66 results
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14ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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APSOF-7-4-RB, ZIMMON PANCREATIC STENT W/RADIOPAQUE BANDS, Stent Diameter: 7 FR., Length (Between Curl and Flap): 4 CM, For Use With Wilson-Cook Stent Introduction System: 7 FR. Minimum Accessory Channel Size: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
FDA Recall
Terminated
·Wilson-Cook Medical Inc·Product code FGE·July 25, 2003
STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].
FDA Recall
Open, Classified
·Ethicon, Inc. Us·Product code GAM·March 24, 2022
BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.
FDA Recall
Terminated
·Becton Dickinson & Company·Product code FMI·May 31, 2017
QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400, Manufactured for QRS Diagnostic, 14755 27th Ave North, Plymouth, MN 55447 USA. Product Usage: The Universal ECG is an Electrocardiograph Diagnostic System designed to provide measurements and interpretative statements of a patients ECG waveform. The interpreted ECG with measurements and diagnostic statements are provided to the physician on an advisory basis only, for the physician to over read and validate or change the ECG interpretation. The ECG measurements and interpretive statements may be reviewed, edited, distributed electronically or printed. No real time monitoring or alarm capability is provided.
FDA Recall
Terminated
·Qrs Diagnostic·Product code LOS·February 16, 2012
Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
FDA Recall
Terminated
·ICU Medical, Inc.·Product code KRB·October 5, 2018
CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code PRB·August 2, 2018
VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-dilutions on the VITROS 250/350 Chemistry Systems. The VITROS 250 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Microslides. The VITROS 350 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JRB·October 10, 2013
Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usage: Measures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis.
FDA Recall
Terminated
·Pulsion Medical Inc·Product code KRB·November 4, 2014
CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code PRB·August 2, 2018
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090
FDA Recall
Terminated
·ICU Medical, Inc.·Product code KRB·October 5, 2018
CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code PRB·August 2, 2018
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645
FDA Recall
Terminated
·ICU Medical, Inc.·Product code KRB·October 5, 2018
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
FDA Recall
Open, Classified
·Erbe Medical, LLC·Product code OCX·March 31, 2026
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
FDA Recall
Open, Classified
·Erbe USA Inc·Product code GEH·February 12, 2026
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use
FDA Recall
Open, Classified
·Erbe USA Inc·Product code GEH·February 12, 2026
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20325-206; Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 20325-207; ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Set for Fujifilm Scopes, REF: 20325-248; Hybrid CO2 Tubing/Cap Set for Fujinon Scopes, REF: 20325-208
FDA Recall
Open, Classified
·Erbe Medical, LLC·Product code FEQ·March 31, 2026
ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;
FDA Recall
Open, Classified
·Erbe Medical, LLC·Product code OCX·March 31, 2026
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
FDA Recall
Open, Classified
·Erbe USA Inc·Product code GEH·February 12, 2026
Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.
FDA Recall
Terminated
·Bausch & Lomb Inc Irb·Product code HNN·July 11, 2016
LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.85 (6/BOX), REF/PRODUCT CODE E7528, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
FDA Recall
Terminated
·Bausch & Lomb Inc Irb·Product code HNN·March 3, 2017