511 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code MDB·September 12, 2023
BD BACTEC" MGIT" 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code MJA·May 20, 2025
BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JQP·September 12, 2024
BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code QEP·October 31, 2024
BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code MDB·October 31, 2024
BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code KZJ·April 7, 2026
Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog Number: 1023780 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A
FDA Recall
Open, Classified
·HF Acquisition Co LLC·Product code FRC·April 13, 2026
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
FDA Recall
Open, Classified
·Healthmark Industries Co., Inc.·Product code OCU·March 12, 2026
BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 and 232175
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
BD BBL Sensi Disc Ampicillin - 10 g, Catalog No. 230705 and 231264; 2 g, Catalog No. 231263. Used for semi-quantitative in vitro susceptibility testing.
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231250 and 231251
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231703 and 231704
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code KZB·July 9, 2024
BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code QEP·October 31, 2024
BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JQP·October 31, 2024
BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code MDB·October 31, 2024
BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code MAQ·October 31, 2024
BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676. 3. BACTEC 9240 System, Catalog Number: 445569. 4. BD BACTEC FX40 Instrument, Catalog Number: 44229609.
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code MDB·September 23, 2025
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code LIB·October 23, 2025
BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform. An in vitro diagnostic medical device intended to automate specimen processing according to user-defined procedures and protocols. Catalog (Ref) No. : 447213
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTC·March 22, 2023