19 results · 12ms · Sources: EU EUDAMED, US FDA

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Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator

FDA Recall
Open, Classified ·Abbott·Product code GXD·September 28, 2023

Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event and warns the patient to seek urgent medical care. The Guardian is an adjunct to patient recognized symptoms.

FDA Recall
Open, Classified ·Angel Medical Systems, Inc.·Product code QBI·September 1, 2023

WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code DQY·July 29, 2025

WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code DQY·July 29, 2025

WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code DQY·July 29, 2025

WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code DQY·July 29, 2025

Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients. Models: 5411/ 050, A5411/ 0300 and A5411/ 0400

FDA Recall
Open, Classified ·Agfa N.V. Septestraat 27 Mortsel Belgium·Product code IZL·February 23, 2024

ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.

FDA Recall
Open, Classified ·Stryker Howmedica Osteonics Corp.·Product code MEH·April 30, 2012

Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor

FDA Recall
Open, Classified ·TELEFLEX LLC·Product code GAD·May 25, 2023

Centurion Sterile Weitlaner Retractor, Reorder: 67315

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code GAD·April 9, 2025

Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNELL RETRACTOR (RR602), Product Code 67525; c) ST. SENN RETRACTOR 3 PRG BLUNT (ST7085), Product Code 37535

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code GAD·February 23, 2024

Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-30 G02791 CTU14.0-50-ST G02464 C-CTU14.0-30-ST G02898

FDA Recall
Open, Classified ·Cook Incorporated·Product code GCD·August 16, 2022

RadiaLux Lighted Retractor (Pink), REF: 50-101-1

FDA Recall
Open, Classified ·Medtronic Navigation, Inc.·Product code GAD·December 8, 2022

Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade

FDA Recall
Open, Classified ·SEASPINE ORTHOPEDICS CORPORATION·Product code GAD·May 17, 2024

Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor

FDA Recall
Open, Classified ·TELEFLEX LLC·Product code GAD·May 25, 2023

Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade

FDA Recall
Open, Classified ·SEASPINE ORTHOPEDICS CORPORATION·Product code GAD·May 17, 2024

Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. surgical instrument.

FDA Recall
Open, Classified ·Medagent Inc·Product code GAD·December 21, 2023

Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.

FDA Recall
Open, Classified ·Smith & Nephew, Inc.·Product code GAD·August 3, 2020

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M; 3) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267; 4) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267A; 5) ECONO STERILE SENN RETR DE SH 6.25"STRLCS/25, Model Number 96-2269A; 6) ECONO STERILE MINI HOHMANN 6MM 6.5" STERCS25, Model Number 96-2959; retractors

FDA Recall
Open, Classified ·Sklar Instruments·Product code GAD·December 3, 2024