BEUDAMED
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    NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·March 21, 2018

    Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·March 2, 2016

    NaturaLyte Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

    FDA Recall
    Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code KPO·September 29, 2017

    Boston Scientific BLUE MAX" 20 Balloon Dilatation Catheter, UPN M001125420 (BMQ/7-4/5.8/40, 12-542), M001125630(BMQ/9-8/5.8/40, 12-563) Made in Ireland, Ballybrit Business Park, Galway, Ireland Recommended for Percutaneous Transluminal Angioplasty of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LIT·February 18, 2010

    Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis

    FDA Recall
    Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code KPO·January 18, 2016

    BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers: 74121238, MODULAR HEAD 38 MM -8MM 74121242, MODULAR HEAD 42 MM -8MM 74121246, MODULAR HEAD 46 MM -8MM 74121250, MODULAR HEAD 50 MM -8MM 74121254, MODULAR HEAD 54 MM -8MM 74121258, MODULAR HEAD 58 MM -8MM 74121338, MODULAR HEAD 3 8MM -4 (SHORT) 74121342, MODULAR HEAD 42 MM -4 (SHORT) 74121346, MODULAR HEAD 46 MM -4 (SHORT) 74121350, MODULAR HEAD 50 MM -4 (SHORT) 74121354, MODULAR HEAD 54 MM -4 (SHORT) 74121358, MODULAR HEAD 58 MM -4 (SHORT) 74121438, MODULAR HEAD 38 MM +0 (MED) 74121442, MODULAR HEAD 42 MM +0 (MED) 74121446, MODULAR HEAD 46 MM +0 (MED) 74121450, MODULAR HEAD 50 MM +0 (MED) 74121454, MODULAR HEAD 54 MM +0 (MED) 74121458, MODULAR HEAD 58 MM +0 (MED) 74121538, MODULAR HEAD 38 MM +4 (LONG) 74121542, MODULAR HEAD 42 MM +4 (LONG) 74121546, MODULAR HEAD 46 MM +4 (LONG) 74121550, MODULAR HEAD 50 MM +4 (LONG) 74121554, MODULAR HEAD 54 MM +4 (LONG) 74121558, MODULAR HEAD 58 MM +4 (LONG)

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·January 13, 2016

    Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/30 degree. The ENDOEYE video Telescopes are used with other supporting equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·December 16, 2015

    Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable; repair cable 10mm 0/30 deg., part number W7100603

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·May 10, 2017

    Portex Adult Single Limb Anesthesia Breathing Circuit, single use, Part Numbers: 386000 and 384001. Manufactured for Sims Portex, Inc., Fort Meyers, FL, Made in Mexico.

    FDA Recall
    Terminated ·MMS Sales Corp·Product code CAI·February 21, 2005

    Circuit-Unilimb, Adult, 1M (40''), Disposable, Clean Non-sterile, Adult Anesthesia Circuit, Part Numbers DYNJAAF4000, DYNJAAF6225, and DYNJAAF6261. Manufactured for Medline Industries, Inc., Mundelein, IL 60060, Made in Mexico.

    FDA Recall
    Terminated ·MMS Sales Corp·Product code CAI·February 21, 2005

    Coaxial Rebreathing Circuit 1.5 M and 2 M, single use, Part nubers T61500 (1.5 M) and T18116 (2 M). Manufactured for GEO Logistics, Copenhagen, Denmark, Made in Mexico

    FDA Recall
    Terminated ·MMS Sales Corp·Product code CAI·February 21, 2005

    Circuit-Nexus, Adult, single use, Part Numbers: N7A110CG06, N4A100CE06, C4N0121000, 60010-1B, and 40301-1-2730. Manufactured for MMS Sales Corporation, 218 Highline Road, Pharr, Texas 78577, Made in Mexico.

    FDA Recall
    Terminated ·MMS Sales Corp·Product code CAI·February 21, 2005

    Circuit-Unilimb, Pediatric, 1M (40''), Disposable, Clean Non-Sterile, Pediatric Anesthesia Circuit, Part Number DYNJAPF4000. Manufactured for Medline Industries, Inc., Mundelein, IL 60060, Made in Mexico.

    FDA Recall
    Terminated ·MMS Sales Corp·Product code CAI·February 21, 2005

    Meridian Nexus, single use. Part Numbers: C4N00D001, 15867, 15880, 15880-30, 12000-1, 40000-1, 40200-1, 40301-1, 40301-1ML, 40301-1-13, 40301-1-13MM, 40301-1-24, 40301-1-30, 40302-1C24, 60000-1, 60201-1, 60300-M, 60301-1, 60301-1-24, 60302-1HM30-70, 60301-13042M, 72300-1-4-30-70, 72301-1, 72000-50-7589, 60301-1304042, and 72000-75. Manufactured for MMS Sales Corporation, 218 Highline Road, Pharr, Texas 78577, Made in Mexico.

    FDA Recall
    Terminated ·MMS Sales Corp·Product code CAI·February 21, 2005

    Meridian Nexus- Pediatric, single use Part Numbers 60211-1304042, 60111-1, 60111-1MN, 40111-13042, 15900, 40010-1, and 40111-1. Manufactured for MMS Sales Corporation, 218 Highline Road, Pharr, Texas 78577, Made in Mexico.

    FDA Recall
    Terminated ·MMS Sales Corp·Product code CAI·February 21, 2005

    Circuit- Matching Kit, 40'' Adult, 3L LPF, single use, Part Numbers RP640F0D0 and RP660F0D0. Manufactured for Pall Life Sciences, Ann Arbor, Michigan. Made in Mexico.

    FDA Recall
    Terminated ·MMS Sales Corp·Product code CAI·February 21, 2005

    Unilimb Circuit 40'' Bulk, single use Part Number 225-4400-300. Manufactured for MMS Sales Corporation, 218 Highline Road, Pharr, Texas 78577, Made in Mexico.

    FDA Recall
    Terminated ·MMS Sales Corp·Product code CAI·February 21, 2005

    Posey Connecting Strap/Belt, Cotton, 36" (232036). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.

    FDA Recall
    Terminated ·J T Posey Company·Product code FMQ·April 20, 2009

    Posey Connecting Strap/Belt, Cotton, 48" (232048). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.

    FDA Recall
    Terminated ·J T Posey Company·Product code FMQ·April 20, 2009

    Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only, The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.

    FDA Recall
    Terminated ·Med Tec Inc·Product code FMQ·December 11, 2014