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 180 of 1190
FDA device recalls, page 180 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0131-2024Class II30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.B Braun Medical IncDXT
Z-0130-2024Class IIAMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.B Braun Medical IncKYG
Z-0129-2024Class IISA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.B Braun Medical IncFPA
Z-0128-2024Class IIFT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large...B Braun Medical IncFPA
Z-1375-2024Class IIInsufflation unit, UHI-4.OLYMPUS Corporation of the AmericasHIF
Z-0348-2024Class IIUretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and...Aizu Olympus Co., Ltd.FGB
Z-0347-2024Class IIUreteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and...Aizu Olympus Co., Ltd.FCB
Z-0346-2024Class IIDuodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary...Aizu Olympus Co., Ltd.FET
Z-0345-2024Class IIUltrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle...Aizu Olympus Co., Ltd.FBN
Z-0344-2024Class IITransnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus...Aizu Olympus Co., Ltd.EOQ
Z-0343-2024Class IISmall intestinal videoscope-For endoscopy and endoscopic surgery within the upper...Aizu Olympus Co., Ltd.NWB
Z-0342-2024Class IISignmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract...Aizu Olympus Co., Ltd.NWB
Z-0341-2024Class IIColonoscope-indicated for use within the lower digestive tract (including the...Aizu Olympus Co., Ltd.NWB
Z-0340-2024Class IIMobile airway scope-diagnosis and observation to access airway...Aizu Olympus Co., Ltd.EOQ
Z-0339-2024Class IITracheal videoscope- For airway management, which includes observation to access airway...Aizu Olympus Co., Ltd.EOQ
Z-0338-2024Class IITracheal fiberscope-airway management, which includes observation to access airway...Aizu Olympus Co., Ltd.EOQ
Z-0337-2024Class IIHysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.Aizu Olympus Co., Ltd.EOQ
Z-0336-2024Class IIHysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.Aizu Olympus Co., Ltd.HIH
Z-0335-2024Class IIHysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.Aizu Olympus Co., Ltd.HIH
Z-0334-2024Class IIGastrointestinal videoscope-indicated for use within the upper digestive tract (including...Aizu Olympus Co., Ltd.FDF
Z-0333-2024Class IIGastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for...Aizu Olympus Co., Ltd.ITX
Z-0332-2024Class IIRhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and...Aizu Olympus Co., Ltd.EOQ
Z-0331-2024Class IICystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and...Aizu Olympus Co., Ltd.FAJ
Z-0330-2024Class IICholeodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.Aizu Olympus Co., Ltd.FBO
Z-0329-2024Class IIColonoscope: for endoscopy and endoscopic surgery within the lower digestive tract...Aizu Olympus Co., Ltd.FET
Z-0328-2024Class IIBronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided...Aizu Olympus Co., Ltd.PSV
Z-0327-2024Class IIBronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial...Aizu Olympus Co., Ltd.EOQ
Z-0282-2024Class IIRSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic...Encore Medical, LPPHX
Z-0281-2024Class IIRSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432...Encore Medical, LPKWS
Z-0222-2024Class IIArial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59362; mobile...Securitas Healthcare LLCIQA
Z-0221-2024Class IIArial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile...Securitas Healthcare LLCIQA
Z-0220-2024Class IIArial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile...Securitas Healthcare LLCIQA
Z-0672-2024Class IISPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking...Thuasne, LLCIQI
Z-0671-2024Class IISPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference...Thuasne, LLCIQI
Z-0670-2024Class IICUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000...Thuasne, LLCIQI
Z-0323-2024Class IIDBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created...Musculoskeletal Transplant Foundation d/b/a/ MTF BiologicsMQV
Z-0075-2024Class IOlympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.OLYMPUS Corporation of the AmericasHIF
Z-0315-2024Class IIRegard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kitROi CPS LLCOEZ
Z-0280-2024Class IIProxiDiagnost N90, Radiography and Fluoroscopy (R/F) systemPhilips North America LLCJAA
Z-0279-2024Class IIEasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export...Philips North America LLCJAA
Z-0278-2024Class IIDigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export...Philips North America LLCJAA
Z-0277-2024Class IIDigitalDiagnost C90 Release 3, used to acquire, process, store, display and export...Philips North America LLCJAA
Z-0276-2024Class IIDigitalDiagnost C90 High Performance, used to acquire, process, store, display and export...Philips North America LLCJAA
Z-0275-2024Class IIDigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and...Philips North America LLCJAA
Z-0274-2024Class IIDigitalDiagnost 4 High Performance, used to acquire, process, store, display and export...Philips North America LLCJAA
Z-0273-2024Class IIDigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital...Philips North America LLCJAA
Z-0272-2024Class IIDigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export...Philips North America LLCKPR
Z-0271-2024Class IICombiDiagnost R90, Radiography and Fluoroscopy (R/F) systemPhilips North America LLCJAA
Z-0291-2024Class IIAtrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for...Atrium Medical CorporationPRL
Z-0127-2024Class IITruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi...Acclarent IncPGW