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 184 of 1190
FDA device recalls, page 184 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2634-2023Class IIVarious Medical Products stored on pallets, including but not limited to bandages...Inmar Supply Chain Solutions, LLCN/A
Z-2625-2023Class IIPhilips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R...Remote Diagnostic Technologies Ltd.MHX
Z-0072-2024Class IILFS Flat screen support arm systems without surgical lamp for models Aurora series...DKK Dai-Ichi Shomei Co., Ltd.FSY
Z-0071-2024Class IILFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series...DKK Dai-Ichi Shomei Co., Ltd.FSY
Z-2645-2023Class IICinchlock SS Knotless Anchor Inserter, Part Number CAT02462Stryker Corp.MBI
Z-2619-2023Class IIMINISCAV (tm) Vacuum PumpR A Medical ServicesBTA
Z-0103-2024Class IIEMPOWR Acetabular System, Liner, 10 Hooded, HXe+, 40H, REF: 942-01-40HEncore Medical, LPLPH
Z-0102-2024Class IIEMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705Encore Medical, LPJWH
Z-0098-2024Class IIREVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF...Encore Medical, LPPHX
Z-0205-2024Class IISmiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.Abbott MedicalJOH
Z-2665-2023Class IItherascreen KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx...QiagenOWD
Z-2651-2023Class IIPuritan Bennett Cuff Pressure Manager, REF: 180-03Medtronic, Inc.BSK
Z-2653-2023Class IIApellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or...ApellisFMI
Z-2640-2023Class II3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify...3M CompanyFRC
Z-2639-2023Class II3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify...3M CompanyFRC
Z-2638-2023Class II3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and...3M CompanyFRC
Z-2637-2023Class II3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor...3M CompanyFRC
Z-2632-2023Class IIPalindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cmMedtronic, Inc.MSD
Z-0183-2024Class IIOpmi Lumera 300, Ref 6137Carl Zeiss Suzhou Co., Ltd.FSO
Z-0125-2024Class IIGladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651...North Coast Medical IncILH
Z-0099-2024Class IIConstellation Vision System, REF: 8065751150Alcon LaboratoriesHQC
Z-2646-2023Class IIBD Pyxis MedBank MedPass Software, REF: 139088-01CareFusion 303, IncBRY
Z-2608-2023Class IIPatient Information Center iX with Software Version Number 4.x in the...Philips North America LLCMHX
Z-0155-2024Class IISOZO Bilateral Arm L-Dex SoftwareImpedimed, Inc.OBH
Z-2633-2023Class IIexoplan version 3.1 Rijeka Software -A medical software, intended to support the...Exocad GmbHLLZ
Z-0092-2024Class IIPresource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile.Medtronic, Inc.OIP
Z-0081-2024Class IIMedfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion...Abbott MedicalFRN
Z-0080-2024Class IIMedfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pumpAbbott MedicalFRN
Z-0079-2024Class IIMedfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50...Abbott MedicalFRN
Z-0078-2024Class IIMedfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d)...Abbott MedicalFRN
Z-0077-2024Class IIMedfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6Abbott MedicalFRN
Z-0076-2024Class IIMedfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6Abbott MedicalFRN
Z-0091-2024Class IIProcedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource...Medtronic, Inc.OJH
Z-0090-2024Class IIProcedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B...Medtronic, Inc.OHM
Z-0089-2024Class IIProcedure packs: (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile; (2)...Medtronic, Inc.OJG
Z-0088-2024Class IIProcedure packs: (1) Presource Portacath Pack, Cat. SANV1PIFSB, Medstar Franklin Square...Medtronic, Inc.OKE
Z-0087-2024Class IIProcedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set...Medtronic, Inc.LRO
Z-0086-2024Class IIProcedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit...Medtronic, Inc.FDE
Z-0085-2024Class IIProcedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE...Medtronic, Inc.OGR
Z-2615-2023Class IIGallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF...Abbott MedicalNIK
Z-2614-2023Class IIGallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR...Abbott MedicalLWS
Z-0084-2024Class IIProcedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr...Medtronic, Inc.OEZ
Z-0083-2024Class IIProcedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center...Medtronic, Inc.OFQ
Z-2587-2023Class IIPhilips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and...Philips Medical Systems Nederland B.V.OWB
Z-2531-2023Class IIremel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci...Remel IncJSD
Z-2576-2023Class IIIKWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testingMicrobiologics, Inc.JTR
Z-1968-2025Class IIBrand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog...Turncare, IncFNM
Z-0122-2024Class IIFunctional MR V1.0Olea MedicalLLZ
Z-0004-2024Class IArrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded...Arrow International LLC (subsidiary of Teleflex Incorporated)LJS
Z-0003-2024Class IArrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ