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 132 of 1190
FDA device recalls, page 132 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2481-2024Class IISIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance...GE HealthcareLNH
Z-2480-2024Class IISIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance...GE HealthcareLNH
Z-2479-2024Class IISIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging...GE HealthcareLNH
Z-2478-2024Class IIOptima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear...GE HealthcareLNH
Z-2477-2024Class IIBrivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear...GE HealthcareLNH
Z-2476-2024Class IISIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance...GE HealthcareLNH
Z-2475-2024Class IISIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance...GE HealthcareLNH
Z-2474-2024Class IISIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance...GE HealthcareLNH
Z-2473-2024Class IISIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1...GE HealthcareLNH
Z-2472-2024Class IISIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03...GE HealthcareLNH
Z-2471-2024Class II1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4...GE HealthcareLNH
Z-2470-2024Class IISIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1...GE HealthcareLNH
Z-2469-2024Class IISIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0...GE HealthcareLNH
Z-2468-2024Class IIOptima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0...GE HealthcareLNH
Z-2467-2024Class IIDiscovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0...GE HealthcareLNH
Z-2466-2024Class IISIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1...GE HealthcareOUO
Z-2465-2024Class IIDiscovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0...GE HealthcareLNH
Z-2464-2024Class IIDiscovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to...GE HealthcareLNH
Z-2463-2024Class II3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0...GE HealthcareLNH
Z-2462-2024Class IISIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to...GE HealthcareLNH
Z-2461-2024Class IISIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic...GE HealthcareLNH
Z-2460-2024Class IISIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX26.1, PX28.0...GE HealthcareLNH
Z-2459-2024Class IISIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3...GE HealthcareLNH
Z-2355-2024Class IINitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability...Medical Depot Inc.ITJ
Z-2354-2024Class IINitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability...Medical Depot Inc.ITJ
Z-2539-2024Class IIHookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the...STERIS CorporationFEB
Z-2538-2024Class IIHookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the...STERIS CorporationFEB
Z-2537-2024Class IIHookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the...STERIS CorporationFEB
Z-2536-2024Class IIHookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface...STERIS CorporationFEB
Z-2373-2024Class IIHorizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI...Hologic, Inc.KGI
Z-2339-2024Class IIBraun Thermoscan PRO 6000 Ear ThermometerBaxter Healthcare CorporationFLL
Z-2350-2024Class IIAutotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170...Boston Scientific CorporationKNS
Z-2254-2024Class IBAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration...Synergetics IncKDD
Z-2253-2024Class IBAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of...Synergetics IncKDD
Z-2252-2024Class IBAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of...Synergetics IncKDD
Z-2251-2024Class IBAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal...Synergetics IncKDD
Z-3129-2024Class IIFoam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060...Medical Action Industries, Inc. 306FSM
Z-2579-2024Class IIVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical...Merit Medical Systems, Inc.OEQ
Z-2578-2024Class IIVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical...Merit Medical Systems, Inc.OEZ
Z-2577-2024Class IIVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical...Merit Medical Systems, Inc.DYB
Z-2576-2024Class IIVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical...Merit Medical Systems, Inc.PYC
Z-2575-2024Class IIVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical...Merit Medical Systems, Inc.DYB
Z-2574-2024Class IIVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical...Merit Medical Systems, Inc.DYB
Z-2573-2024Class IIVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical...Merit Medical Systems, Inc.OEQ
Z-2572-2024Class IIVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical...Merit Medical Systems, Inc.DYB
Z-2571-2024Class IIVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical...Merit Medical Systems, Inc.DYB
Z-2570-2024Class IIVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical...Merit Medical Systems, Inc.JOL
Z-2569-2024Class IIVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical...Merit Medical Systems, Inc.PXU
Z-2568-2024Class IIVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical...Merit Medical Systems, Inc.OEQ
Z-2567-2024Class IIVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical...Merit Medical Systems, Inc.OEQ