FDA Device Recalls

Class IIOngoing

MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097; 2) CRANI, Medline Kit Number/SKU DYNJ908097A; 3) CRANI, Medline Kit Number/SKU DYNJ908097B; 4) CRANI, Medline Kit Number/SKU DYNJ908097C; 5) CRANI, Medline Kit Number/SKU DYNJ908097D; 6) DR TUCKER ANT TOTAL HIP, Medline Kit Number/SKU DYNJ912029; 7) JEWISH CRANI PACK, Medline Kit Number/SKU DYNJ55637B; 8) L SCOPE PACK, Medline Kit Number/SKU DYNJ43930A; 9) LAMI PACK, Medline Kit Number/SKU DYNJ67767; 10) LAVH NEW BRAUNFELS, Medline Kit Number/SKU DYNJ61136F; 11) SOI KNEE ARTHROSCOPY, Medline Kit Number/SKU DYNJV0172Q; 12) T AND A PACK, Medline Kit Number/SKU DYNJ86229.

Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

May 4, 2026 · DeviceView details →

MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND10407

MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of products)

MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP SHUNT CDS, Medline Kit Number/SKU CDS983800J; 3) VP SHUNT CDS, Medline Kit Number/SKU CDS983800K.

MEDLINE Medical Procedure Kits labeled as: DR FERNANDEZ, Medline kit number/SKU DYNJ68808

MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Number/SKU DYNJ65199A

MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR14C

MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TRMC- PERI GYN PACK, RICH MINOR LITHOTOMY, etc. (see recall documents for a full list of products)

MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc. (see the recall documents for the full list of products)

Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840

Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830

CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930

Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500

DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.

CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040

Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940

Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models

Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX