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 90 of 1190
FDA device recalls, page 90 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1482-2025Class IIHemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208SStryker Corp.NHB
Z-1481-2025Class IINasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and...Stryker Corp.NHB
Z-1480-2025Class IINasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and...Stryker Corp.NHB
Z-1479-2025Class IINasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and...Stryker Corp.NHB
Z-1478-2025Class IINasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and...Stryker Corp.NHB
Z-1477-2025Class IIHemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and...Stryker Corp.NHB
Z-1476-2025Class IINasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITLStryker Corp.NHB
Z-1475-2025Class IIOtopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte...Stryker Corp.NHB
Z-1474-2025Class IINasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte...Stryker Corp.NHB
Z-1473-2025Class IINasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte...Stryker Corp.NHB
Z-1472-2025Class IIOtopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte...Stryker Corp.NHB
Z-1471-2025Class IINasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and...Stryker Corp.NHB
Z-1470-2025Class IINasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and...Stryker Corp.NHB
Z-1469-2025Class IIOtopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and...Stryker Corp.NHB
Z-1468-2025Class IIProgressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other...Baxter Healthcare CorporationIOQ
Z-1422-2025Class IIBaxter TruSystem 7500, Product Code 4091000Baxter Healthcare CorporationGDC
Z-1421-2025Class IIBaxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886Baxter Healthcare CorporationGDC
Z-1420-2025Class IIBaxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088Baxter Healthcare CorporationKXJ
Z-1419-2025Class IIBaxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087Baxter Healthcare CorporationJEA
Z-1418-2025Class IIBaxter TruSystem 7500 Hybrid (SC), Product Code 1854086Baxter Healthcare CorporationJEA
Z-1417-2025Class IIBaxter TruSystem 7500 Hybrid (FC), Product Code 1854085Baxter Healthcare CorporationJEA
Z-1416-2025Class IIBaxter TruSystem 7500 Hybrid (MC), Product Code 1773204Baxter Healthcare CorporationKXJ
Z-1415-2025Class IIBaxter Floor mounting column TS 7500 U, Product Code 1730732Baxter Healthcare CorporationKXJ
Z-1414-2025Class IIBaxter Stationary column TruSystem 7500 U, Product Code 1730731Baxter Healthcare CorporationKXJ
Z-1413-2025Class IIBaxter Mobile column TruSystem 7500 U, Product Code 1730720Baxter Healthcare CorporationKXJ
Z-1412-2025Class IIBaxter Mobile column TruSystem 7500, Product Code 1717023Baxter Healthcare CorporationJEA
Z-1411-2025Class IIBaxter Floor mounting column TruSystem 7500, Product Code 1717021Baxter Healthcare CorporationJEA
Z-1410-2025Class IIBaxter Stationary column TruSystem 7500, Product Code 1717020Baxter Healthcare CorporationJEA
Z-1409-2025Class IIBaxter Operating table column TS7500 MOBIUS, Product Code 1704695Baxter Healthcare CorporationGDC
Z-1505-2025Class IMedline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1508-2025Class IIBoppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007Pyrames IncDXN
Z-1467-2025Class IIBrand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian...Checkpoint Surgical IncETN
Z-1466-2025Class IIBrand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian...Checkpoint Surgical IncETN
Z-1315-2025Class IICOR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.DePuy Mitek, Inc.LXH
Z-1314-2025Class IICOR Disposable Kit, 8 mm. Cartilage Transplant System.DePuy Mitek, Inc.LXH
Z-1459-2025Class IMedline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1458-2025Class IMedline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as...MEDLINE INDUSTRIES, LP - NorthfieldKDD
Z-1457-2025Class IMedline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-1456-2025Class IMedline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-1532-2025Class IIIVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per...Omnicell, Inc.LHI
Z-1509-2025Class IIBD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta Plus 1 and...BD Switzerland SARLFMG
Z-1371-2025Class IIHelix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet)...Microbiologics, Inc.OHQ
Z-1454-2025Class IIHelix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial...Microbiologics, Inc.OHQ
Z-1432-2025Class IIOrthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile...Orthofix SRLMAX
Z-1878-2025Class IILazervida 10W diode laser cutter and engraver with Lazervida shield.Flux Technology Inc.RHK
Z-1531-2025Class IIWayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number...MEDLINE INDUSTRIES, LP - NorthfieldNAD
Z-1530-2025Class IIWayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3...MEDLINE INDUSTRIES, LP - NorthfieldNAC
Z-1487-2025Class IIGE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1)...GE HealthcareLLZ
Z-1486-2025Class IIGE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2)...GE HealthcareLLZ
Z-1485-2025Class IIGE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2)...GE HealthcareLLZ