SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes17 reports about syringe on this site. See them all →, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compoun…

SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes17 reports about syringe on this site. See them all →, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Nationwide within the U.S

SERMORELIN ACETATE 1 MG/ML INJECTABLE, Packaged in single-use dosage syringes17 reports about syringe on this site. See them all →, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems.…

Sterile Eye Drops18 reports about eye drop on this site. See them all → Redness Relief (Glycerin 0.25%, Naphazoline HCl 0.02% Lubricant | Redness Reliever) (Relieves Dryness, Burning and Irritations), 0.5 fl oz (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0010-1; b) Discount drug mart, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 4…

Apothecary NAD+ Injection 200 mg/mL, 6 mL Sterile Multi-Dose Vial, Rx Only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC, 27513, NDC 85091-011-06. Reason: Lack of Assurance of Sterility Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Nationwide within the United States

BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007 Reason: Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter. Class IThe FDA's most serious recall level: a reasonable chance the product could cause serious health problems or death.…

VERIFY Biological Steam Test Pack Model/Catalog Number: S3065 Reason: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective,…

Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin2 reports about insulin on this site. See them all → Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The MiniMed Flex pump is an alternate controller enabled (ACE) pump intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. It can reliably…

Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333 (U.S. and Outside U.S.), 2. 728340 (Outside U.S.), 3. 728344 (Outside U.S.), 4. 728345 (Outside U.S.); Reason: Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in ima…

Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XWBS Reason: The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the r…

Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M Reason: Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers. Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide distribution in the states of North Carolina, and California.

Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03, 01-04, 01-05, 01-06, 02-10, 02-11, and 02-40 Product Description: The device is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility.…

Battle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL; Patrol IFAK Bag, Multicam - Advanced, REF: 81-125-MC; Patrol IFAK II, Olive Drab, Stocked (Option 1), 81-129-OD; IFAK Bag, Intermediate, Black - Stocked, 81-133-BL; IFAK Bag, Intermediate, Coyote Brown - Stocked, 81-133-CB; IFAK Bag, Intermediate, Multicam - Stocked, 81-1…

VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006 Reason: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle w…

VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061 Reason: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the stea…

Glypto Device, Glypto Cryo Machine; Reason: Lack of 510(k) clearance. Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide distribution.

VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060 Reason: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the st…

ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11; Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.

VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007 Reason: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle w…

ADULT HEART TRAY SHANDS JACKS; Model/Item Number (Kit): SHND419-08; Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.

Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M Reason: Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers. Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide distribution in the states of North Carolina, and California.

CRANIOTOMY PACK; Model/Item Number (Kit): WRNM035-20; Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.

HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control, Software Version: 2.0.18 Reason: A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could …

UROLOGY MAJOR; Model/Item Number (Kit): WRNM058-10; Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.

ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A Reason: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions Class IIIThe lowest FDA recall level: unlikely to cause health problems, but it breaks the rules. · Ongoing · Worldwide - Nationwide and the country of Canada.

DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28; Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.

Sterile Lubricant Dry Eye Relief Eye Drops18 reports about eye drop on this site. See them all →, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; b) Crocodile Tears, Distributed by: Crocodile Tears, Palm Beach Gardens, FL 33410, UPC: 8 67166 00000 4; c) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC: 0 93351 01156 6;…

VERIFY Biological Steam Test Pack Model/Catalog Number: S3069 Reason: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective,…

QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes17 reports about syringe on this site. See them all →, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Nationwide with…

Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XWS Reason: The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from th…