103 results
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14ms
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Sources: EU EUDAMED, US FDA
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Recall
Open, Classified
·Exactech, Inc.·Product code HRY·August 30, 2021
EVOLUTION MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
FDA Recall
Open, Classified
·MicroPort Orthopedics Inc.·Product code HRY·May 3, 2024
EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base
FDA Recall
Open, Classified
·MicroPort Orthopedics Inc.·Product code HRY·October 28, 2022
EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
FDA Recall
Open, Classified
·MicroPort Orthopedics Inc.·Product code HRY·October 28, 2022
Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component Item Number: 154341
FDA Recall
Open, Classified
·Biomet, Inc.·Product code HRY·December 15, 2022
ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073
FDA Recall
Open, Classified
·Luminex Corporation·Product code OOI·February 20, 2019
ARIES SARS-CoV-2 Assay
FDA Recall
Open, Classified
·Luminex Corporation·Product code QJR·July 14, 2022
Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452
FDA Recall
Open, Classified
·Luminex Corporation·Product code OZZ·February 20, 2019
ARIES SARS-CoV-2 Assay, REF: 50-10047
FDA Recall
Open, Classified
·Luminex Corporation·Product code QJR·September 14, 2022
ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
FDA Recall
Open, Classified
·Luminex Corporation·Product code NJR·February 20, 2019
ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
FDA Recall
Open, Classified
·Luminex Corporation·Product code PGI·February 20, 2019
ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
FDA Recall
Open, Classified
·Luminex Corporation·Product code OZN·February 20, 2019
ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
FDA Recall
Open, Classified
·Luminex Corporation·Product code PGX·February 20, 2019
ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
FDA Recall
Open, Classified
·Luminex Corporation·Product code OZE·February 20, 2019
Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ
FDA Recall
Open, Classified
·Remel, Inc·Product code LRG·February 12, 2025
BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software version 3.9.1.9
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·June 24, 2024
BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·June 24, 2024
BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·June 24, 2024
BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC, Wired Scanner 1.7.3, REF: 107-256-01; CII Safe ES, Desktop PC, Wireless Scanner 1.7.3, REF: 107-257-01
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·May 2, 2024
BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES Tower), REF: 352; all with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2.5). Pyxis MedStation Enterprise Server (ES) System is an automated medication dispensing system supporting decentralized medication management in a pharmaceutical environment.
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·February 14, 2023