom Services Pte. Ltd., Singapore. The Monarch Airway Clearance System, Model 1000, is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physicians choice of treatment. It is indicated for patients having difficulty with secretion clearance or the presence of atelectasis caused by mucus plugging.
FDA Recall
Terminated
·HILL-ROM MANUFACTURING, INC.·Product code BYI·September 15, 2017
Depuy Mitek Bioknotless Anchor with Panacryl Suture Ref No. 212729
FDA Recall
Terminated
·Depuy Mitek, a Johnson & Johnson Co.·Product code MAI·February 17, 2006