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 68 of 1190
FDA device recalls, page 68 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2592-2025Class ISterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0408-2026Class IIGreiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322Greiner Bio-One North America, Inc.GIM
Z-2672-2025Class IIArgus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006Schiller, AGMHX
Z-2594-2025Class IIBaster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck...Baxter Healthcare CorporationFPA
Z-2495-2025Class IIRayStation with the following product descriptions: 1. RayStation 2023B, Software...RaySearch Laboratories AB (publ)MUJ
Z-2494-2025Class IIRayStation with the following product descriptions: 1. RayStation 6 Service Pack 1...RaySearch Laboratories AB (publ)MUJ
Z-2493-2025Class IIRayStation with the following product descriptions: 1. RayStation 12A, Software...RaySearch Laboratories AB (publ)MUJ
Z-2492-2025Class IIRayStation with the following product descriptions: 1. RayStation 11B, Software...RaySearch Laboratories AB (publ)MUJ
Z-2491-2025Class IIRayStation with the following product descriptions: 1. RayStation 11A, Software...RaySearch Laboratories AB (publ)MUJ
Z-2490-2025Class IIRayStation with the following product descriptions: 1. RayStation 10B, Software...RaySearch Laboratories AB (publ)MUJ
Z-2489-2025Class IIRayStation with the following product descriptions: 1. RayStation 9B, Software Version...RaySearch Laboratories AB (publ)MUJ
Z-2488-2025Class IIRayStation with the following product descriptions: 1. RayStation 8B, Software Version...RaySearch Laboratories AB (publ)MUJ
Z-2487-2025Class IIRayStation with the following product descriptions: 1. RayStation 7, Software Version...RaySearch Laboratories AB (publ)MUJ
Z-2543-2025Class IIIntelliSpace Cardiovascular, Software 8.0.0.4.Philips Medical Systems Nederland B.V.LLZ
Z-2517-2025Class IIIFloPatch FP120, REF: FP120-FOT01-005Flosonics Medical (R/A 1929803 ONTARIO Corp.)DPW
Z-0414-2026Class IIXpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA...CepheidNQX
Z-2636-2025Class IIVasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The...Maquet Cardiovascular LLCGEI
Z-2527-2025Class IISmiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with...Abbott MedicalFPA
Z-2526-2025Class IISmiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer...Abbott MedicalFPA
Z-2525-2025Class IISmiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer...Abbott MedicalFPA
Z-2524-2025Class IISmiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and...Abbott MedicalFPA
Z-2523-2025Class IISmiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented...Abbott MedicalFPA
Z-2522-2025Class IISmiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented...Abbott MedicalFPA
Z-2484-2025Class IViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot...OLYMPUS Corporation of the AmericasKTI
Z-2482-2025Class IDLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT...Medtronic Perfusion SystemsDWF
Z-2481-2025Class IDLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT...Medtronic Perfusion SystemsDWF
Z-2480-2025Class IDLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT...Medtronic Perfusion SystemsDWF
Z-2554-2025Class IIReef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody SystemSeaSpine Orthopedics CorporationMAX
Z-0308-2026Class IIBrand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and...Alcon LaboratoriesNGY
Z-0307-2026Class IIBrand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and...Alcon LaboratoriesMPA
Z-0306-2026Class IIBrand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and...Alcon LaboratoriesHQE
Z-0305-2026Class IIBrand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and...Alcon LaboratoriesHQC
Z-0304-2026Class IIBrand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and...Alcon LaboratoriesMLZ
Z-2512-2025Class IIBrand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613...Integra LifeSciences CorporationFRO
Z-2511-2025Class IIBrand Name: MediHoney Product Name: MediHoney HCS Surgical Adhesive Sheet Model/Catalog...Integra LifeSciences CorporationFRO
Z-2510-2025Class IIBrand Name: MediHoney Product Name: MediHoney Hydrogel Adhesive Sheet Model/Catalog...Integra LifeSciences CorporationFRO
Z-2509-2025Class IIBrand Name: MediHoney Product Name: MediHoney Hydrogel Model/Catalog Number: 31620...Integra LifeSciences CorporationFRO
Z-2508-2025Class IIBrand Name: MediHoney Product Name: MediHoney Adhesive Hydrogel Sheet...Integra LifeSciences CorporationFRO
Z-2507-2025Class IIBrand Name: MediHoney Product Name: MediHoney HCS Sheet Dressing with...Integra LifeSciences CorporationFRO
Z-2506-2025Class IIBrand Name: MediHoney Product Name: MediHoney Tube Model/Catalog Number: 31515 and...Integra LifeSciences CorporationFRO
Z-2505-2025Class IIBrand Name: MediHoney Product Name: MediHoney Paste Model/Catalog Number: 31505 Product...Integra LifeSciences CorporationFRO
Z-0232-2026Class IIt:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF...Tandem Diabetes Care, Inc.QFG
Z-2536-2025Class IIBoston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200...Boston Scientific CorporationEZN
Z-2535-2025Class IIBoston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180...Boston Scientific CorporationLJE
Z-2534-2025Class IIBoston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011...Boston Scientific CorporationMAV
Z-2533-2025Class IIBoston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011...Boston Scientific CorporationPTM
Z-2570-2025Class IIPinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5...Philips North America LLCMUJ
Z-2478-2025Class IIWasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product...Wasatch PhotonicsREM
Z-2531-2025Class IIHalyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-2530-2025Class IIHalyard, ENT PACK. Model Number: JACK421-04. Convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305LRO