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 187 of 1190
FDA device recalls, page 187 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2498-2023Class IIOlympus Bronchovideoscope, Models BF-XT190.OLYMPUS Corporation of the AmericasEOQ
Z-2497-2023Class IIOlympus Bronchovideoscope, Models BF-MP190F.OLYMPUS Corporation of the AmericasEOQ
Z-2496-2023Class IIOlympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190.OLYMPUS Corporation of the AmericasEOQ
Z-2495-2023Class IIOlympus Airway Mobilescope, Models MAF-GM & MAF-TM.OLYMPUS Corporation of the AmericasEOQ
Z-2494-2023Class IIOlympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.OLYMPUS Corporation of the AmericasPSV
Z-2493-2023Class IIOlympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180.OLYMPUS Corporation of the AmericasEOQ
Z-2492-2023Class IIOlympus Bronchovideoscope, Model BF-Q180-ACOLYMPUS Corporation of the AmericasEOQ
Z-2491-2023Class IIOlympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60.OLYMPUS Corporation of the AmericasEOQ
Z-2490-2023Class IIOlympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2...OLYMPUS Corporation of the AmericasEOQ
Z-2467-2023Class IIEvis Exera III Duodenovideoscope Olympus Tjf-Q190vOLYMPUS Corporation of the AmericasFDT
Z-3180-2026Class IIEWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo...embecta Medical II LLCFMI
Z-3179-2026Class IIEWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated...embecta Medical II LLCFMI
Z-2519-2023Class IIM/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number...Zimmer GmbHJDI
Z-2530-2023Class IHamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilatorHamilton Medical AGCBK
Z-2529-2023Class IHamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilatorHamilton Medical AGCBK
Z-2528-2023Class IHamilton-MR1, REF: 161010, Intensive Care VentilatorHamilton Medical AGCBK
Z-2527-2023Class IHamilton-T1, REF: 161009, Intensive Care and Transport VentilatorHamilton Medical AGCBK
Z-2526-2023Class IHamilton-T1, REF: 161006, Intensive Care and Transport VentilatorHamilton Medical AGCBK
Z-2525-2023Class IHamilton-C1, REF: 161001, Portable Intensive Care VentilatorHamilton Medical AGCBK
Z-2481-2023Class IILink OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary...Waldemar Link GmbH & Co. KGLXH
Z-2521-2023Class IIIZVU Functional GI Software, REF: ZVU-3Diversatek Healthcare IncFFX
Z-2592-2023Class IIMembrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer...Sentec AGLKD
Z-2451-2023Class IIADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in...Siemens Healthcare Diagnostics Inc.JIT
Z-2449-2023Class IIThe O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D...Medtronic Navigation, IncOWB
Z-2513-2023Class IICook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous...Cook Vandergrift, Inc.DWS
Z-2444-2023Class IITRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340...Smith & Nephew, Inc.HSB
Z-2443-2023Class IITRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336...Smith & Nephew, Inc.HSB
Z-2628-2023Class IIAmbu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data...Ambu Inc.FEM
Z-2579-2023Class IIKeystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal...Keystone IndustriesLBH
Z-1583-2025Class IIZenition 70. The device is to be used in health care facilities both inside and outside...Philips Medical Systems Nederland B.V.OWB
Z-2518-2023Class IIFor intraventricular indications mainly used for operations within the brain...Aesculap IncGWG
Z-0211-2024Class IICosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable...Cosmedent, Inc.EHK
Z-2512-2023Class IIPHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective...Reichert, Inc.HKN
Z-2480-2023Class IIVisera Hysterovideoscope Olympus HYF Type VOLYMPUS Corporation of the AmericasHIH
Z-2544-2025Class IINOxBOXi Nitric Oxide Delivery SystemNoxbox LimitedMRN
Z-0452-2024Class IIFreedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built...Ihb OperationsFQO
Z-2404-2023Class IIMultiDiagnost-ElevaPhilips Medical Systems Nederland B.V.KPR
Z-2403-2023Class IIAzurionPhilips Medical Systems Nederland B.V.OWB
Z-2402-2023Class IIAllura Xper seriesPhilips Medical Systems Nederland B.V.OWB
Z-2448-2023Class IIRandox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the...Randox Laboratories, LimitedJIX
Z-0154-2024Class IIPreat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single...PREAT CorporationNHA
Z-0153-2024Class IIPreat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use...PREAT CorporationNHA
Z-0152-2024Class IIPreat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use...PREAT CorporationNHA
Z-2466-2023Class IIPORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filterAbbott MedicalCAH
Z-2511-2023Class IInfinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable...Abbott MedicalLGW
Z-2510-2023Class IInfinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable...Abbott MedicalLGW
Z-2509-2023Class IProclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable...Abbott MedicalLGW
Z-2508-2023Class IProclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The...Abbott MedicalLGW
Z-2507-2023Class IProclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The...Abbott MedicalLGW
Z-2506-2023Class IProclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7...Abbott MedicalLGW