219 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961; 3) ECONO STERILE HEGAR DILATOR 7&8MM STRL CS25Model Number 96-0962; 4) ECONO STERILE HEGAR DILATOR 5&6MM STERL CS25Model Number 96-0963; 5) ECONO STERILE HEGAR DILATOR 3&4MM STERL CS25Model Number 96-0964; 6) ECONO STERILE HEGAR DILATOR 1&2MM STERL CS25Model Number 96-0965; 7) ECONO STERILE HANK DILATOR 5.5&6MM STRL CS25Model Number 96-0966; gynecological dilators
FDA Recall
Open, Classified
·Sklar Instruments·Product code HDQ·December 3, 2024
VNVD Veronikis Neo Vaginal Dilator - Complete Set Catalog No. 270-100, VNVD Veronikis Neo Vaginal Dilator - 1.5cm Tip:Width:0.625in Catalog No. 270-115 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 2.5cm Tip:Width:0.625in Catalog No. 270-125 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 3.5cm Tip:Width:0.625in Catalog No. 270-135 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 4.5cm Tip:Width:0.625in Catalog No. 270-145 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 5.5cm Tip:Width:0.625in Catalog No. 270-155 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Partial Taper Couple: Width:0.625in - 1in Catalog No. 270-165 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Full Taper Couple: Width:0.625in - 1in Catalog No. 270-175 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Coupler 3cm Length: Width: 1in Catalog No. 270-185 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Small Base, Screw Length 2cm Tip: Width: 1in Catalog No. 270-195 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 1.5cn Tip: Width:0.625in Catalog No. 270-199 (sold individually). For use in securing open the opening during examination of the vaginal body cavity. For the Non-Surgical Neo Vagina.
FDA Recall
Terminated
·Marina Medical Instruments Inc.·Product code HDQ·April 9, 2009
Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) STERILE UTERINE DILATOR 1MM/2MM, Product Code HUD12ST; c) HEGAR UTERINE DILATOR, 5-6MM, STERILE, Product Code HUD56ST; d) HEGAR UTERINE DILATOR, 9-10MM, STERILE, Product Code HUD910ST; e) HANK UTERINE DILATOR 11" 7/8FR STERILE, Product Code I68920; f) HANK UTERINE DILATOR 11" 13/14FR STERILE, Product Code I68930
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code HDQ·February 23, 2024
VVD Veronikis Vaginal Dilator - Complete Set Catalog No. 270-000. Set Includes: VVD Veronikis Vaginal Dilator - 3cm Tip: Width: 1.00in Catalog No. 270-003 (sold individually) VVD Veronikis Vaginal Dilator - 5cm Tip: Width: 1.00in Cat No. 270-005 (sold individually) VVD Veronikis Vaginal Dilator - 7cm Tip: Width: 1.00in Catalog Np. 270-007 (sold individually) VVD Veronikis Vaginal Dilator - 1cm Spacer: Width: 1.00in Catalog No. 270-009 (sold individually) VVD Veronikis Vaginal Dilator - 2cm Spacer: Width: 1.00in Catalog No. 270-011 (sold individually) VVD Veronikis Vaginal Dilator - 7cm Coupler: Width: 1.00in Catalog No. 270-013 (sold individually) VVD Veronikis Vaginal Dilator - Small Base, Screw 4cm: Width: 1.00in Catalog No. 270-015 (sold individually) VVD Veronikis Vaginal Dilator - Large Base, Screw 4cm: Width: 1.75in Catalog No. 270-017 (sold individually). For use in securing open the opening during examination of the vaginal body cavity. for the Post-Surgical Vagina.
FDA Recall
Terminated
·Marina Medical Instruments Inc.·Product code HDQ·April 9, 2009
Acacia Catalog # 385166 Dual "Y" IV Extension Set 50cm Macro Bore, Spin Nut w/BD Q-Syte
FDA Recall
Terminated
·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009
Acacia Catalog # 385150 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte
FDA Recall
Terminated
·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009
Acacia Catalog # 385151 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte
FDA Recall
Terminated
·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009
Acacia Catalog # 385164 Tri-Extension IV Set 15cm Small Bore, Spin Nut w/BD Q-Syte
FDA Recall
Terminated
·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009
Acacia Catalog # 385165 "Y" IV Extension Set 20cm Macro Bore, Spin Nut w/BD Q-Syte
FDA Recall
Terminated
·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009
Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett Highway, Bothell, WA 98021. Pulse Doppler Imaging Systems used for diagnostic ultrasound imaging or fluid analysis of human body.
FDA Recall
Terminated
·Philips Medical Systems·Product code IYN·August 12, 2008
1488 HD 3-Chip Camera; Model Number 1488-610-122 - HD 3-Chip Camera Head with Integrated Coupler. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use.
FDA Recall
Terminated
·Stryker Endoscopy·Product code GCJ·March 5, 2013
1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, C-Mount; Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use.
FDA Recall
Terminated
·Stryker Endoscopy·Product code GCJ·March 5, 2013
Biopsy Guide Starter Kits C7-3 used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound imaging or fluid analysis of the human body.
FDA Recall
Terminated
·Philips Medical Systems·Product code IYN·May 29, 2008
Biopsy Guide Starter Kits C5-2 used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound imaging or fluid analysis of the human body.
FDA Recall
Terminated
·Philips Medical Systems·Product code IYN·May 29, 2008
Biopsy Guide Starter Kits L9-5 used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound imaging or fluid analysis of the human body.
FDA Recall
Terminated
·Philips Medical Systems·Product code IYN·May 29, 2008
MPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385151
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009
MPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385164
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009
BD Q-Syte Vial Access Adapter, 0.16 ml, REF 385108, Becton Dickinson Infusion Therapy Systems Inc.
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009
BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/hr)-0.5mL, REF 383536; BD Q-Style Luer Access Split Septum BD Vialon Material; BD Instaflash Needle Technology; Rx Only, Sterile EO. BD Nexiva closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon" catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, dual port adapter, vent plug and pre-attached BD Q-Syte Luer Access Split Septum. The needle and catheter are protected by a needle cover. A BD Q-Syte device or an end cap with protective cover is provided in the unit package. The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury. These devices have BD Instaflash" Needle Technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. Both the stabilization platform and dual port adapter are color coded to indicate catheter gauge size (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green). BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.
FDA Recall
Open, Classified
·Becton Dickinson Infusion Therapy Systems Inc.·Product code FOZ·September 8, 2021
BD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100, Becton Dickinson Infusion Therapy Systems Inc.
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009