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 67 of 1190
FDA device recalls, page 67 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0026-2026Class IIAESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.Aesculap IncHBB
Z-2551-2025Class IIPreventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000Boston Scientific CorporationGEH
Z-2550-2025Class IIICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material...Boston Scientific CorporationGEH
Z-2562-2025Class IIExactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER...Exactech, Inc.PHX
Z-2561-2025Class IIExactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM...Exactech, Inc.PHX
Z-2605-2025Class IISTRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI...Ethicon, IncNEW
Z-2588-2025Class IIHeartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.Maquet Cardiovascular LLCDXC
Z-2587-2025Class IIHeartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.Maquet Cardiovascular LLCDXC
Z-2586-2025Class IIHeartstring III Proximal Seal System. Intravascular anastomosis occluder.Maquet Cardiovascular LLCDXC
Z-2622-2025Class IIBeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014...Datascope Corp.MHX
Z-1809-2026Class IIiLet Ace Pump Kit REF: BB1001 iLet Dosing Decision SoftwareBeta Bionics, Inc.QFG
Z-1508-2026Class IIIPenner Pacific Bathing Spa, Model Numbers 860010-1LPenner Patient Care, IncILJ
Z-1507-2026Class IIIPenner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1Penner Patient Care, IncILJ
Z-1506-2026Class IIIPenner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XLPenner Patient Care, IncILJ
Z-1505-2026Class IIIPenner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2Penner Patient Care, IncILJ
Z-1504-2026Class IIIPenner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA...Penner Patient Care, IncILJ
Z-1503-2026Class IIIPenner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE...Penner Patient Care, IncILJ
Z-1502-2026Class IIIPenner Pacific Bathing Spa, Model Numbers 360020-1PPenner Patient Care, IncILJ
Z-1501-2026Class IIIPenner Pacific Bathing Spa, Model Numbers 360020-1EPPenner Patient Care, IncILJ
Z-1500-2026Class IIIPenner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT...Penner Patient Care, IncILJ
Z-1499-2026Class IIIPenner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-XPenner Patient Care, IncILJ
Z-0030-2026Class IIChange Healthcare Radiology Solutions software version 14.2.2Change Healthcare Canada CompanyLLZ
Z-2604-2025Class IIPhilips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.Philips North America LLCJAK
Z-2603-2025Class IIPhilips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model...Philips North America LLCJAK
Z-2602-2025Class IIPhilips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model...Philips North America LLCJAK
Z-2601-2025Class IIPhilips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.Philips North America LLCJAK
Z-2600-2025Class IIPhilips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number...Philips North America LLCJAK
Z-2599-2025Class IIPhilips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.Philips North America LLCJAK
Z-2598-2025Class IIPhilips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.Philips North America LLCJAK
Z-2597-2025Class IIPhilips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2...Philips North America LLCJAK
Z-2596-2025Class IIPhilips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number...Philips North America LLCJAK
Z-2595-2025Class IIPhilips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number...Philips North America LLCJAK
Z-2575-2025Class IIUniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB...Siemens Healthcare Diagnostics Inc.GKZ
Z-2574-2025Class IIUniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB...Siemens Healthcare Diagnostics Inc.GKZ
Z-2573-2025Class IIUniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB...Siemens Healthcare Diagnostics Inc.GKZ
Z-2572-2025Class IIUniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB...Siemens Healthcare Diagnostics Inc.GKZ
Z-0130-2026Class IINutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 90, REF E...Applied Medical Technology IncKNT
Z-0129-2026Class IINutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E...Applied Medical Technology IncKNT
Z-0128-2026Class IINutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 90, REF E...Applied Medical Technology IncKNT
Z-0127-2026Class IINutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E...Applied Medical Technology IncKNT
Z-2529-2025Class IIArtis Pheno. Image-Intensified Flouroscopic X-Ray System.Siemens Medical Solutions USA, Inc.OWB
Z-2540-2025Class IMax Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in...Permobil, ABITI
Z-2539-2025Class IMax Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction...Permobil, ABITI
Z-2538-2025Class IMax Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction...Permobil, ABITI
Z-2518-2025Class IIMerge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and...Merge Healthcare IncorporatedDQK
Z-2565-2025Class IIBrand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako...Agilent Technologies Denmark ApSNJT
Z-2564-2025Class IIBrand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako...Agilent Technologies Denmark ApSNJT
Z-2563-2025Class IIBrand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako...Agilent Technologies Denmark ApSNJT
Z-2542-2025Class IIAtellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.Siemens Healthcare Diagnostics Inc.CEK
Z-2593-2025Class ISterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701BMEDLINE INDUSTRIES, LP - NorthfieldOJH