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    Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0 Product Description: TBS iNsight is a class II Medical Device software that is installed on bone densitometers for analysis of bone microarchitecture and bone health management Component: No

    FDA Recall
    Open, Classified ·Medimaps Group Fongit Chemin des Aulx 18 Plan-les-Ouates Switzerland·Product code KGI·February 3, 2025

    BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis CII Safe ES, Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code BRY·April 5, 2023

    ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)

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

    Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO

    FDA Recall
    Open, Classified ·Southmedic, Inc.·Product code GES·October 27, 2022

    Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.

    FDA Recall
    Open, Classified ·INCIPIO DEVICES avenue des Paquiers 16 St-Blaise Switzerland·Product code HWA·October 30, 2024

    Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW

    FDA Recall
    Open, Classified ·SPINEART SA Chemin Du Pre-Fleuri 3 Plan-Les-Ouates Switzerland·Product code NKB·June 30, 2025

    JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S; JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE LARGE, REF: JLT-PL 04 08-S, JLT-PL 04 10-S, JLT-PL 04 12-S, JLT-PL 04 14-S, JLT-PL 04 16-S, JLT-PL 04 18-S

    FDA Recall
    Open, Classified ·SPINEART SA Chemin Du Pre-Fleuri 3 Plan-Les-Ouates Switzerland·Product code OVD·March 16, 2023

    Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW Component: No

    FDA Recall
    Open, Classified ·SPINEART SA Chemin Du Pre-Fleuri 3 Plan-Les-Ouates Switzerland·Product code NKB·June 30, 2025

    PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S TLF-DS 55 35-S TLF-DS 55 40-S TLF-DS 55 45-S TLF-DS 65 35-S TLF-DS 65 40-S TLF-DS 65 45-S TLF-DS 65 50-S The PERLA TL system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (painful degeneration of the disc), spondylolisthesis, trauma, spinal stenosis, deformities (i.e. scoliosis, kyphosis, or lordosis), tumor and failed previous fusion (pseudarthrosis).

    FDA Recall
    Open, Classified ·SPINEART SA Chemin Du Pre-Fleuri 3 Plan-Les-Ouates Switzerland·Product code NKB·March 15, 2024

    Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)

    FDA Recall
    Open, Classified ·Withings 37 Bis Rue Du General Leclerc Issy les Moulineaux CEDEX France·Product code DPS·December 19, 2022

    Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Description: CELSITE BABYPORT SET PUR 4,5F IV USA Component: N/A

    FDA Recall
    Open, Classified ·B.Braun Medical S.A.S. Celsa Lg Medical 30 avenue des Temps Modernes; Cs 10031 Chasseneuil du Poitou CEDEX France·Product code LJT·July 21, 2025

    Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Catalog Numbers LCA 10 - ARD2LCA00040C, LCA 10 - ARDLCA109000C, LCA 10 - ARDLCA109002C, LCA 10 - ARDLCA109006C, LCA 10 - ARDLCA209008A, LCA 10 - ARDLCA209008C, LCA 10 - ARDLCA209009A, LCA 10 - ARDLCA209009C, LCA 10 - ARDLCA209010A, LCA 10 - ARDLCA209010C, LCA 10 - ARDLCA409000C, LCA 10 - ARDLCA409001C, LCA 10 - ARDLCA409002A, LCA 10 - ARDLCA409002C, LCA 10 - ARDLCA409003C, LCA 10 - ARDLCA409004A, LCA 10 - ARDLCA409004C, LCA 10 - ARDLCA409005C, LCA 10 DES - ARDLCA409001A, LCA 10 MOBILE - ARDLCA309008A, LCA 10 RAIL - ARDLCA409005A, LCA 10 WALL - ARDLCA109006A, LCA 40 - ARDLCA109001C, LCA 40 - ARDLCA208000A, LCA 40 - ARDLCA208000C, LCA 40 - ARDLCA208001A, LCA 40 - ARDLCA208001C, LCA 40 - ARDLCA209000A, LCA 40 - ARDLCA209000C, LCA 40 - ARDLCA209001A, LCA 40 - ARDLCA209001C, LCA 40 - ARDLCA209002A, LCA 40 - ARDLCA209002C, LCA 40 - ARDLCA209003A, LCA 40 - ARDLCA209003C, LCA 40 - ARDLCA209014A, LCA 40 - ARDLCA209014C, LCA 40 - ARDLCA209017A, LCA 40 - ARDLCA209017C, LCA 40 - ARDLCA209018A, LCA 40 - ARDLCA209018C, LCA 40 - ARDLCA209019A, LCA 40 - ARDLCA209019C, LCA 40 - ARDLCA209020A, LCA 40 - ARDLCA209020C, LCA 40 - ARDLCA209021A, LCA 40 - ARDLCA209021C, LCA 40 MOBILE - ARDLCA309009A, LCA 40 WALL - ARDLCA109001A, LCA 40GS - ARDLCA109009A, LCA 40GS - ARDLCA109009C, LCA 100 - ARDLCA109005A, LCA 100 - ARDLCA109005C, LCA 100 - ARDLCA219000A, LCA 100 MOBILE - ARDLCA309006A, LCA 100 MOBILE B - ARDLCA309007A, LCA 100 SAT - ARDSAT209004A, LCA 100 SAT - ARDSAT209005A, LCA 100 V - ARDLCA219000C, LCA 100DF - ARDLCA109008A, LCA 100DF - ARDLCA109008C, LCA 100DF - ARDLCA219003A, LCA 100DF - ARDSAT209008A, LCA 100DF - ARDSAT209009A, LCA 100DF V - ARDLCA219003C, LCA 50 - ARDLCA109004A, LCA 50 - ARDLCA109004C, LCA 50 - ARDLCA209012A, LCA 50 - ARDLCA209012C, LCA 50 - ARDSAT209002A, LCA 50 MOBILE - ARDLCA309004A, LCA 50 MOBILE B - ARDLCA309005A, LCA 50 SAT - ARDSAT209003A, LCA 50 WALL 11 - ARD2LCA00140A, LCA 50DF - ARDLCA109007A, LCA 50DF - ARDLCA109007C, LCA 50DF - ARDLCA209015A, LCA 50DF - ARDLCA209015C, LCA 50DF - ARDSAT209006A, LCA 50DF - ARDSAT209007A, LCA DUO 100 - ARDLCA219001A, LCA DUO 100 V - ARDLCA219001C, LCA DUO 100+50 - ARDLCA219002A, LCA DUO 100+50 V - ARDLCA219002C, LCA DUO 100+50DF - ARDLCA219005A, LCA DUO 100+50DF V - ARDLCA219005C, LCA DUO 100DF - ARDLCA219004A, LCA DUO 100DF V - ARDLCA219004C, LCA DUO 50 - ARDLCA209013A, LCA DUO 50 - ARDLCA209013C, LCA DUO 50DF - ARDLCA209016A, LCA DUO 50DF - ARDLCA209016C, LCA100 MOBILE UPGRADE - ARDLCA506006A, LCA100 UPGRADE - ARDLCA506004A, LCA100 UPGRADE 24V - ARDLCA506005A, LCA100 WALL UPGRADE - ARDLCA506007A, LCA50 UPGRADE - ARDLCA506000A, LCA50 UPGRADE 24V - ARDLCA506001A, LCA50 UPGRADE WALL MOUNTED - ARDLCA506003A, SAT LCA 100 - ARDSAT209004C, SAT LCA 100 - ARDSAT209005C, SAT LCA 100DF - ARDSAT209008C, SAT LCA 100DF - ARDSAT209009C, SAT LCA 50 - ARDSAT209002C, SAT LCA 50 - ARDSAT209003C, SAT LCA 50DF - ARDSAT209006C, SAT LCA 50DF - ARDSAT209007C, LCA 10 MOB - ARDLCA309000A, LCA 10 MOB - ARDLCA309000C, LCA 10 MOB - ARDLCA309002A, LCA 10 MOB - ARDLCA309002C, LCA 10 MOB - ARDLCA309008C, LCA 100 MOBILE - ARDLCA309006C, LCA 100 MOBILE B - ARDLCA309007C, LCA 40 MOB - ARDLCA309001A, LCA 40 MOB - ARDLCA309001C, LCA 40 MOB - ARDLCA309003A, LCA 40 MOB - ARDLCA309003C, LCA 40 MOB - ARDLCA309009C, LCA 40GS MOBILE - ARDLCA309010A, LCA 40GS MOBILE - ARDLCA309010C, LCA 50 MOBILE - ARDLCA309004C, LCA 50 MOBILE B - ARDLCA309005C,

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FTD·November 8, 2023