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

59,336 records, page 8 of 1187
FDA device recalls, page 8 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2955-2026Class IICardiac Workstation 5000. Product Number: 860439.Philips North America LLCDPS
Z-2871-2026Class IIIntramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description...Zimmer GmbHLXH
Z-2870-2026Class IIIntramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description...Zimmer GmbHLXH
Z-2869-2026Class IIIntramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description...Zimmer GmbHLXH
Z-2868-2026Class IIIntramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description...Zimmer GmbHLXH
Z-2867-2026Class IIIntramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description...Zimmer GmbHLXH
Z-2896-2026Class II5-PLASMA Bivalirudin Control, Model Number 5D-44905Aniara Diagnostica LLCGGN
Z-2895-2026Class II5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905Aniara Diagnostica LLCJIX
Z-2894-2026Class II5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905Aniara Diagnostica LLCJIT
Z-2833-2026Class IIStryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.Stryker Corp.KTT
Z-2832-2026Class IIStryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120.Stryker Corp.KTT
Z-2831-2026Class IIStryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.Stryker Corp.KTT
Z-2830-2026Class IIStryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.Stryker Corp.KTT
Z-2829-2026Class IIStryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050.Stryker Corp.KTT
Z-2828-2026Class IIStryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.Stryker Corp.KTT
Z-2827-2026Class IIStryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.Stryker Corp.KTT
Z-2963-2026Class IIGETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous...Maquet Critical Care ABCBK
Z-3017-2026Class IIFresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126...Fresenius Medical Care Renal Therapies Group, LLCKDI
Z-2926-2026Class IIMedline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product...MEDLINE INDUSTRIES, LP - NorthfieldLRJ
Z-2925-2026Class IIMedline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number...MEDLINE INDUSTRIES, LP - NorthfieldLRJ
Z-2924-2026Class IIMedline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number...MEDLINE INDUSTRIES, LP - NorthfieldLRJ
Z-2923-2026Class IIMedline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product...MEDLINE INDUSTRIES, LP - NorthfieldLRJ
Z-2775-2026Class IISnapshotGLO Wound Imaging Device, Model KB100, KB100AA.Kent Imaging IncQJF
Z-2987-2026Class IIBrand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard...restor3d, Inc.PHX
Z-2875-2026Class IIMerge OrthoPACS, medical imaging diagnostic workstationMerge Healthcare IncorporatedLLZ
Z-2874-2026Class IIMerge PACS, medical imaging diagnostic workstationMerge Healthcare IncorporatedLLZ
Z-2766-2026Class IBaxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution...Baxter Healthcare CorporationFPA
Z-2725-2026Class IIRapid Refill Continuous Injection System, UPN M00566001Boston Scientific CorporationKYZ
Z-2840-2026Class IIRadial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4...Boston Scientific CorporationFCL
Z-2839-2026Class IIRadial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1...Boston Scientific CorporationFCL
Z-2838-2026Class IIRadial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and...Boston Scientific CorporationFCL
Z-3003-2026Class IIAmerican Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90HAmerican Contract Systems, Inc.OEZ
Z-3002-2026Class IIAmerican Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10APAmerican Contract Systems, Inc.OEZ
Z-3001-2026Class IIAmerican Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10ANAmerican Contract Systems, Inc.OEZ
Z-3000-2026Class IIAmerican Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AMAmerican Contract Systems, Inc.OEZ
Z-2876-2026Class IIGE Healthcare MAC VU360, REF# part number 2030361-023; ElectrocardiographGE Medical Systems Information Technologies, Inc.DPS
Z-2928-2026Class IIAllura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039...Philips Medical Systems Nederland B.V.OWB
Z-2911-2026Class IINeuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated...Contego Medical, IncNIM
Z-2988-2026Class IIPhilips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.Philips Healthcare (Suzhou) Co., Ltd.JAK
Z-2881-2026Class IIISyva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No...Siemens Healthcare Diagnostics Inc.LFG
Z-2880-2026Class IIISyva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319ULSiemens Healthcare Diagnostics Inc.KLR
Z-2917-2026Class IIBoston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP...Galt Medical CorpDQX
Z-2889-2026Class IIREF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following...Siemens Healthcare Diagnostics Inc.LON
Z-2888-2026Class IIREF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the...Siemens Healthcare Diagnostics Inc.LON
Z-2938-2026Class IIERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000Erbe USA IncGEH
Z-3326-2026Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code...Micro Therapeutics, Inc.OUT
Z-2735-2026Class IResmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides...ResMed CorpCBK
Z-2853-2026Class IIBrand Name: Quantum Rehab Product Name: Quantum Rival Model/Catalog Number: Quantum...Pride Mobility Products CorpITI
Z-2852-2026Class IIBrand Name: Quantum Rehab Product Name: 4Front Model/Catalog Number: 4Front Software...Pride Mobility Products CorpITI
Z-2851-2026Class IIBrand Name: Quantum Rehab Product Name: Quantum 4Front 2HD Model/Catalog Number: Quantum...Pride Mobility Products CorpITI