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 183 of 1190
FDA device recalls, page 183 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0182-2024Class IICath Cardiac Pack, REF IHCC03VAmerican Contract Systems, Inc.NWU
Z-0181-2024Class IIPediatric Urology Wolson Pack, REF BPPU55AAmerican Contract Systems, Inc.NWU
Z-0180-2024Class IISub Q Recorder Pack, REF BPRC87AAmerican Contract Systems, Inc.OES
Z-0179-2024Class IIRobotics Pack, REF SSRO22DAmerican Contract Systems, Inc.LRO
Z-0178-2024Class IIRobotics Pack, REF SJVO56BAmerican Contract Systems, Inc.LRO
Z-0177-2024Class IIVasc. Open CVOR SJH, REF SJVO56BAmerican Contract Systems, Inc.OEZ
Z-0176-2024Class IIPediatric Heart SJH, REF SJPH34KAmerican Contract Systems, Inc.OEZ
Z-0175-2024Class IICvs Pcsu Sjh, Ref Sjcv48jAmerican Contract Systems, Inc.LRO
Z-0174-2024Class IIRobotics Pack SAH, REF SAR530MAmerican Contract Systems, Inc.FDE
Z-0173-2024Class IIBreast Plastics Pack, REF BBPL20DAmerican Contract Systems, Inc.FTN
Z-0172-2024Class IILavh, Ref Bblv21cAmerican Contract Systems, Inc.OJF
Z-0171-2024Class IIGeneral Pack, REF BBGP31CAmerican Contract Systems, Inc.LRO
Z-2648-2023Class II(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra...Siemens Medical Solutions USA, Inc.LNH
Z-0235-2024Class IIZephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LPPULMONX, Corp.NJK
Z-0115-2024Class IIHydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004Access Vascular, IncLJS
Z-0114-2024Class IIHydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002Access Vascular, IncLJS
Z-2655-2023Class IIEarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2)...Philips North America LLCDSJ
Z-2654-2023Class IIEarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and...Philips North America LLCDSJ
Z-2621-2023Class IIsmith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N...Smith & Nephew, Inc.JWH
Z-0436-2024Class IIProCurity bed series, model number 3009, item number: 3009PX-ZX-450.Stryker MedicalFNL
Z-0435-2024Class IIProCurity bed series, model number 3009, item number: 3009PX-ZMX-600.Stryker MedicalFNL
Z-0434-2024Class IIProCurity bed series, model number 3009, item number: 3009PX-ZMX-450.Stryker MedicalFNL
Z-0433-2024Class IIProCuity bed series, model number 3009, item number: 3009PX-ZM-600.Stryker MedicalFNL
Z-0432-2024Class IIProCuity bed series, model number 3009, item number: 3009PX-ZM-450.Stryker MedicalFNL
Z-0431-2024Class IIProCuity bed series, model number 3009, item number: 3009PX-Z-450.Stryker MedicalFNL
Z-0430-2024Class IIProCuity bed series, model number 3009, item number: 3009PX-LEX-450.Stryker MedicalFNL
Z-0429-2024Class IIProCuity bed series, model number 3009, item number: 3009PX-LEX-400.Stryker MedicalFNL
Z-0428-2024Class IIProCuity bed series, model number 3009, item number: 3009PX-LE-450.Stryker MedicalFNL
Z-0427-2024Class IIProCuity bed series, model number 3009, item number: 3009PX-LE-400.Stryker MedicalFNL
Z-0426-2024Class IIProCuity bed series, model number 3009, item number: 3009PX-L-200Stryker MedicalFNL
Z-0425-2024Class IIProCuity bed series, model number 3009, item number: 3009PX-L-100.Stryker MedicalFNL
Z-0424-2024Class IIProCuity bed series, model number 3009, item number: 300900000000,Stryker MedicalFNL
Z-0040-2024Class IICitrine Triple Quad Mass Spectrometer, Part Number 5063684AB Sciex, LLCDOP
Z-0039-2024Class IICitrine QTRAP Mass Spectrometer, Part Number 5063685AB Sciex, LLCDOP
Z-0038-2024Class II4500MD Triple Quad Mass Spectrometer, Part Number 5032522AB Sciex, LLCDOP
Z-0037-2024Class IIAPI3200MD Mass Spectrometer, Part Number 4466230AB Sciex, LLCDOP
Z-0082-2024Class IICellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound...RoyalVibe Health Ltd.OHV
Z-0985-2024Class IIBox as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box...CooperSurgical, Inc.GCJ
Z-0726-2024Class IIPRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product...Limacorporate S.p.A.MBF
Z-0612-2024Class IIArjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and...ArjoHuntleigh Polska Sp. zo.o.FNL
Z-0611-2024Class IIArjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and...ArjoHuntleigh Polska Sp. zo.o.FNL
Z-0074-2024Class IICoventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and...FLOWER ORTHOPEDICS Corporation dba Conventus FlowerHSB
Z-0025-2024Class IIREF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN...Becton Dickinson Infusion Therapy Systems Inc.FOZ
Z-0702-2024Class IIDetector H. Pylori, Catalog Number IHP-30Immunostics, Inc.LYR
Z-0632-2024Class IIConventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807Becton Dickinson & CoHNN
Z-0106-2024Class IIMultichem P, Part Code 08P90-10Techno-Path Manufacturing Ltd.JJY
Z-0105-2024Class IIMultichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19Techno-Path Manufacturing Ltd.JJY
Z-0104-2024Class IIMultichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12Techno-Path Manufacturing Ltd.JJY
Z-2631-2023Class IPhilips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device...Respironics, Inc.MNT
Z-0187-2024Class IIAZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324Terumo Cardiovascular Systems CorporationKRD