BEUDAMED
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    Aneroid Kits

    FDA UDI
    RASHMAN CORPORATION·00786511248079·BP-LPK & CLINCIAL LITE W/CASE-CB

    Aneroid (82 etc)

    FDA UDI
    RASHMAN CORPORATION·00786511247638·PREMIUM ANEROID BP-LPK W/CASE-BX

    Aneroid (82 etc)

    FDA UDI
    RASHMAN CORPORATION·00786511247676·PREMIUM ANERIOD BP-LPK-CL

    Aneroid (82 etc)

    FDA UDI
    RASHMAN CORPORATION·00786511247553·PREMIUM ANEROID BP-LPK-BX

    UHP Color Cap

    FDA UDI
    Advanced Bionics, LLC·07630016811371·Princess Pink

    Aneroids (82 etc.)

    FDA UDI
    RASHMAN CORPORATION·00786511247515·NYLON CUFF W/2-TUBE BLADDER-LPK-BULK

    Aneroids (82 etc.)

    FDA UDI
    RASHMAN CORPORATION·00786511247591·ANEROID BP-LPK W/CASE-BULK

    PURITAN-BENNETT

    FDA Adverse Event
    Injury ·PURITAN-BENNETT·Product code CBK·July 28, 1997

    MASUNAGA since 1905

    FDA UDI
    MASUNAGA OPTICAL MFG.CO.,LTD.·04582644463121·

    OSSIX BONE

    FDA Adverse Event
    Injury ·Product code LPK·July 22, 2021

    COPIOS CANCELLOUS XENOGRAFT PARTICLES

    FDA Adverse Event
    Injury ·RTI SURGICAL, INC·Product code LPK·June 16, 2016

    COPIOS CANCELLOUS XENOGRAFT PARTICLES

    FDA Adverse Event
    Injury ·RTI SURGICAL, INC·Product code LPK·June 16, 2016

    MINEROSS

    FDA Adverse Event
    Injury ·ACE SURGICAL·Product code LPK·February 14, 2025

    ICESEED NEEDLE

    FDA Adverse Event
    Death ·BTG YOKNEAM·Product code GEH·September 29, 2025

    Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB000525 5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP000425 4.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP000525 5.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMSB0110 1PK PHANTOM FIBER SZ 2 WHITE SMSB0110N lPK BIOFIBER SUTURE SZ 2 WHT NEEDLED SMSB0112 10 PK PHANTOM FIBER SZ 2 WHITE SMSB0112N 10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED SMSB0120 1PK PHANTOM FIBER SZ 2 VIOLET SMSB0120N lPK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB0122 10 PK PHANTOM FIBER SZ 2 VIOLET SMSB0122N 10 PK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB0130 1PK PHANTOM FIBER SZ 2 WHITE/VIOLET SMSB0132 10 PK PHANTOM FIBER SZ 2 WHITE/VIOLET Indications for use for the Phantom Fiber are: Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

    FDA Enforcement
    Class II ·Terminated·Tornier, Inc·April 25, 2018

    Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB000525 5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP000425 4.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP000525 5.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMSB0110 1PK PHANTOM FIBER SZ 2 WHITE SMSB0110N lPK BIOFIBER SUTURE SZ 2 WHT NEEDLED SMSB0112 10 PK PHANTOM FIBER SZ 2 WHITE SMSB0112N 10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED SMSB0120 1PK PHANTOM FIBER SZ 2 VIOLET SMSB0120N lPK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB0122 10 PK PHANTOM FIBER SZ 2 VIOLET SMSB0122N 10 PK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB0130 1PK PHANTOM FIBER SZ 2 WHITE/VIOLET SMSB0132 10 PK PHANTOM FIBER SZ 2 WHITE/VIOLET Indications for use for the Phantom Fiber are: Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

    FDA Recall
    Terminated ·Tornier, Inc·Product code NWJ·February 8, 2018

    X-COATED H/L PK W/FX15RW40 Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·July 4, 2012

    X-COATED H/L PK W/FX15RW40 Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWF·May 9, 2012

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220; b) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1773; c) PERI NEURO BLOCK PACK-LF, Model Number DYNJ51107B; d) PERI NEURO BLOCK PACK-LF, Model Number DYNJ0703127A; e) PERI NEURO BLOCK PACK-LF, Model Number DYNJ42367B; f) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1571; g) CVOR ANGIOGRAPHY PACK-LF, Model Number DYNJRA0656A; h) CVOR ANGIOGRAPHY PACK-LF, Model Number DYNJ47338; i) BLOCK KIT-LF, Model Number DYNJRA1287A; j) BLOCK KIT-LF, Model Number PAIN1622A; k) BLOCK KIT-LF, Model Number DYNJRA1543; l) PK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1635A; m) PK, RADIOLOGY-NEURO-IR, Model Number DYNJ0134147D; n) PK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1604; o) BLOCK TRAY, Model Number PAIN1182;

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OGJ·May 18, 2023

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL LINE INSERT KIT W/O CA, Model Number: CVI3755; b. CENTRAL LINE KIT, Model Number: DYNDC2582, DYNDC2582A; c. CENTRAL LINE PACK-COMPANION, Model Number: DYNJ47215D; d. CENTRAL LINE TRAY, Model Number: DYNJ42902B; e. CENTRAL LINE UNIVERSAL INSERTION, Model Number: CVI3780; f. CLOSURE PACK, Model Number: DYNJ83054A; g. DBD-PICC LINEPACK PCLUI642-LF, Model Number: DYNJ47717A; h. ER CENTRAL LINE KIT, Model Number: P155508B, P155508C; i. HEMODIALYSIS CENTRAL LINE, Model Number: DYNJ63347; j. LINE KIT, Model Number: DYNJ47987A; k. PEDIATRIC CENTRAL LINE KIT, Model Number: DYNJ38885B; l. PK CUST CENTRAL LINE PACK, Model Number: DYNJ60586; m. TRAY LACERATION, Model Number: DYNDL1134A; n. TUNNEL LINE PACK, Model Number: DYNJ67990; o. ULTRASOUND GUIDED IV/MIDLINE K, Model Number: DYNDV2385;

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023