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 74 of 1190
FDA device recalls, page 74 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2112-2025Class IILaser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.Beyond Laser Systems, LLCREA
Z-2111-2025Class IILaser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000.Beyond Laser Systems, LLCREA
Z-2189-2025Class IIPhilips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model...Philips Medical Systems Nederland B.V.OWB
Z-2174-2025Class IIHeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan...HeartSine Technologies LtdMKJ
Z-2331-2025Class IIInjection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm...Spiggle & Theis Medizintechnik GmbHGDM
Z-2195-2025Class IILYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894LMicrobiologics, Inc.JTR
Z-2194-2025Class IILYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF...Microbiologics, Inc.JTR
Z-2193-2025Class IISprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion...MAQUET CARDIOPULMONARY GmbHKRI
Z-2671-2025Class IIVITEK 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK...bioMerieux, Inc.LON
Z-2167-2025Class IBreathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF...Hamilton Medical AGBZO
Z-2230-2025Class IIRAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.Siemens Healthcare Diagnostics Inc.CHL
Z-2264-2025Class IIUIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,Siemens Healthcare Diagnostics Inc.JMO
Z-2861-2026Class IIBrand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR...Nuclein, LLCNSU
Z-1772-2026Class IIMicroScan Neg MIC 3J REF C54814Siemens Healthcare Diagnostics Inc.LTT
Z-2514-2025Class IINobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662PREAT CorporationNHA
Z-2274-2025Class IIDASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and...Nuclein, LLCQOF
Z-2278-2025Class IIFARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401Boston Scientific CorporationQZI
Z-2271-2025Class IIDxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460Siemens Healthcare Diagnostics Inc.JJE
Z-2270-2025Class IIDxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461Siemens Healthcare Diagnostics Inc.JJE
Z-2269-2025Class IIUniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260Siemens Healthcare Diagnostics Inc.JJE
Z-2268-2025Class IIDxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456Siemens Healthcare Diagnostics Inc.JJE
Z-2267-2025Class IIDxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457Siemens Healthcare Diagnostics Inc.JJE
Z-2266-2025Class IIUniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100Siemens Healthcare Diagnostics Inc.JJE
Z-2555-2025Class IIPILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SPOrthofix SRLMAX
Z-2235-2025Class IILVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site...Fresenius Kabi USA, LLCFRN
Z-2234-2025Class IILVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code...Fresenius Kabi USA, LLCFRN
Z-2233-2025Class IILVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty...Fresenius Kabi USA, LLCFRN
Z-2232-2025Class IILVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty...Fresenius Kabi USA, LLCFRN
Z-2107-2025Class IIPreat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10...PREAT CorporationNHA
Z-2291-2025Class IBrand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number...Abbott MedicalDSQ
Z-2290-2025Class IBrand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog...Abbott MedicalDSQ
Z-2162-2025Class IIBD COR System Software. Model Number: 444829.Becton Dickinson & CoMAQ
Z-2164-2025Class IAutomated Impella Controller (AIC), used in left heart support blood pump, including the...Abiomed, Inc.OZD
Z-2178-2025Class IIDual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting...STERIS CorporationFSY
Z-2177-2025Class IIDual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting...STERIS CorporationFSY
Z-2151-2025Class IICovidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N...Medtronic, Inc.DQA
Z-2098-2025Class IIVaricam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine SystemGE Medical Systems Israel, Functional ImagingKPS
Z-2097-2025Class IIInfinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine systemGE Medical Systems Israel, Functional ImagingKPS
Z-2320-2025Class IIGE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging SystemGE HealthcareLNH
Z-2319-2025Class IIGE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging SystemGE HealthcareLNH
Z-2318-2025Class IIGE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging SystemGE HealthcareLNH
Z-2317-2025Class IIGE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging SystemGE HealthcareLNH
Z-2316-2025Class IIGE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging SystemGE HealthcareLNH
Z-2315-2025Class IIGE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging SystemGE HealthcareLNH
Z-2314-2025Class IIGE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging SystemGE HealthcareLNH
Z-2313-2025Class IIGE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging SystemGE HealthcareLNH
Z-2312-2025Class IIGE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging SystemGE HealthcareLNH
Z-2311-2025Class IIGE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging SystemGE HealthcareLNH
Z-2310-2025Class IIGE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging SystemGE HealthcareLNH
Z-2309-2025Class IIGE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear...GE HealthcareLNH