BEUDAMED
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    GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm REF 3844- Everest BiCOAG LP Scissors 5mm/45cm REF 910010PK- PKS MOLly Forceps 5mm/45cm Single-use, sterile devices intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.

    FDA Recall
    Terminated ·Gyrus Medical, Inc·Product code GEI·August 27, 2014

    Gyrus ACMI PKS Seal Open Forceps, model 915005PK, 9-3/4" Straight Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Southborough, MA 01772-2104 USA.

    FDA Recall
    Terminated ·Gyrus ACMI Corporation·Product code GEI·August 18, 2009

    Gyrus ACMI PKS Seal Open Forceps, model 915000PK, 9-3/4" Curved Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Southborough, MA 01772-2104 USA.

    FDA Recall
    Terminated ·Gyrus ACMI Corporation·Product code GEI·August 18, 2009

    Gyrus ACMI PKS Seal Open Forceps, model 915010PK, 9-3/4" Angled Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Southborough, MA 01772-2104 USA.

    FDA Recall
    Terminated ·Gyrus ACMI Corporation·Product code GEI·August 18, 2009

    Gyrus ACMI PKS Seal Open Forceps, model 3104PK, 9-3/4" straight. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.61 or greater required or the PlasmaKinetic with SuperPulse electrosurgical generator, software version 2.0 or greater or G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Southborough, MA 01772-2104 USA.

    FDA Recall
    Terminated ·Gyrus ACMI Corporation·Product code GEI·August 18, 2009

    Gyrus ACMI PKS Seal Open Forceps, model 3103PK, 9-3/4" curved. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.61 or greater required or the PlasmaKinetic with SuperPulse electrosurgical generator, software version 2.0 or greater or G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Southborough, MA 01772-2104 USA.

    FDA Recall
    Terminated ·Gyrus ACMI Corporation·Product code GEI·August 18, 2009

    Gyrus ACMI PKS Seal Open Forceps, model 3104PK, 9-3/4" angled. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.61 or greater required or the PlasmaKinetic with SuperPulse electrosurgical generator, software version 2.0 or greater or G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Southborough, MA 01772-2104 USA.

    FDA Recall
    Terminated ·Gyrus ACMI Corporation·Product code GEI·August 18, 2009

    GYRUS ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.93 or greater or the PlasmaKinetic with SuperPulse electrosurgical generator, software version 2.19A or greater or the G400 electrosurgical generator. Made in USA Gyrus ACMI, Gyrus Medical, Inc., 6655 Wedgwood Road, Suite 160, Maple Grove, MN 55311-3602.

    FDA Recall
    Terminated ·Gyrus Medical, Inc.·Product code GEI·May 15, 2006

    Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code GEI·June 9, 2021

    GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.

    FDA Recall
    Terminated ·Gyrus Medical, Inc·Product code GEI·July 24, 2013

    International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX4000-110 and AVOX4000-220

    FDA Recall
    Terminated ·International Technidyne Corp.·Product code JKS·February 13, 2008

    Histochemical PAS (Periodic Acid Schiff) Reaction Set. in vitro diagnostic. Product size configuration: Set of 4 bottles including Schiff Reagent 225mL, Light Green SF Yellowish Stain 225mL, Sodium Carbonate Solution 225mL, and Periodic Acid Solution 225mL. Each kit provides reagents sufficient for a maximum of 100 tests.

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code KKS·July 25, 2006

    G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and Dynamic Gonioscopy.

    FDA Recall
    Terminated ·Volk Optical Inc·Product code HKS·June 30, 2008

    Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS INS TIB SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·February 25, 2014

    Revanesse Versa, PN40081

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

    Minstrel (with scale) Product Usage: is a mobile passive hoist. It is intended for lifting and transporting adult residents on horizontal floors in hospitals, nursing homes or other health care facilitates. The Minstrel device aids in the lifting, transfer and lowering to safe position, of a patient. This is accomplished by placing a sling under the patient, and attaching the sling to a spreader bar that is connected to a lifting arm jig via a connection to the spreader bar that allows a swiveling up-down movement. Using battery power, an actuator then powers the lifting arm upwards so that the patient in the sling is lifted from, typically, a bed or chair.

    FDA Recall
    Terminated ·ARJOHUNTLEIGH POLSKA Sp. z.o.o. UI. KS. PIOTRA WAWRZYNIAKA 2 KOMORNIKI Poland·Product code FSA·July 28, 2014

    Tenor is a mobile passive lift, intended to be used on horizontal surfaces for lifting and transfer in hospitals, nursing homes or other healthcare facilities. Transfers with the Tenor are made indoors in the patient's room, in communal areas or in a bathroom. Tenor is meant to be used with the patient type who: sits in a wheelchair, has no capability to support themselves at all, cannot stand unsupported and is not able to bear weight (not even partially), is dependent on caregiver in most situations, is a passive resident, might be almost completely bed ridden, is often stiff and has contracted joints, and/or is totally dependent. The Tenor has a safe working load of 320 KG (705 lbs).

    FDA Recall
    Terminated ·ARJOHUNTLEIGH POLSKA SP. ZO.O. UI. KS. WAWRZYNIAKA 2 KOMORNIKI POZNAN Poland·Product code FSA·June 10, 2014

    Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102 [(01)05056097364483], BAB1007-01 [(01)05055982796255], BAB1101-01 [(01)05055982787949], BAB1102-01 [(01)05055982796156], BAB1103-01 [UDI: (01)05055982796163], BAB1107-01 [(01)05055982796187], BAB2000-01 [UDI: (01)05055982788106], BAB2101-01 [(01)05055982788007], BAB2102-01 [01)05055982796194], BAB3000-01 [(01)05055982788120], BAB3101-01 [(01)05055982788021], BAB3107-01[ (01)05055982796248], BAB5000-01 [UDI: (01)05055982788144]. and Concerto & Basic Shower Trolley Spare parts (safety catch) part no. 8451622, 8546608, S8533571-031, S8533572-031, S8533570-031 S8542201-014, S8523559-031,

    FDA Recall
    Terminated ·ARJOHUNTLEIGH POLSKA Sp. z.o.o. Ui. Ks. Piotra Wawrzyniaka 2 Komorniki Poland·Product code FSA·August 22, 2019

    Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.

    FDA Recall
    Terminated ·ARJOHUNTLEIGH POLSKA Sp. z.o.o. Ui. Ks. Piotra Wawrzyniaka 2 Komorniki Poland·Product code FNL·July 21, 2020

    Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retrofit kits) that can be installed on Citadel (model no. INDIDAA) or Enterprise (model no. INDIJAA) beds manufactured without IndiGo modules assembled at the time of manufacturing and subsequently retrofitted on the beds.

    FDA Recall
    Terminated ·ARJOHUNTLEIGH POLSKA Sp. z.o.o. Ul. Ks. Piotra Wawrzyniaka 2 Komorniki Poland·Product code FNL·June 10, 2021