Recalls today

ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A

Quantity: 32,184 units

Distribution: Worldwide - Nationwide and the country of Canada.

Recall number Z-0109-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

UROLOGY MAJOR; Model/Item Number (Kit): WRNM058-10;

Quantity: 20

Distribution: US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.

Recall number Z-0103-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

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

Quantity: 58 systems

Distribution: Worldwide - US Nationwide and the countries of Australia, Canada, New Zealand.

Recall number Z-0118-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

CRANIOTOMY PACK; Model/Item Number (Kit): WRNM035-20;

Quantity: 10

Distribution: US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.

Recall number Z-0096-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M

Quantity: 1 implant

Distribution: US Nationwide distribution in the states of North Carolina, and California.

Recall number Z-0090-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

ADULT HEART TRAY SHANDS JACKS; Model/Item Number (Kit): SHND419-08;

Quantity: 59

Distribution: US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.

Recall number Z-0094-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007

Quantity: 409

Distribution: Worldwide - US Nationwide distribution.

Recall number Z-0071-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11;

Quantity: 6

Distribution: US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.

Recall number Z-0098-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060

Quantity: 1185

Distribution: Worldwide - US Nationwide distribution.

Recall number Z-0072-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Glypto Device, Glypto Cryo Machine;

Quantity: 219

Distribution: US Nationwide distribution.

Recall number Z-0080-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061

Quantity: 2205

Distribution: Worldwide - US Nationwide distribution.

Recall number Z-0073-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006

Quantity: 266

Distribution: Worldwide - US Nationwide distribution.

Recall number Z-0070-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

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, 81-133-MC; IFAK Bag, Advanced, Black - Stocked, 81-135-BL; IFAK Bag, Advanced, Multicam - Stocked, 81-135-MC; LEO Patrol Kit, 81-139; IFAK Refill, 81-301; IFAK Resupply, 81-303-01; IFAK Resupply - CS/30, 81-303-30; K9 Trauma Kit, 81-605; Medic Enhancement Set, 82-504-03; Medic Enhancement Resupply, 82-504-05; Emergency Trauma Kit, 82-520; First Responder - Intermediate, Coyote Brown, 83-303; First Responder, Intermediate, Black, 83-303-BL; DC-First Responder - Intermediate - Foliage Green, 83-303-FG; First Responder, Intermediate, Multicam, 83-303-MC; First Responder - Advanced- Coyote Brown, 83-305-CB; Combat Life Saver - Intermediate - Coyote Brown, 83-323-CB; Combat Life Saver - Intermediate - Multicam, 83-323-MC; Multi Mission, Advanced, Black - Stocked, 84-446-01-BL; Multi Mission, Advanced, Coyote Brown - Stocked, 84-446-01-CB; Multi Mission, Advanced, Multicam - Stocked, 84-446-01-MC; Direct Action Bag, Coyote Brown, Advanced, Stocked, 84-497-CB; DC-DIRECT ACTION BAG, FOLIAGE GREEN, ADVANCED, STOCKED, 84-497-FG; Direct Action Bag, Multicam, Advanced, Stocked, 84-497-MC; Bleeding Control Kit - Adv…

Quantity: 46,881

Distribution: Worldwide - US Nationwide distribution including in the states of FL, OK, CA, WA, GA, TX, PA, IL, MD, NC, OR, DE, NJ, MI, RI, AR, WI, AZ, CO, IN, MO, OH, MA, NY, VA, KY, UT, NM, SC, TN, LA, AL, MN, MT, AK, WV, KS, NE, WY, MS, HI, NH, IA, DC, CT and the countries of BRA, BEL, SGP, AUS.

Recall number Z-0081-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

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. The CNS-6200 Series Central Nurse Station will display and record physiological data from up to forty telemetry receiver/transmitters and generates an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmia is detected. Arrhythmia detection and alarm determination are functions of the telemetry receivers/transmitters or individual bedside monitor. Component: No

Quantity: 808

Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN. KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NL, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, QA, WA, WI, WV and WY.

Recall number Z-0089-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M

Quantity: 1 implant

Distribution: US Nationwide distribution in the states of North Carolina, and California.

Recall number Z-0091-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

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

Quantity: 835 units

Distribution: Worldwide distribution - US Nationwide and the country of Canada.

Recall number Z-0087-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

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.);

Quantity: 539

Distribution: Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CO, FL, GA, HI, IL, IN, KY, MA, MD, MN, NC, NY, OH, PA, TX, VA, WV and the countries of Australia, Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, Denmark, Ecuador, El Salvador, France, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lithuania, Macao, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Nicaragua, Norway, Palestine, Panama, Philippines, Poland, Portugal, Romania, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, Vietnam.

Recall number Z-0078-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin 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 and securely communicate with compatible digitally connected devices, including an integrated continuous glucose monitor (iCGM), interoperable Medtronic continuous glucose monitor (CGM), and interoperable automated glycemic controller (iAGC). The pump is intended to be used in conjunction with compatible, digitally connected medical devices for the purpose of drug delivery. The primary user interface and primary display for the MiniMed Flex pump is the MiniMed app, also the user interface for the compatible MiniMed iAGCs, which runs on a compatible iOS or Android device.

Quantity: 25

Distribution: U.S. Nationwide distribution in the states of AR, AZ, CO, FL, KS, KY, LA, MI, MN, NJ, NY, OH, PA, SD, TN, TX, and WV.

Recall number Z-0088-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

VERIFY Biological Steam Test Pack Model/Catalog Number: S3065

Quantity: 217

Distribution: Worldwide - US Nationwide distribution.

Recall number Z-0074-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007

Quantity: 10

Distribution: US Nationwide distribution in the state of NJ.

Recall number Z-0085-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

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.

Quantity: 1 vial

Distribution: Nationwide within the United States

Recall number D-0037-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Sterile Eye Drops 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 44256, UPC: 0 93351 03411 4; c) EQUALINE, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 46151 2; d) Colirio Ojo de Aguila, Distributed by Grandall Distributing Co., Inc., Glendale, CA 91204, UPC: 3 48201 01615 5; e) Clear Eyes Redness Relief, ¿ 2025 Dist. by Medtech Products Inc., Tarrytown, NY 10591, UPC 6 78112 25415 6; f) Equate", DISTRIBUTED BY WALMART INC., Bentonville, AR 72716, NDC 79903-012-01; g) Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 17741 0; h) Xpect Industrial Eye Relief, Distributed by: Cintas Corp., Mason, OH 45040, UPC: 130209.

Quantity: N/A

Distribution: US Nationwide

Recall number D-0008-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

SERMORELIN ACETATE 1 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland

Quantity: 15 mls - in patient specific syringe doses

Distribution: Nationwide within the U.S

Recall number D-0020-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

Quantity: 8 x 0.1 ml syringes

Distribution: Nationwide within the U.S

Recall number D-0018-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

Quantity: 57.0 mls - in patient specific syringe doses

Distribution: Nationwide within the U.S

Recall number D-0019-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25114 4; b) Good Sense Sterile Eye Drops, Distributed By: Geiss, Destin & Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, NDC 50804-121-01; c) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43746 7; d) QC-Quality Choice, Sterile Eye drops Irritation Relief, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-190-14; e) TopCare health TM, DISTRIBUTED BY: TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 03640 6.

Quantity: 182,016 cartons

Distribution: US Nationwide

Recall number D-0003-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-9.

Quantity: N/A

Distribution: US Nationwide.

Recall number D-0033-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

Quantity: 82.9 mls - in patient specific syringe dose

Distribution: Nationwide within the U.S

Recall number D-0026-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS CITY, KS 66106, UPC 0 70038 47008 3; b) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428, NDC 24385-006-05; d) Good Sense, Distributed By: Geiss, Destin& Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, NDC 50804-110-01; e) Medic'c Choice, Sterile 0.5 fl. oz. (15 mL), Manufactured by KC Pharmaceuticals, Inc., Pomona, CA 91768, NDC 55651-008-01; f) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; g) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14; h) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; I) Walgreens, DISTRIBUTED BY: WALGREEN CO. DEERFIELD, IL 60015, UPC 3 11917 06503 8; J) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7.

Quantity: 505,896 cartons

Distribution: US Nationwide

Recall number D-0002-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936;

Quantity: 5.6 mLs - in patient specific syringe doses

Distribution: Nationwide within the U.S

Recall number D-0017-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.