510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

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 134 of 1190
FDA device recalls, page 134 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2340-2024Class II190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model...Fresenius Medical Care Renal Therapies Group, LLCKDI
Z-2261-2024Class IIThis product is a single use sterile device that is used to direct the lesion to the...Stryker Corp.GXI
Z-2260-2024Class IICurved, super elastic cement delivery needle that passes through the cannula in a...Stryker Corp.OAR
Z-2259-2024Class IIThe Non-Sterile Flyte hood covers the user s head and neck region and is intended to be...Stryker Corp.OEA
Z-2257-2024Class IINeurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation...Nalu MedicalGZF
Z-2718-2024Class IINanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the...Treace Medical Concepts, Inc.HRS
Z-3091-2024Class IparaPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300NAbbott MedicalBTL
Z-2974-2024Class IPneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXXAbbott MedicalBTL
Z-2973-2024Class IPneupac paraPAC plus 300 ventilator kit, REF P300NXXAbbott MedicalBTL
Z-3090-2024Class IparaPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310NAbbott MedicalBTL
Z-2506-2024Class IISoltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWLOLYMPUS Corporation of the AmericasGEX
Z-2505-2024Class IISoltive Pro SuperPulsed Laser System, Model TFL-SLSOLYMPUS Corporation of the AmericasGEX
Z-2504-2024Class IISoltive Premium SuperPulsed Laser System, Model TFL-PLSOLYMPUS Corporation of the AmericasGEX
Z-2319-2024Class IImpella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support...Abiomed, Inc.OZD
Z-2405-2024Class IIREF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single...Stryker Sustainability SolutionsKCY
Z-2338-2024Class IIThe VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in...Maquet Cardiovascular LLCGEI
Z-2337-2024Class IIThe VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in...Maquet Cardiovascular LLCGEI
Z-2324-2024Class IIZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator...ZOLL Medical CorporationMKJ
Z-2188-2024Class IIZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been...Siemens Medical Solutions USA, Inc.IZZ
Z-2187-2024Class IIMULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient...Siemens Medical Solutions USA, Inc.IZZ
Z-2186-2024Class IIMULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient...Siemens Medical Solutions USA, Inc.IZZ
Z-2185-2024Class IIAXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for...Siemens Medical Solutions USA, Inc.IZZ
Z-2184-2024Class IIAXIOM Vertix MD - The Vertix MD Trauma has been specially designed for...Siemens Medical Solutions USA, Inc.IZZ
Z-2183-2024Class IIAXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in conjunction...Siemens Medical Solutions USA, Inc.IZZ
Z-2182-2024Class IIAXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used...Siemens Medical Solutions USA, Inc.IZZ
Z-2181-2024Class IIAXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used...Siemens Medical Solutions USA, Inc.IZZ
Z-2180-2024Class IIAXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in...Siemens Medical Solutions USA, Inc.IZZ
Z-2426-2024Class IIABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended...Radiometer Medical ApSCHL
Z-2422-2024Class IIMIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile...Halyard HealthKNT
Z-2178-2024Class IITitan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number...Dentalez, Inc., Stardental DivisionELC
Z-2177-2024Class IITitan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an...Dentalez, Inc., Stardental DivisionELC
Z-2322-2024Class IVolara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing...Baxter Healthcare CorporationNHJ
Z-2321-2024Class IVolara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use...Baxter Healthcare CorporationNHJ
Z-2615-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL...Abbott MedicalBTO
Z-2614-2024Class Ia) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List...Abbott MedicalBTO
Z-2613-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE...Abbott MedicalBTO
Z-2612-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE...Abbott MedicalBTO
Z-2611-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE...Abbott MedicalBTO
Z-2610-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE...Abbott MedicalBTO
Z-2609-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE...Abbott MedicalBTO
Z-2608-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE...Abbott MedicalBTO
Z-2607-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE...Abbott MedicalBTO
Z-2606-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE...Abbott MedicalBTO
Z-2605-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL...Abbott MedicalBTO
Z-2604-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM...Abbott MedicalBTO
Z-2603-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE...Abbott MedicalBTO
Z-2602-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL...Abbott MedicalBTO
Z-2601-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC...Abbott MedicalBTO
Z-2600-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND...Abbott MedicalBTO
Z-2599-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM...Abbott MedicalBTO