510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,460 records, page 130 of 1190
FDA device recalls, page 130 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0014-2025Class IICADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24Abbott MedicalFPA
Z-0013-2025Class IICADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24Abbott MedicalFPA
Z-0012-2025Class IICADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24Abbott MedicalFPA
Z-0011-2025Class IICADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24Abbott MedicalFPA
Z-0010-2025Class IICADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24Abbott MedicalFPA
Z-3308-2024Class IIDVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd.QYT
Z-3307-2024Class IIDVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd.QYT
Z-3306-2024Class IIDVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd.QYT
Z-2242-2024Class IIARTIS is a family of dedicated angiography systems developed for single and biplane...Siemens Healthineers AGOWB
Z-2241-2024Class IIARTIS is a family of dedicated angiography systems developed for single and biplane...Siemens Healthineers AGOWB
Z-2458-2024Class IIBD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533...Becton Dickinson Infusion Therapy Systems Inc.FOZ
Z-2240-2024Class IIARTIS is a family of dedicated angiography systems developed for single and biplane...Siemens Healthineers AGOWB
Z-3164-2024Class II1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6"...Unimax Medical Systems Inc.GCJ
Z-2583-2024Class IIHeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular...Abbott MedicalDSQ
Z-2687-2024Class IIMultiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm...PREAT CorporationNDP
Z-2503-2024Class IIBD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9CareFusion 303, IncBRY
Z-2502-2024Class IIBD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version 3.9.1.9CareFusion 303, IncBRY
Z-2501-2024Class IIBD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software version 3.9.1.9CareFusion 303, IncBRY
Z-2500-2024Class IIBD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P, REF: 169-96 containing software version 3.9.1.9CareFusion 303, IncBRY
Z-2499-2024Class IIBD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version 3.9.1.9CareFusion 303, IncBRY
Z-2498-2024Class IIBD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software version 3.9.1.9CareFusion 303, IncBRY
Z-2497-2024Class IIBD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software version 3.9.1.9CareFusion 303, IncBRY
Z-2496-2024Class IIBD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version 3.9.1.9CareFusion 303, IncBRY
Z-2495-2024Class IIBD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software version 3.9.1.9CareFusion 303, IncBRY
Z-2494-2024Class IIBD PYXIS MEDBANK TWR MN CR-2HH-6FM, REF: 169-89 containing software version 3.9.1.9CareFusion 303, IncBRY
Z-2493-2024Class IIBD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9CareFusion 303, IncBRY
Z-2492-2024Class IIBD PYXIS MEDBANK TWR MN CR-14HH-P, REF: 169-86 containing software version 3.9.1.9CareFusion 303, IncBRY
Z-2491-2024Class IIBD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software version 3.9.1.9CareFusion 303, IncBRY
Z-2490-2024Class IIBD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version 3.9.1.9CareFusion 303, IncBRY
Z-2489-2024Class IIBD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 containing software version 3.9.1.9CareFusion 303, IncBRY
Z-2488-2024Class IIBD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software version 3.9.1.9CareFusion 303, IncBRY
Z-2487-2024Class IIBD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9CareFusion 303, IncBRY
Z-2486-2024Class IIBD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9CareFusion 303, IncBRY
Z-2485-2024Class IIBD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9CareFusion 303, IncBRY
Z-2409-2024Class INIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital...Medtronic Xomed, Inc.GWF
Z-2446-2024Class IPuritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560...Medtronic, Inc.CBK
Z-2415-2024Class IIESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories...OLYMPUS Corporation of the AmericasGEI
Z-2533-2024Class IIVerigene Gram Positive Blood Culture (BC-GP) Nucleic Acid TestLuminex CorporationPAM
Z-2584-2024Class IICepheid, Sample Collection Device, Part: 900-0370CepheidJSM
Z-2418-2024Class IIArial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call...Securitas Healthcare LLCIQA
Z-2417-2024Class IIArial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated...Securitas Healthcare LLCIQA
Z-2456-2024Class IIBIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY...BioFire Diagnostics, LLCPEN
Z-2372-2024Class IIUNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip...Howmedica Osteonics CorpKWL
Z-2371-2024Class IIUNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip...Howmedica Osteonics CorpKWL
Z-2370-2024Class IIUNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip...Howmedica Osteonics CorpKWL
Z-1890-2025Class IIFoundationOne Companion Diagnostic (F1CDx)Foundation Medicine, Inc.PQP
Z-3072-2024Class IIANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377AMEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-3071-2024Class IIANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-3070-2024Class IIKIT PEDI CRANI LAMI, Pack Number DYNJ907372AMEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-3069-2024Class IICRANIOTOMY PACK, Pack Number DYNJ46552OMEDLINE INDUSTRIES, LP - NorthfieldOJH