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 59 of 1190
FDA device recalls, page 59 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0228-2026Class IILOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS...Synthes (USA) Products LLCJDS
Z-0374-2026Class ICODMAN Disposable Perforator 9mm. Cranial Perforator.Integra LifeSciences CorporationHBF
Z-0373-2026Class ICODMAN Disposable Perforator 11mm. Cranial Perforator.Integra LifeSciences CorporationHBF
Z-0563-2026Class IISAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 L; Prepared with Balanced...ASP Global, LLCGIO
Z-0562-2026Class IISAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 L; Prepared with Sodium...ASP Global, LLCGIO
Z-0561-2026Class IISAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 L; Prepared with Sodium...ASP Global, LLCGIO
Z-0560-2026Class IISAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 L; Prepared with Sodium...ASP Global, LLCGIO
Z-0559-2026Class IISAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 L; Untreated. Model 06 0199...ASP Global, LLCGIO
Z-0558-2026Class IISAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 L; Prepared with Balanced Heparin...ASP Global, LLCGIO
Z-0557-2026Class IISAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 L; Prepared with Balanced...ASP Global, LLCGIO
Z-0556-2026Class IISAFE-T-FILL MicroHematocrit Capillary Tubes, 50 L; Untreated, Blue Markings Model/Catalog...ASP Global, LLCGIO
Z-0555-2026Class IISAFE-T-FILL MicroHematocrit Capillary Tubes, 50 L; Plastic, Ammonium Heparinized, Red...ASP Global, LLCGIO
Z-0554-2026Class IISAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Clot Activator; Amber...ASP Global, LLCJKA
Z-0553-2026Class IISAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Sodium Fluoride...ASP Global, LLCJKA
Z-0552-2026Class IISAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Lithium Heparin...ASP Global, LLCJKA
Z-0551-2026Class IISAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Lithium Heparin...ASP Global, LLCJKA
Z-0550-2026Class IISAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Lithium Heparin and...ASP Global, LLCJKA
Z-0549-2026Class IIAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Lithium Heparin and...ASP Global, LLCJKA
Z-0548-2026Class IISAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Clot Activator...ASP Global, LLCJKA
Z-0547-2026Class IISAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Clot Activator...ASP Global, LLCJKA
Z-0546-2026Class IISAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Clot Activator and...ASP Global, LLCJKA
Z-0545-2026Class IISAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Clot Activator and...ASP Global, LLCJKA
Z-0544-2026Class IISAFE-T-FILL Micro Capillary Blood Collection, 125 L; Prepared with Lithium Heparin...ASP Global, LLCJKA
Z-0486-2026Class IICovidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX...Medtronic, Inc.GDW
Z-0485-2026Class IICovidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN...Medtronic, Inc.GDW
Z-0377-2026Class IIModel: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X...Philips North America LLCJAK
Z-0289-2026Class IIArtegraft Collagen Vascular Graft; REF: AG1015;LeMaitre Vascular Inc.LXA
Z-0376-2026Class IIModel: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;Philips North America LLCJAK
Z-0375-2026Class IIModel: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions...Philips North America LLCJAK
Z-0188-2026Class IBrand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog...Balt USA, LLCDQY
Z-0722-2026Class IICold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02DJO, LLCIME
Z-0490-2026Class IIHARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed...Stryker Sustainability SolutionsNLQ
Z-0312-2026Class IIBrand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog...Aesculap IncGCJ
Z-0311-2026Class IIBrand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number...Aesculap IncGCJ
Z-0310-2026Class IIBrand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number...Aesculap IncGCJ
Z-0309-2026Class IIBrand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog...Aesculap IncGCJ
Z-2513-2026Class IIiLet Bionic Pancreas, REF: BB1001Beta Bionics, Inc.QFG
Z-0432-2026Class IIBrand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar...Total Joint Orthopedics, Inc.KWY
Z-0212-2026Class IIBIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834...Zimmer GmbHMBI
Z-0240-2026Class IIBD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number...Becton Dickinson & CoJJQ
Z-0239-2026Class IIBD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated...Becton Dickinson & CoLON
Z-0238-2026Class IIBD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX...Becton Dickinson & CoOZN
Z-0237-2026Class IIBD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog...Becton Dickinson & CoMDB
Z-0236-2026Class IIBD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument...Becton Dickinson & CoMDB
Z-0235-2026Class IIBD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer...Becton Dickinson & CoJQP
Z-0366-2026Class IIAssay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1)...Siemens Healthcare Diagnostics Inc.CEW
Z-0541-2026Class IIDxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow...Siemens Healthcare Diagnostics Inc.OYE
Z-0478-2026Class IIVirata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The...Orthofix SRLNKB
Z-0216-2026Class IIDxI 9000 Access Immunoassay Analyzer, Part Number C11137Siemens Healthcare Diagnostics Inc.JLW
Z-0215-2026Class IIDxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number...Siemens Healthcare Diagnostics Inc.CGR