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 46 of 1190
FDA device recalls, page 46 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1028-2026Class IIBD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02...CareFusion 303, IncBRY
Z-0986-2026Class IILYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number...Microbiologics, Inc.JTR
Z-0985-2026Class IIKWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog...Microbiologics, Inc.JTR
Z-0984-2026Class IIKWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog...Microbiologics, Inc.JTR
Z-0983-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade...Zimmer GmbHHSB
Z-0982-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade...Zimmer GmbHHSB
Z-0981-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade...Zimmer GmbHHSB
Z-0980-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade...Zimmer GmbHHSB
Z-0979-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade...Zimmer GmbHHSB
Z-0978-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade...Zimmer GmbHHSB
Z-0977-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade...Zimmer GmbHHSB
Z-0976-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade...Zimmer GmbHHSB
Z-0975-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade...Zimmer GmbHHSB
Z-0974-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade...Zimmer GmbHHSB
Z-0973-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade...Zimmer GmbHHSB
Z-0972-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade...Zimmer GmbHHSB
Z-0971-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade...Zimmer GmbHHSB
Z-0970-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade...Zimmer GmbHHSB
Z-0969-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade...Zimmer GmbHHSB
Z-0968-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade...Zimmer GmbHHSB
Z-0967-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade...Zimmer GmbHHSB
Z-1061-2026Class IIBD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF...Hangzhou Bever Medical Devices Co., Ltd.GBM
Z-1110-2026Class IIBrand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0...RaySearch Laboratories AB (publ)MUJ
Z-1109-2026Class IIBrand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number...RaySearch Laboratories AB (publ)MUJ
Z-1108-2026Class IIBrand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0...RaySearch Laboratories AB (publ)MUJ
Z-1107-2026Class IIBrand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number...RaySearch Laboratories AB (publ)MUJ
Z-1121-2026Class IISIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2Baxter Healthcare CorporationFRN
Z-1106-2026Class IIBrand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0...RaySearch Laboratories AB (publ)MUJ
Z-1105-2026Class IIBrand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number...RaySearch Laboratories AB (publ)MUJ
Z-1104-2026Class IIRayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0...RaySearch Laboratories AB (publ)MUJ
Z-1103-2026Class IIRayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software...RaySearch Laboratories AB (publ)MUJ
Z-1102-2026Class IIRayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan...RaySearch Laboratories AB (publ)MUJ
Z-1493-2026Class IIBrand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound...Advanced Bionics LLCMCM
Z-1016-2026Class IMEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LOMEDLINE INDUSTRIES, LP - NorthfieldLLI
Z-1015-2026Class IMEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003LMEDLINE INDUSTRIES, LP - NorthfieldLLI
Z-1014-2026Class IMEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELOMEDLINE INDUSTRIES, LP - NorthfieldLLI
Z-1013-2026Class IMEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) Full...MEDLINE INDUSTRIES, LP - NorthfieldLLI
Z-1012-2026Class IMEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002LMEDLINE INDUSTRIES, LP - NorthfieldLLI
Z-1011-2026Class IMEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E; 2) Semi...MEDLINE INDUSTRIES, LP - NorthfieldLLI
Z-1060-2026Class IIMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-1059-2026Class IIMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets...MEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-1058-2026Class IIMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets...MEDLINE INDUSTRIES, LP - NorthfieldNSB
Z-1057-2026Class IIMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets...MEDLINE INDUSTRIES, LP - NorthfieldOJU
Z-1056-2026Class IIMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets...MEDLINE INDUSTRIES, LP - NorthfieldLRS
Z-1055-2026Class IIMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1054-2026Class IIMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets...MEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-1053-2026Class IIMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets...MEDLINE INDUSTRIES, LP - NorthfieldRDE
Z-1052-2026Class IIMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-1051-2026Class IIMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets...MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-1050-2026Class IIMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets...MEDLINE INDUSTRIES, LP - NorthfieldOEZ