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 66 of 1190
FDA device recalls, page 66 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0460-2026Class IIBrand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software...Sonesta Medical ABIXR
Z-0231-2026Class IIMAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel...GE HealthcareDPS
Z-2608-2025Class IIVoyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day...CooperVision, Inc.MVN
Z-2607-2025Class IISofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54%...CooperVision, Inc.MVN
Z-2606-2025Class IIMyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water...CooperVision, Inc.MVN
Z-2670-2025Class IMedline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-2581-2025Class IIFrontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only...Folsom Metal Products, Inc.GCZ
Z-2580-2025Class IIFrontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only...Folsom Metal Products, Inc.GCZ
Z-2579-2025Class IIFrontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only...Folsom Metal Products, Inc.GCZ
Z-2578-2025Class IIFrontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, SterileFolsom Metal Products, Inc.GCZ
Z-2577-2025Class IIFrontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only...Folsom Metal Products, Inc.GCZ
Z-2576-2025Class IIFrontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only...Folsom Metal Products, Inc.GCZ
Z-2585-2025Class IIi-STAT EG6+ cartridge. List Number: 03P77-25.Abbott MedicalCHL
Z-2584-2025Class IIi-STAT EG7+ cartridge. List Number: 03P76-25.Abbott MedicalCHL
Z-2583-2025Class IIi-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918...Abbott MedicalCHL
Z-2582-2025Class IIi-STAT CG4+ cartridge (white). List Number: 03P85-25.Abbott MedicalCHL
Z-2638-2025Class IIVenclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify...Bard Peripheral Vascular IncGEI
Z-0105-2026Class IModel Number U228, VISIONIST CRT-P EL MRIBoston Scientific CorporationNKE
Z-0104-2026Class IModel Number U226, VISIONIST CRT-P ELBoston Scientific CorporationNKE
Z-0103-2026Class IModel Number U225 VISIONIST CRT-P ELBoston Scientific CorporationNKE
Z-0102-2026Class IModel Number U128, VALITUDE CRT-P EL MRIBoston Scientific CorporationNKE
Z-0101-2026Class IModel Number U125, VALITUDE CRT-P ELBoston Scientific CorporationNKE
Z-0100-2026Class IModel Number S722, ALTRUA 2 DR EL PacemakerBoston Scientific CorporationLWP
Z-0099-2026Class IModel Number S702, ALTRUA 2 DR SL PacemakerBoston Scientific CorporationLWP
Z-0098-2026Class IModel Number S701 ALTRUA 2 SR SL PacemakerBoston Scientific CorporationLWP
Z-0097-2026Class IModel Number L131, ESSENTIO DR EL MRI PacemakerBoston Scientific CorporationLWP
Z-0096-2026Class IModel Number L121 ESSENTIO DR EL PacemakerBoston Scientific CorporationLWP
Z-0095-2026Class IModel Number L111, ESSENTIO DR SL MRI PacemakerBoston Scientific CorporationLWP
Z-0094-2026Class IModel Number L110, ESSENTIO SR SL MRI PacemakerBoston Scientific CorporationLWP
Z-0093-2026Class IModel Number L101, ESSENTIO DR SL PacemakerBoston Scientific CorporationLWS
Z-0092-2026Class IModel Number L100, ESSENTIO SR SL PacemakerBoston Scientific CorporationLWP
Z-0091-2026Class IModel Number L231, PROPONENT DR EL MRI PacemakerBoston Scientific CorporationLWP
Z-0090-2026Class IModel Number L221 PROPONENT DR EL PacemakerBoston Scientific CorporationLWP
Z-0089-2026Class IModel Number L211 PROPONENT DR SL MRI PacemakerBoston Scientific CorporationLWP
Z-0088-2026Class IModel Number L210 PROPONENT SR SL PacemakerBoston Scientific CorporationLWP
Z-0087-2026Class IModel Number L209 PROPONENT DR (VDD) SL PacemakerBoston Scientific CorporationLWP
Z-0086-2026Class IPROPONENT DR SL (Model L201)Boston Scientific CorporationLWP
Z-0085-2026Class IPROPONENT SR SL (Model L200)Boston Scientific CorporationLWP
Z-0084-2026Class IACCOLADE DR EL MRI (Model L331)Boston Scientific CorporationLWP
Z-0083-2026Class IACCOLADE DR EL (Model L321)Boston Scientific CorporationLWP
Z-0082-2026Class IACCOLADE DR SL MRI (Model L311)Boston Scientific CorporationLWP
Z-0081-2026Class IACCOLADE SR SL MRI (Model L310)Boston Scientific CorporationLWP
Z-0411-2026Class IIMST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction...MicroSurgical Technology IncHNN
Z-0080-2026Class IACCOLADE DR SL (Model L301)Boston Scientific CorporationLWP
Z-0079-2026Class IACCOLADE SR SL (Model L300)Boston Scientific CorporationLWP
Z-2568-2025Class IAutomated Impella Controller (AIC) with the below brands and product codes. Used with...Abiomed, Inc.OZD
Z-0571-2026Class IIBrand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog...Greiner Bio-One North America, Inc.JKA
Z-0040-2026Class IIEverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm...Corneat Vision, Ltd.QWU
Z-0039-2026Class IICorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x...Corneat Vision, Ltd.QWU
Z-0027-2026Class IIAESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.Aesculap IncHBB