510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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

59,476 records, page 223 of 1190
FDA device recalls, page 223 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0423-2023Class IIOmnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM...Insulet CorporationQFG
Z-1349-2023Class IIAbbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.Abbott Molecular, Inc.OOI
Z-0479-2023Class IIPower-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)Stryker MedicalFPO
Z-0738-2023Class IIX-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with...NuVasive IncMQP
Z-0759-2023Class IIVivid q N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis...GE HealthcareITX
Z-0758-2023Class IIVivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis...GE HealthcareITX
Z-0757-2023Class IIVivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics...GE HealthcareITX
Z-0756-2023Class IIVivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525...GE HealthcareITX
Z-0755-2023Class IIVivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis...GE HealthcareIYN
Z-0754-2023Class IIVivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis...GE HealthcareIYN
Z-0753-2023Class IIVivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics...GE HealthcareIYN
Z-0752-2023Class IIVivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics...GE HealthcareIYN
Z-0472-2023Class IIARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1...Siemens Medical Solutions USA, Inc.IYE
Z-0876-2023Class IIPpm Lombard Products T Phosphate Buffersterile 20X9ml, Catalog T8035bioMerieux, Inc.JSO
Z-0875-2023Class IIPpm Lombard Products Ir&db - Tsa (32Ml) 10Plt, Catalog M1205-IrbioMerieux, Inc.JSO
Z-0874-2023Class IIPpm Lombard Products R2a Medium 10Plt, Catalog M1065bioMerieux, Inc.JSO
Z-0873-2023Class IIPpm Lombard Products Tsa 10Plt, Catalog M1040bioMerieux, Inc.JSO
Z-0872-2023Class IIPpm Lombard Products Ct&ti-Tsa + L & P80 10Plt, Catalog C6045-TibioMerieux, Inc.JSO
Z-0871-2023Class IIPpm Lombard Products Ct&ir&db-Tsa + L & P80 10Plt, Catalog C6045-IrbioMerieux, Inc.JSO
Z-0870-2023Class IIPpm Industry Combourg Bacara 20Plates 90Mm, Catalog Aeb520100bioMerieux, Inc.JSO
Z-0869-2023Class IIDcount Systems Reagents Chemchrome V14 (6X1.8ml), Catalog 306-R1026-01bioMerieux, Inc.JTO
Z-0868-2023Class IIVidas Clinical Vidas Brahms Procalcitonin 60T, Catalog 30450-01bioMerieux, Inc.NTM
Z-0867-2023Class IIVidas Clinical Vidas Estradiol II 60 Tests, Catalog 30431-01bioMerieux, Inc.CHP
Z-0866-2023Class IIVidas Clinical Vidas Progesterone 60 Tests, Catalog 30409-01bioMerieux, Inc.JLS
Z-0865-2023Class IIVidas Clinical Vidas Lh 60 Tests, Catalog 30406-01bioMerieux, Inc.CEP
Z-0864-2023Class IIVidas Clinical Vidas Hcg 60 Tests, Catalog 30405-01bioMerieux, Inc.LYR
Z-0863-2023Class IIEtest Clinical Colistin Co 256 US B100, Catalog 537348bioMerieux, Inc.JTO
Z-0862-2023Class IIAstute Reagent Nephrocheck Liquid Controls Kit US, Catalog 500013bioMerieux, Inc.JTO
Z-0861-2023Class IIVitek 2 Reagent Ast-Xn15 Test Kit 20 Cards, Catalog 423829bioMerieux, Inc.LON
Z-0860-2023Class IIEtest Clinical Etest Vancomycin Va M100 US, Catalog 423788bioMerieux, Inc.JWY
Z-0859-2023Class IIEtest Clinical Etest Meropenem Mp M100 US, Catalog 423786bioMerieux, Inc.JWY
Z-0858-2023Class IIPpm Lombard Products Tsa 3P W Neutralizers 100 Plt, Catalog 423723bioMerieux, Inc.JSO
Z-0857-2023Class IIVitek 2 Reagent Ast-Xn09 Test Kit 20 Cards, Catalog 423425bioMerieux, Inc.LTW
Z-0856-2023Class IIVitek 2 Reagent Ast-N801 Test Kit 20 Cards, Catalog 423416bioMerieux, Inc.LTW
Z-0855-2023Class IIGENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105bioMerieux, Inc.LSM
Z-0854-2023Class IIVitek 2 Reagent Ast-Gn99 Test Kit 20 Cards, Catalog 423102bioMerieux, Inc.LON
Z-0853-2023Class IIVitek 2 Reagent Ast-Gn95 Test Kit 20 Cards, Catalog 421982bioMerieux, Inc.LON
Z-0852-2023Class IIEtest Clinical Etest Meropenem/vaborbactam Mev US S30, Catalog 421560bioMerieux, Inc.JWY
Z-0851-2023Class IIEtest Clinical Eravacycline Erv US S30, Catalog 421553bioMerieux, Inc.JWY
Z-0850-2023Class IIVitek 2 Reagent Ast-Gp78 Test Kit 20 Cards, Catalog 421051bioMerieux, Inc.LON
Z-0849-2023Class IIEtest Clinical Imipenem Relebactam Ipr US S30, Catalog 420927bioMerieux, Inc.JWY
Z-0848-2023Class IIVitek 2 Reagent Ast-St02 Test Kit 20 Cards, Catalog 420915bioMerieux, Inc.LON
Z-0847-2023Class IIPpm Clinical Chromid Strepto B US 20 Plt, Catalog 419751bioMerieux, Inc.PQZ
Z-0846-2023Class IIEtest Clinical Ceftazidim/avibactam US S30, Catalog 419046bioMerieux, Inc.JWY
Z-0845-2023Class IIPpm Lombard Products Tsa 3P W Neutralizers 100 Plt, Catalog 419014bioMerieux, Inc.JSO
Z-0844-2023Class IIPpm Lombard Products Irr Count-Tact 3P Agar 100 Plt, Catalog 418049bioMerieux, Inc.JSO
Z-0843-2023Class IIVitek 2 Reagent Ast-Gp75 Test Kit 20 Cards, Catalog 415670bioMerieux, Inc.LON
Z-0842-2023Class IIPpm Clinical Chromid Mrsa S Aureus 20Plt US, Catalog 414524bioMerieux, Inc.JSO
Z-0841-2023Class IIEtest Clinical Ceftolozane/tazo c/t US S30, Catalog 414445bioMerieux, Inc.JWY
Z-0840-2023Class IIGene-Up Reagent Gene-Up Lysis Kit, Catalog 414057bioMerieux, Inc.NVQ