BEUDAMED
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    Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Product Usage: Expression is labelled as an Intranasal Splint, intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. However, Expression is currently being used off-label as a subcutaneously injected dermal filler.

    FDA Recall
    Terminated ·Enhancement Medical, LLC·Product code LMH·August 7, 2013

    Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.

    FDA Recall
    Terminated ·Merz North America, Inc.·Product code LMH·October 26, 2015

    Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

    FDA Recall
    Terminated ·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code LMH·February 26, 2015

    Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds.

    FDA Recall
    Terminated ·Merz North America, Inc.·Product code LMH·May 20, 2016

    MERZ AESTHETICS, Radiesse Volume Advantage 1.5 CC, Injectable Implant, Part Number 8071M0H1 and 8071M0K1, Sterile, Rx ONLY. Part Number 8071M4K1 distributed in Canada Part Number 8071M5 distributed in Europe/Middle East/Africa Part Number 8071M9 distributed in Hong Kong, Korea, Malaysia.

    FDA Recall
    Terminated ·Merz Aesthetics, Inc.·Product code LMH·August 18, 2011

    Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam, Use Before 2013-01, Ref 8046M7, Lot 1024417, Manufactured by: BioForm Medical Inc, 4133 Courtney Rd #10 Franksville, WI 53126. Subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as masolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.

    FDA Recall
    Terminated ·Merz Aesthetics, Inc.·Product code LMH·April 6, 2011

    Revanesse Versa, PN40081

    FDA Recall
    Terminated ·Prollenium Medical Technologies Inc. 138 Industrial Pky N Aurora Canada·Product code LMH·November 15, 2018

    Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers: ASK-01451-BMH; ASK-05041-CHC; ASK-05041-CHC1; ASK-05041-CHM; ASK-05041-HMC; ASK-05041-QV; ASK-07041-BMH; CN-05041-LW; MSO-01451-UCL; MTO-01451-RH; PL-05041; PR-04041-HPX; PR-05041; PR-05041-HP; PR- 05041-HPX; PR-05041-LW; PR-05041-MW; PR-05041-T; PR-05042; PR-05541-HPX; PR-07041-PTSP; and RJ-01451-W.

    FDA Recall
    Terminated ·Arrow International Inc·Product code LJS·March 29, 2010

    CALM software, version 02.09.01 This software is intended for use as a central monitoring system with signal analysis and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.

    FDA Recall
    Terminated ·LMS Medical Systems Ltd·Product code HGM·January 11, 2005

    LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment

    FDA Recall
    Terminated ·LMA North America Inc·Product code BTR·May 23, 2012

    LMA- Unique Laryngeal Mask Airway Size 4, Catalog No. 12140, Lot FH041202 Size 4, Catalog No. 12150, Lot FJ021202

    FDA Recall
    Terminated ·LMA North America Inc·Product code CAE·June 18, 2003

    LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment

    FDA Enforcement
    Class II ·Terminated·LMA North America Inc·July 25, 2012

    BHM Reacher for Portable Ceiling Lifts; a portable ceiling lift accessory used to connect the lift to the BHM Track or KwikTrak Trolley; Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. The reacher comes in two models: part #700.08310 - 24'' handle length, and part #700.08320 - 36'' handle length

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·November 13, 2006

    Medi-Lifter III Plus Total Lift, Model 7000-2000 and Summit Total Lift, Model 4800-2000; patient lifts with mast scale (600 lbs. capacity); Mast scale is Intended to be used for weighing patients while in the lifter. Manufactured by Medi-Man Rehabilitation Products Inc., 6200A Tomken Road, Mississauga, Ontario, Canada L5T 1X7, now owned by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·April 10, 2008

    BHM Kwiktrak Fixed Gate component of the Kwiktrak rail system used with the Maxi Sky 600 Ceiling Patient Lift; Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. The fixed gate, part #700.11550, was sold in two kits: a) Part #700.11500 Kwiktrak Gate Kit composed of the fixed gate and a 3-contact interface kit part #700.15515, and b) Part #700-11505 Double Gate Kit composed of two fixed gates and 3-contact interface kits

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·October 23, 2006

    Kwiktrak Gate System; the rail system used with the Maxi Sky 600 Ceiling Patient Lift; The Kwiktrak Gate System consists of part 700.11560 - Kwiktrak gate motor box (serialized), part 700.11550 - Kwiktrak gate fixed box, part 700.11505 - Kwiktrak gate combination kit (includes 2 x 700.11550 and 2 x 700.11560), and part 700.11500 - Kwiktrak gate (includes 1 x 700.11550 and 1 x 700.11560) Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. The equipment is intended for transferring lifts from one system track to another.

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·August 1, 2008

    CURATION KIT - CUSTOMED- (10) GAUZE SPONGE 4" X 4" 16PL Y (4) ABSORBENT TIP APPLICATOR (4) PVP PREP SOLUTION 1 oz (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (2) EXAM GLOVES MEDIUM (1) WRAPPER 24" X 24" UF (1) PACKING TRAY EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code FMH·May 20, 2014

    Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits

    FDA Recall
    Terminated ·Discus Dental LLC·Product code LBH·October 24, 2014

    Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing.

    FDA Recall
    Terminated ·Thermo Fisher Scientific (Monterrey) Blvd Apodaca 500 Apodaca Technology Park Apodaca Nuevo Leon 66600 Mexico·Product code FMH·April 29, 2020

    Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I prep pads are packed into each urine collection kit carton along with a pre-connected drainage funnel, specimen container, funnel lid, specimen lid and a room label.

    FDA Recall
    Terminated ·Bard Medical Division·Product code FMH·March 21, 2018