411 results
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15ms
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Sources: EU EUDAMED, US FDA
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEQ·August 23, 2024
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
FDA Recall
Open, Classified
·Canadian Hospital Specialties Ltd.·Product code GCJ·June 11, 2024
microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.
FDA Recall
Open, Classified
·FHC, Inc.·Product code HAW·October 4, 2024
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA - Liatest D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R, STA Compact and STA Satellite analyzers by professional laboratory personnel. The STA - Liatest D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No
FDA Recall
Open, Classified
·Diagnostica Stago, Inc.·Product code DAP·February 5, 2026
Carina Sub-Acute Care Ventilator
FDA Recall
Open, Classified
·Draeger Medical, Inc.·Product code CBK·July 12, 2023
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable
FDA Recall
Open, Classified
·Draeger, Inc.·Product code OFP·March 12, 2025
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Number: MP17103 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only
FDA Recall
Open, Classified
·Draeger, Inc.·Product code OFP·March 12, 2025
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable
FDA Recall
Open, Classified
·Draeger, Inc.·Product code OFP·March 12, 2025
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable
FDA Recall
Open, Classified
·Draeger, Inc.·Product code OFP·March 12, 2025
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only
FDA Recall
Open, Classified
·Draeger, Inc.·Product code OFP·March 12, 2025
Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in human serum or plasma using the ADVIA Centaur XP/XPT System and ADVIA Centaur CP Systems, SMN:10492493
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc·Product code LIP·April 21, 2021
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code CFP·November 21, 2023
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
FDA Recall
Open, Classified
·DRG International, Inc.·Product code CFP·October 7, 2024
PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL
FDA Recall
Open, Classified
·Pentax of America Inc·Product code PEA·January 29, 2025
PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c
FDA Recall
Open, Classified
·Pentax of America Inc·Product code PEA·January 29, 2025
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c
FDA Recall
Open, Classified
·Pentax of America Inc·Product code PEA·January 29, 2025
Pentax Medical Video Processor; Model Number: EPK-i8020c;
FDA Recall
Open, Classified
·Pentax of America Inc·Product code PEA·July 16, 2025
Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Instrument Channels and a Water Jet Channel Models: EG-3890TK
FDA Recall
Open, Classified
·Pentax of America Inc·Product code FDF·July 14, 2021
Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels and a Water Jet Channel Model: EC-3890TLK
FDA Recall
Open, Classified
·Pentax of America Inc·Product code FDF·July 14, 2021
BF-MP160F: EVIS EXERA Bronchofibervideoscope
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code EOQ·March 8, 2022