626 results
·
13ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
×
Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b) TRAY FOL LATX UM COUD 16FR MF, REF DYND150216CS; c) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S; d) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S; e) TRAY FOL LATX UM COUD 18FR MF, REF DYND150218CS; f) TRAY FOLEY LTX 18FR 10ML UM MF, REF DYND150218S; g) TRAY FOLEY LTX 18FR 10ML UM MF, REF DYND150218S; h) TRAY FOLEY SIL 16FR 10ML W/UM, REF DYND150816; i) TRAY FOL SIL UM COUD 16FR MF, REF DYND150816CS; j) TRAY FOL SIL 16FR 10ML W/UM MF, REF DYND150816S; k) TRAY FOL SIL UM COUD 18FR MF, REF DYND150818CS; l) TRAY FOL SIL 18FR 10ML W/UM MF, REF DYND150818S
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code PPB·September 4, 2024
Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850; b) MEDLINE SHOULDER SUSPENSION II-LF, Reorder Number DYNJSHOULDER2; c) MEDLINE TRAY BONE MARRO ASC LTX SAFE, Reorder Number P429589A; d) MEDLINE LUMBAR TRAY, Reorder Number SPEC0177; e) CENTURION MEDICAL PRODUCTS LUMBAR PUNCTURE KIT, Reorder Number PT235A
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OJH·December 7, 2022
MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Medline Kit/SKU DYNJ911589A; 3) CAROTID ENDARTECOMY, Medline Kit/SKU DYNJ36211D; 4) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973; 5) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973A; 6) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879; 7) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879C; 8) FEM POP CDS, Medline Kit/SKU CDS983670K; 9) LAP BASIN TRAY, Medline Kit/SKU DYNJ50908B; 10) OPEN HEART LTX CATHETERS KIT, Medline Kit/SKU DYNJ0049032A; 11) OPEN HEART PACK, Medline Kit/SKU DYNJ80549C; 12) OPEN HEART PACK, Medline Kit/SKU DYNJ80549D; 13) RR-ADULT ECMO PACK, Medline Kit/SKU DYNJ69742B; 14) TAVR, Medline Kit/SKU DYNJ906509C.
FDA Recall
Open, Classified
·Product code OES·May 4, 2026
TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.
FDA Recall
Open, Classified
·Trackx Technology Inc·Product code OWB·October 24, 2022
Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. Each TrackX Snap has a unique set of 2 or more reflective markers. By having unique configurations of reflective markers, it is possible to identify which TrackX Snap is in the field of view of the camera(s). As such, it is also possible to have multiple TrackX Snaps in the field at once and to have different TrackX Snaps for different surgical instruments. The device is considered to be a sterile accessory.
FDA Recall
Open, Classified
·Trackx Technology Inc·Product code OWB·September 3, 2024
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code ITX·November 10, 2022
FIRST RESPONSE 2 CT, SKU 902343
FDA Recall
Open, Classified
·Family Dollar Stores, Llc.·Product code LCX·October 4, 2023
PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS
FDA Recall
Open, Classified
·Universal Meditech Inc.·Product code LCX·May 22, 2023
Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue
FDA Recall
Open, Classified
·Scrip Inc·Product code ITX·August 18, 2021
EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU
FDA Recall
Open, Classified
·Red Medical Supplies·Product code ITX·August 11, 2021
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
FDA Recall
Open, Classified
·ImaCor Inc.·Product code ITX·September 16, 2024
Philips X5-1 Transducer.
FDA Recall
Open, Classified
·Philips Ultrasound, Inc·Product code ITX·May 28, 2025
Philips L12-4 Transducer.
FDA Recall
Open, Classified
·Philips Ultrasound, Inc·Product code ITX·May 28, 2025
Philips L9-3 Transducer.
FDA Recall
Open, Classified
·Philips Ultrasound, Inc·Product code ITX·May 28, 2025
Pregnancy Test
FDA Recall
Open, Classified
·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code LCX·November 3, 2025
PREGNANCY TEST 24CT
FDA Recall
Open, Classified
·GOLD STAR DISTRIBUTION INC·Product code LCX·December 26, 2025
SCNHD LA L7-4 HDI Transducer Probe
FDA Recall
Open, Classified
·Philips Ultrasound, Inc·Product code ITX·July 3, 2025
Philips Mini Multi TEE Ultrasound Transducer
FDA Recall
Open, Classified
·Philips Ultrasound, Inc·Product code ITX·September 5, 2025
Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180, GF-UE160-AL5.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code ITX·September 25, 2023
EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
FDA Recall
Open, Classified
·Red Medical Supplies·Product code ITX·August 11, 2021