EJB - BEUDAMED

Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The product is used for CT guided surgery.

FDA Recall

Terminated ·Biomet 3i, Inc.·Product code EJB·May 9, 2008

The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.

FDA Recall

Terminated ·Clinical Innovations, LLC·Product code OQY·January 5, 2015

Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO

FDA Recall

Terminated ·Clinical Innovations, LLC·Product code OQY·December 30, 2014

PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA)

FDA Recall

Terminated ·Smiths Medical ASD Inc.·Product code LJT·December 4, 2017

Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA); d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA); e. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO (1/EA); f. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO, VALVED (1/EA); g. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED (1/EA)

FDA Recall

Terminated ·Smiths Medical ASD Inc.·Product code LJT·December 4, 2017

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

Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products

FDA Recall

Terminated ·MTI Precision Products LLC.·Product code EFB·May 7, 2012

Midwest XGT High Speed Handpiece with Fiber Optics and Push Button Chuck, catalog #790000; Manufactured for DENTSPLY Professional, A Division of DENTSPLY International, 901 West Oakton Street, Des plaines, IL 60018-1884 USA

FDA Recall

Terminated ·DentSply Professional Division·Product code EFB·October 14, 2003

SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. Model Number: S10001

FDA Recall

Open, Classified ·Coltene Whaledent Inc·Product code EFB·January 20, 2023

Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the intended use is general dental actions such as removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

FDA Recall

Terminated ·Nakanishi Inc. 700 Shimohinata Kanuma Japan·Product code EFB·July 8, 2016

Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.

FDA Recall

Terminated ·Ormco/Sybronendo·Product code EJF·January 14, 2020

Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only (01)00190707017071(10)889437 (422)484

FDA Recall

Terminated ·Ortho Organizers, Inc.·Product code EJF·April 2, 2019

The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment.

FDA Recall

Terminated ·Ormco/Sybronendo·Product code EJF·April 24, 2012

Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets.

FDA Recall

Terminated ·Ultradent Products, Inc.·Product code EJF·February 8, 2013

Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.

FDA Recall

Terminated ·Ormco/Sybronendo·Product code EJF·March 25, 2014