148 results
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23ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Winco Nocturnal Elite Care Cliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities)
FDA Recall
Terminated
·Winco Mfg., LLC·Product code INN·April 2, 2015
Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities)
FDA Recall
Terminated
·Winco Mfg., LLC·Product code INN·April 2, 2015
NOCTURNAL ELITE CARE CLINER 6980(STD)/6990(X-LG) products are labeled in part: "***NOCTURNAL ELITE CARE CLINER 6980/6990***Winco***ISO 9001-2008 Certified***An infinite position recliner, independent leg rest and lay-flat all in one chair!***With lay-flat positioning and an independent leg rest, Winco's Nocturnal Elite Care Cliner provides optimal comfort for use in nocturnal dialysis, oncology, acute care and other patient care areas.***HEAT MASSAGE (Optional)***KEY FEATURES***Left side swing-arm for modified entry and ease of cleaning***User-adjustable positioning***Attendant controlled Trendelenburg foot release (on left & right side)***Left side fold down table***Right side Pivot Table***Rear push handle**Lay Flat***Hide-away foot rest***Independent leg rest***LiquiCell for added comfort***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 334474***www.wincomfg.com***". The Care Cliner is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion. Sticker with serial number is labeled in part: "***Manufactured By***Winco***Ocala, FL 34474***www.wincomfg.com*** Model No. ***Serial No.***" Note: Model 6988 is a version of the 6980 without the footplate. We have a single, but high volume customer, that requested the chair without the footplate. We put the model in the system so as to call out a specific Bill of Materials to leave off the footplate. Since it was a unique request, there is not a piece of literature for it.
FDA Recall
Terminated
·Winco Mfg., LLC·Product code INM·February 6, 2012
Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.
FDA Recall
Open, Classified
·SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain·Product code KPR·December 13, 2023
MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
FDA Recall
Terminated
·Megadyne Medical Products, Inc.·Product code GEI·May 15, 2018
Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code MHX·December 13, 2012
2000 Vascular with 30 Degree option
FDA Recall
Terminated
·Heritage Medical Products, Inc.·Product code LGX·September 2, 2016
Male Fertility Sperm Test for Home Use (Cassette)
FDA Recall
Open, Classified
·Changchun Wancheng Bio-Electron Co., Ltd.
2336, Tianwei Road
Beihu Science and Technology Development Zone
Changchun China·Product code NRF·November 22, 2025
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
FDA Recall
Open, Classified
·Changchun Wancheng Bio-Electron Co., Ltd.
2336, Tianwei Road
Beihu Science and Technology Development Zone
Changchun China·Product code JJW·November 22, 2025
S. Typhi/Para Typhi A Antigen
FDA Recall
Open, Classified
·Changchun Wancheng Bio-Electron Co., Ltd.
2336, Tianwei Road
Beihu Science and Technology Development Zone
Changchun China·Product code GPN·November 22, 2025
Menopause Test Cassette (Urine)
FDA Recall
Open, Classified
·Changchun Wancheng Bio-Electron Co., Ltd.
2336, Tianwei Road
Beihu Science and Technology Development Zone
Changchun China·Product code NGA·November 22, 2025
Vivoo pH Test
FDA Recall
Open, Classified
·Changchun Wancheng Bio-Electron Co., Ltd.
2336, Tianwei Road
Beihu Science and Technology Development Zone
Changchun China·Product code CEN·November 22, 2025
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
FDA Recall
Open, Classified
·Changchun Wancheng Bio-Electron Co., Ltd.
2336, Tianwei Road
Beihu Science and Technology Development Zone
Changchun China·Product code DFQ·November 22, 2025
Vivoo Protein Test
FDA Recall
Open, Classified
·Changchun Wancheng Bio-Electron Co., Ltd.
2336, Tianwei Road
Beihu Science and Technology Development Zone
Changchun China·Product code JIR·November 22, 2025
Vivoo Vaginal pH Test
FDA Recall
Open, Classified
·Changchun Wancheng Bio-Electron Co., Ltd.
2336, Tianwei Road
Beihu Science and Technology Development Zone
Changchun China·Product code LNW·November 22, 2025
LH One Step Ovulation Test Device (Urine)
FDA Recall
Open, Classified
·Changchun Wancheng Bio-Electron Co., Ltd.
2336, Tianwei Road
Beihu Science and Technology Development Zone
Changchun China·Product code NGE·November 22, 2025
The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone Test
FDA Recall
Open, Classified
·Changchun Wancheng Bio-Electron Co., Ltd.
2336, Tianwei Road
Beihu Science and Technology Development Zone
Changchun China·Product code JIN·November 22, 2025
LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI)
FDA Recall
Open, Classified
·Changchun Wancheng Bio-Electron Co., Ltd.
2336, Tianwei Road
Beihu Science and Technology Development Zone
Changchun China·Product code LJX·November 22, 2025
Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened collagen component. Suturable DuraGen is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes. Suturable DuraGen may be applied using either on-lay or suturing techniques depending on clinical need and surgeon preference.
FDA Recall
Terminated
·Integra LifeSciences Corporation·Product code GXQ·March 28, 2013
OneTouch SureStep Pro Test strips, for use with the OneTouch SureStep Pro Blood Glucose Meters, in 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by LifeScan Puerto Rico Medical device for quantitative measurement of glucose in whole blood for use in hospital and clinical settings. The product is also for use in quantitative measurement of glucose in venous, capillary, arterial and neonatal whole blood samples. This system can also be used by lay users at home.
FDA Recall
Terminated
·Lifescan Inc·Product code NBW·February 24, 2010