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 57 of 1190
FDA device recalls, page 57 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0480-2026Class IIGM85 Digital Mobile X-ray imaging System; Model Number: GM85;Samsung HME America, Inc.IZL
Z-0538-2026Class IIIOC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed...Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLCJJY
Z-0493-2026Class IIFood Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number...Siemens Healthcare Diagnostics Inc.DHB
Z-0492-2026Class II3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor...Siemens Healthcare Diagnostics Inc.DHB
Z-0491-2026Class IIIMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog...Siemens Healthcare Diagnostics Inc.DHB
Z-0498-2026Class IIApplied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 90 Nasal Feeding Tube with...Applied Medical Technology IncKNT
Z-0497-2026Class IIApplied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 55 Nasal Feeding Tube with...Applied Medical Technology IncKNT
Z-0496-2026Class IIApplied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 90 Nasal Feeding Tube with...Applied Medical Technology IncKNT
Z-0495-2026Class IIApplied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 55 Nasal Feeding Tube with...Applied Medical Technology IncKNT
Z-0494-2026Class IIApplied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with...Applied Medical Technology IncKNT
Z-0459-2026Class IILiberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400Abbott MedicalMHY
Z-0458-2026Class IIEterna SCS IPG (Implantable Pulse Generator), Model Number 32400Abbott MedicalLGW
Z-0483-2026Class IIBrand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name...OLYMPUS Corporation of the AmericasFDI
Z-0482-2026Class IIBrand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use...OLYMPUS Corporation of the AmericasFDI
Z-0427-2026Class ITandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated...Tandem Diabetes Care, Inc.QFG
Z-0510-2026Class IIMedline Sterile Basic Eye Pack 16: 1) Ref: Dynj37743d; 2) Ref: Dynj37743f.MEDLINE INDUSTRIES, LP - NorthfieldOJK
Z-0509-2026Class IIMC3 VitalFlow Console, REF 58100; Blood pump of ecmoMedtronic Perfusion SystemsQNR
Z-0420-2026Class IITruDi Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number...Integra LifeSciences CorporationPGW
Z-0434-2026Class ICEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM...Cerenovus, Inc.HCG
Z-0719-2026Class IIPhilips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;Philips Medical Systems Nederland B.V.OWB
Z-0154-2026Class IIV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer...Abbott MedicalFMG
Z-0431-2026Class IMAGNETOM Cima.X Upgrade. Model Number: 11689304.Siemens Medical Solutions USA, Inc.LNH
Z-0477-2026Class IIMedline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated, Compatible with FT10...MEDLINE INDUSTRIES, LP - NorthfieldNUJ
Z-0476-2026Class IIMedline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated, Compatible w/FT10 37 cm...MEDLINE INDUSTRIES, LP - NorthfieldNUJ
Z-0475-2026Class IIMedline Renewal LigaSure Maryland Jaw Sealer/Divider Nano Coated, Compatible with FT10...MEDLINE INDUSTRIES, LP - NorthfieldNUJ
Z-0474-2026Class IIMedline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10...MEDLINE INDUSTRIES, LP - NorthfieldNUJ
Z-0473-2026Class IIMedline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10...MEDLINE INDUSTRIES, LP - NorthfieldNUJ
Z-0472-2026Class IIMedline RenewalLigasure Blunt Tip Sealer/Divider, NanoCoated Compatible with FT10...MEDLINE INDUSTRIES, LP - NorthfieldNUJ
Z-0471-2026Class IIMedline Renewal LigaSure Blunt Tip Sealer/Divider, Compatible with FT10 Generator, 5 mm x...MEDLINE INDUSTRIES, LP - NorthfieldNUJ
Z-0470-2026Class IIMedline Renewal LigaSure Small Jaw Instrument (Purple/White), Compatible with...MEDLINE INDUSTRIES, LP - NorthfieldNUJ
Z-0469-2026Class IIMedline Renewal Ligasure Impact Sealer/Divider NanoCoated, Compatible with FT10 Generator...MEDLINE INDUSTRIES, LP - NorthfieldNUJ
Z-0468-2026Class IIMedline Renewal LigaSure Impact Curved Large Jaw Sealer/Divider, Compatible with FT10...MEDLINE INDUSTRIES, LP - NorthfieldNUJ
Z-0467-2026Class IIMedline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW...MEDLINE INDUSTRIES, LP - NorthfieldNUJ
Z-0534-2026Class IIBrand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant...Quest International, Inc.LJB
Z-0466-2026Class IIRadiography 7300 C; Model Number: 712037;Philips Medical Systems DMC GmbHKPR
Z-0465-2026Class IIDigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1)...Philips Medical Systems DMC GmbHMQB
Z-0464-2026Class IIDigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2)...Philips Medical Systems DMC GmbHKPR
Z-0463-2026Class IIPrecision CRF; Model Number: 706400;Philips Medical Systems DMC GmbHJAA
Z-0462-2026Class IICombiDiagnost R90; Model Number: 709031;Philips Medical Systems DMC GmbHJAA
Z-0461-2026Class IIProxiDiagnost N90; Model Number: 706110;Philips Medical Systems DMC GmbHJAA
Z-0415-2026Class IIThermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control...Microgenics CorporationJJY
Z-0429-2026Class IIBeckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry...Siemens Healthcare Diagnostics Inc.JJE
Z-0428-2026Class IIBeckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry...Siemens Healthcare Diagnostics Inc.JJE
Z-0317-2026Class IIMagseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description...Endomagnetics LtdNEU
Z-0316-2026Class IIMagseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The...Endomagnetics LtdNEU
Z-0069-2026Class IAutomated Impella Controller (AIC), used for left heart support blood pump, labeled as...Abiomed, Inc.OZD
Z-0888-2026Class IIMaterial Processing Laser ProductsShenzhen Atomstack TechnologiesRFE
Z-0530-2026Class IIMEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-0529-2026Class IIMEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) MINOR...MEDLINE INDUSTRIES, LP - NorthfieldOJK
Z-0528-2026Class IIMEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004FMEDLINE INDUSTRIES, LP - NorthfieldOKV