1,370 results · 16ms · Sources: EU EUDAMED, US FDA

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IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CFL·April 15, 2016

IGFBP-3 Immunoradiometric Assay (IRMA) Kit, Part Number: DSL-6600 usage: The DSL6600 IGFBP-3 immunoradiometric assay (IRMA) kit provides materials for the quantitative measurement of IGFBP-3 in serum. This assay is intended for in vitro diagnostic use.

FDA Recall
Terminated ·Beckman Coulter Inc.·Product code CFL·August 9, 2010

cobas e801 Immunoassay Analyzer

FDA Recall
Open, Classified ·Roche Diagnostics Operations, Inc.·Product code JJE·July 14, 2022

DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)

FDA Recall
Open, Classified ·ConvaTec, Inc·Product code NAD·August 9, 2021

- NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile) - NGF-60 60ml Nutrio GraviFeed Syringe (sterile) The Enteral Syringe consists of a calibrated hollow cylindrical body and movable plunger. At the tip of the barrel is an oral lock connector. Product is considered sterile.

FDA Recall
Terminated ·Medela Inc. EF Division·Product code FMF·February 13, 2015

Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.

FDA Recall
Open, Classified ·Immunotech A.S. Radiova 1 Prague·Product code CGF·June 12, 2025

Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.

FDA Recall
Open, Classified ·Beckman Coulter Inc.·Product code CGF·June 12, 2025

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. NON VASCULAR PACK, Medline SKU # DYNJ68037C; 2. VEIN, Medline SKU # DYNJ89845; 3. VEIN, Medline SKU # DYNJ89845A.

FDA Recall
Open, Classified ·Product code OFF·February 27, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CENTRAL LINE TRAY DYNJ41089 FISTULAGRAM PACK DYNJ62827A FISTULOGRAM PACK DYNJ47899A INVASIVE LINE INSERTION DYNJ44123B NON VASCULAR PACK DYNJ68037A VASCULAR ACCESS PACK-LF DYNJ0101291F

FDA Recall
Open, Classified ·Product code OFF·February 27, 2026

Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT DERM SURG PACK c. THROMBECTOMY PACK-LF d. AV FISTULA PACK e. AV SHUNT PACK-LF f. RR-VP SHUNT PACK-LF g. VEIN HARVESTING PACK-LF h. AV FISTULA PACK-LF i. PK, GEN-BARIATRIC j. VEIN PACK k. VENOUS ACCESS PACK-LF l. VENOUS ACCESS PACK m. VASCULAR ACCESS PACK n. ARTERIOGRAM PACK o. AV FISTULA/GRAFT INSER PK p. VEIN ABLATION PACK q. PORT PACK r. MINOR VASCULAR s. FISTULA PACK t. AV FISTULA-LF u. AV FISTULA v. PORT VENOUS ACCESS w. AV FISTULA

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFF·November 17, 2022

Medline procedural kits labeled as: 1) CAROTID ENDARTERECTOMY PK, Pack Number DYNJ85516; 2) PICC INSERTION TRAY W/O CATH, Pack Number PICCNC0004; 3) VASCATH INSERTION PACK, Pack Number, CVI4825

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFF·April 8, 2024

Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids, nutrients, or blood products over a long period of time, usually several weeks or more. A catheter is often inserted in the arm or chest through the skin into a large vein. The catheter is threaded through this vein until it reaches a large vein near the heart.

FDA Recall
Terminated ·Medline Industries Inc·Product code OFF·August 3, 2015

Centurion PICC : CVI2650 ANGIO TRAY CVI3610 CENTRAL LINE INSERTION BUNDLE CVI4025 PICC INSERTION BUNDLE (P/S) CVI4190 CENTRAL LINE INSERTION BUNDLE CVI4190 CENTRAL LINE INSERTION BUNDLE CVI4330 PICC INSERTION TRAY CVI4340 MIDLINE INSERTION TRAY CVI4485 MOUNT SINAI CVP INSERTION KIT CVI515 VENOUS ACCESS KIT CVI650 INSERTION TRAY

FDA Recall
Terminated ·Centurion Medical Products Corporation·Product code OFF·December 11, 2019

CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFF·November 1, 2023

Medline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO, Model Number: ACC011142; 2) CENTRAL AND ARTERIAL LINE TOTE, Model Number: DYNJ8407

FDA Recall
Open, Classified ·Product code OFF·May 6, 2026

Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB SHUNT, Model NumberDYNJ905860A, Lot codes: 22OBG246, 21LBU048, 21GBI196, 21KBK242, 21EBH567 Model/Catalog Number: a. Model Number DYNJ36725B, b. Model Number DYNJ905860A

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP SPT·Product code OFF·June 6, 2022

Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52; b) Adult Central Line Insertion Supply Kit, kit number UICL44N; c) Pediatric Central Line Insertion, kit number UIPL77K

FDA Recall
Open, Classified ·American Contract Systems, Inc.·Product code OFF·November 29, 2023

Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KIT

FDA Recall
Open, Classified ·American Contract Systems Inc.·Product code OFF·September 4, 2025

Estrone RIA, REF: DSL8700

FDA Recall
Open, Classified ·Immunotech A.S. Radiova 1 Prague·Product code CGF·December 15, 2025

Estrone Radioimmunoassay (RIA) Kit, DSL-8700. Intended for in vitro diagnostic use.

FDA Recall
Terminated ·Beckman Coulter Inc.·Product code CGF·April 22, 2010