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Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.

FDA Recall
Terminated ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code QAN·November 19, 2021

MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)

FDA Recall
Open, Classified ·PATH Landsberger Str. 65 Germering Germany·Product code GWJ·November 6, 2025

POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N

FDA Recall
Open, Classified ·SURGICAL SPECIALTIES·Product code GAM·March 26, 2024

Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090

FDA Recall
Open, Classified ·Medtronic Inc.·Product code QAN·February 16, 2024

Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011

FDA Recall
Terminated ·Clinical Diagnostic Solutions, Inc.·Product code GKZ·January 2, 2020

Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090

FDA Recall
Open, Classified ·Medtronic Inc·Product code QAN·December 4, 2025

Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.

FDA Recall
Terminated ·Medtronic Inc.·Product code QAN·March 16, 2021

Smith & Nephew Endoscopic Disposable Blades: NOTCHBLASTER ABR,EP-1,5.5 DSPL Part #: 7205329. DYONICS Series 3000 BONECUTTER Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty.

FDA Recall
Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code NBH·May 7, 2009

MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2) GYN VAGINAL, Medline Kit Number/SKU DYNJ912219; 3) KIT MAJ VAG SET UP, Medline Kit Number/SKU DYNJ907033B; 4) MINOR VAG PACK, Medline Kit Number/SKU DYNJ68663B; 5) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099F; 6) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099G; 7) OB PACK, Medline Kit Number/SKU DYNJ03387B; 8) OB PACK, Medline Kit Number/SKU DYNJ03387C; 9) OB PACK, Medline Kit Number/SKU DYNJ53543B; 10) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645D; 11) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645F; 12) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645G; 13) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454K; 14) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454L; 15) VAGINAL PACK, Medline Kit Number/SKU DYNJ01830G.

FDA Recall
Open, Classified ·Product code MLS·May 4, 2026

Suction Instrument with Tubing, Catalog No. 302. Instrument: Yankauer without Vent. *Tubing: 6'' x 1/4'' I.D. Non-Conductive. Sterile, Single Use, Latex Free. Rx ONLY. Packaged and Sterilized in the U.S.A. *Tubing Made in Mexico. busse Hospital Disposables Hauppauge, NY 11788. --- Classification Name: Unit, Suction Operatory. Class I device, 510(k) exempt, Device Listing Number A715729. Product comprises 2 components: a Yankauer made from K-Resin and tubing made from PVC. Each instrument is packed in a flexible packaging comprising Tyvek(R) and plastic film. There are 20 units per shipping carton.

FDA Recall
Terminated ·Busse Hospital Disposables·Product code EBR·April 13, 2004

Suction Instrument with Tubing, Catalog No. 305. Instrument: Yankauer without Vent. *Tubing: 10'' x 1/4'' I.D. Non-Conductive. Sterile, Single Use, Latex Free. Rx ONLY. busse Hospital Disposables Hauppauge, NY 11788. --- Classification Name: Unit, Suction Operatory. Class I device, 510 (k) exempt, Device Listing Number A715729. Product comprises 2 components: a Yankauer made from K-Resin and tubing made from PVC. Each instrument is packed in a flexible packaging comprising Tyvek(R) and plastic film. There are 20 units per shipping carton.

FDA Recall
Terminated ·Busse Hospital Disposables·Product code EBR·April 13, 2004

Spacelabls Medical, Ultraview Multigas Analyzer, Model 91518,Spacelabs Healthcare, Issaquah, WA, 98027

FDA Recall
Terminated ·Spacelabs Healthcare, Incorporated·Product code CBR·October 8, 2007

Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits.

FDA Recall
Terminated ·Spacelabs Healthcare Inc·Product code CBR·June 18, 2014

Suction Instrument with Tubing, Catalog No. 303. Instrument: Yankauer with Vent. *Tubing: 6'' x 1/4'' I.D. Non-Conductive. Sterile, Single Use, Latex Free. Rx ONLY. *Tubing Made in Mexico. busse Hospital Disposables Hauppauge, NY 11788. --- Classification Name: Unit, Suction Operatory. Class I device, 510 (k) exempt, Device Listing Number A715729. Product comprises 2 components: a Yankauer made from K-Resin and tubing made from PVC. Each instrument is packed in a flexible packaging comprising Tyvek(R) and plastic film. There are 20 units per shipping carton.

FDA Recall
Terminated ·Busse Hospital Disposables·Product code EBR·April 13, 2004

SS 4.5MM DIAMOND TIP TROCAR WITH LARGE GLOVES Catalog Number:B1559

FDA Recall
Terminated ·Busse Hospital Disposables, Inc.·Product code FBR·February 22, 2022

Ultraview Spacelabs Medical Multigas Analyzer, Model 91518, V1.00.14. Spacelabs Healthcare Llc. Monitors gas concentrations and alerts clinical personnel when the concentration of anesthetic agents, oxygen, carbon dioxide, or nitrous oxide falls outside of defined limits. The anesthetic agent being administered is automatically identified.

FDA Recall
Terminated ·Spacelabs Healthcare, Llc·Product code CBR·June 8, 2011

Trumpf Universal Imaging Extension (OEM) Catalog NUmber: F-PMT-A2

FDA Recall
Terminated ·The OR Group·Product code FPS·November 6, 2003

Ronci Surgical Universal Imaging Extension used with the Ronci Pain Management Table System Catalog Number: R-934-25A

FDA Recall
Terminated ·The OR Group·Product code FPS·November 6, 2003

Stryker Universal Imaging Extension (OEM) Catalog Number: R--934-TRIO-A1

FDA Recall
Terminated ·The OR Group·Product code FPS·November 6, 2003

Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (Tao Brush), 9.0Fr/26 cm, 3.5 cm, sterile, Cook Ob/Gyn, Spencer, IN; REF J-ES-090500-BL. Used to obtain endometrial samples for both cytology and histology. Intended for one-time use.

FDA Recall
Terminated ·Cook OB/Gyn, Inc.·Product code HFE·April 2, 2009