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

59,336 records, page 9 of 1187
FDA device recalls, page 9 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2850-2026Class IIBrand Name: Quantum Rehab Product Name: Q6 Edge 4 Model/Catalog Number: Q6 Edge...Pride Mobility Products CorpITI
Z-2849-2026Class IIBrand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 Edge...Pride Mobility Products CorpITI
Z-2848-2026Class IIBrand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Model/Catalog Number: Q6...Pride Mobility Products CorpITI
Z-2847-2026Class IIBrand Name: Quantum Rehab Product Name: Quantum 1450 Model/Catalog Number: Quantum...Pride Mobility Products CorpITI
Z-2846-2026Class IIBrand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q6 Edge...Pride Mobility Products CorpITI
Z-2845-2026Class IIBrand Name: Quantum Rehab Product Name: Q6 Edge HD Model/Catalog Number: Q6 Edge...Pride Mobility Products CorpITI
Z-2844-2026Class IIBrand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software...Pride Mobility Products CorpITI
Z-2843-2026Class IIBrand Name: Quantum Rehab Product Name: Q6 Edge 3 Stretto Model/Catalog Number: Q6 Edge 3...Pride Mobility Products CorpITI
Z-2842-2026Class IIBrand Name: Quantum Rehab Product Name: Quantum Outback Model/Catalog Number: Quantum...Pride Mobility Products CorpITI
Z-2841-2026Class IIBrand Name: Quantum Rehab Product Name: Quantum 4Front 2 Model/Catalog Number: Quantum...Pride Mobility Products CorpITI
Z-3119-2026Class IIProducts that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System...C.R. Bard IncKNX
Z-3118-2026Class IIProducts that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley...C.R. Bard IncKNX
Z-3117-2026Class IIProducts that contain the Pericare Wipes: SureStep Intermittent Catheter...C.R. Bard IncKOD
Z-3116-2026Class IIProducts that contain the Pericare Wipes: *Bardex I.C. Complete Care Foley Catheter...C.R. Bard IncMJC
Z-3115-2026Class IIProducts that contain the Pericare Wipes: Bard Foley Tray With Lubri-Sil All-Silicone...C.R. Bard IncEZL
Z-3114-2026Class IIProducts that contain the Pericare Wipes: Bardex Lubricath Foley Catheter...C.R. Bard IncEZC
Z-2922-2026Class IISurgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GXMedtronic, Inc.GAW
Z-2921-2026Class IISurgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623Medtronic, Inc.GAW
Z-2920-2026Class IIDermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0...Medtronic, Inc.GAR
Z-2919-2026Class IIV-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS...Medtronic, Inc.GAM
Z-2918-2026Class IIV-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0...Medtronic, Inc.GAM
Z-2860-2026Class IIFlow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i...Maquet Critical Care ABBSZ
Z-2811-2026Class IIEOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an...Medtronic Perfusion SystemsDWF
Z-2810-2026Class IIEOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an...Medtronic Perfusion SystemsDWF
Z-2809-2026Class IIEOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with...Medtronic Perfusion SystemsDWF
Z-2808-2026Class IIEOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with...Medtronic Perfusion SystemsDWF
Z-2807-2026Class IIEOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with...Medtronic Perfusion SystemsDWF
Z-2806-2026Class IIEOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with...Medtronic Perfusion SystemsDWF
Z-2759-2026Class IIHotline Fluid Warming Set, single use device, is designed to warm blood and intravenous...Abbott MedicalLGZ
Z-2936-2026Class IIBIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based...BioFire Diagnostics, LLCQOF
Z-2958-2026Class IIArrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533...Arrowhead de LLCHTY
Z-2835-2026Class IICharger for the Therabody Theragun, G4 PRO massage device, and products which include the...Therabody, Inc.ISA
Z-2856-2026Class IImunevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control...Munevo GmbHKNN
Z-2760-2026Class IIPower F2 Powered Fastening System, Product No. 0567091 Powered fastening system intended...Ferno-Washington IncFPO
Z-2771-2026Class IIBoston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001...Boston Scientific CorporationLLZ
Z-2893-2026Class IIPhilips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional...Philips Medical Systems Nederland B.V.OWB
Z-2892-2026Class IIPhilips Azurion under the following System Descriptions and corresponding model numbers...Philips Medical Systems Nederland B.V.OWB
Z-2819-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part...Windstone Medical Packaging, Inc.OKE
Z-2818-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder...Windstone Medical Packaging, Inc.LRO
Z-2817-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part...Windstone Medical Packaging, Inc.OJG
Z-2816-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX...Windstone Medical Packaging, Inc.OES
Z-2815-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part...Windstone Medical Packaging, Inc.OEQ
Z-2814-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray...Windstone Medical Packaging, Inc.OGJ
Z-2813-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu...Windstone Medical Packaging, Inc.OGE
Z-2812-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part...Windstone Medical Packaging, Inc.OFT
Z-2768-2026Class IIVentriculostomy Kit, REF: 46154Medtronic NeurosurgeryHBG
Z-2891-2026Class IIPhilips Allura under the following System Descriptions and corresponding model numbers...Philips Medical Systems Nederland B.V.OWB
Z-2910-2026Class IIBlom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LFFreudenberg Medical, LLCEWL
Z-2909-2026Class IIBlom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEFFreudenberg Medical, LLCEWL
Z-2758-2026Class IIP28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod...Paragon 28HXI