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
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-2380-2015 | Class II | AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using... | Boston Scientific Corporation | DXE | |
| Z-2379-2015 | Class II | AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized... | Boston Scientific Corporation | DXE | |
| Z-2378-2015 | Class II | AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681... | Boston Scientific Corporation | DXE | |
| Z-2377-2015 | Class II | AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553... | Boston Scientific Corporation | DXE | |
| Z-2444-2015 | Class II | Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product Usage... | Medtronic, Inc. | MPO | |
| Z-2443-2015 | Class II | Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage: Intended... | Medtronic, Inc. | MPO | |
| Z-2310-2016 | Class II | AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated, clinical... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-2309-2016 | Class II | AU680 Chemistry Analyzers, Reference No. B04779 The AU series are automated, clinical... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-2308-2016 | Class II | AU480 Chemistry Analyzers, Reference No. B28624 The AU series are automated, clinical... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-2770-2015 | Class II | Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue... | Lumenis Ltd | GCJ | |
| Z-2489-2015 | Class II | Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component... | Arrow International LLC (subsidiary of Teleflex Incorporated) | OBJ | |
| Z-2462-2015 | Class II | PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1864-2017 | Class II | Software version 4.44A utilized on the BD MAX System | BD Life Sciences | NSX | |
| Z-2767-2015 | Class II | NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system... | Nico Corporation | GEY | |
| Z-2760-2015 | Class II | UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant... | ZimVie US Corp LLC | NHA | |
| Z-2523-2015 | Class II | KimVent* Wet Pak* Closed Suction System for Pediatrics, 10 F, Y Adapter (Product Code... | Halyard Health | BSY | |
| Z-2522-2015 | Class II | KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product Code 206)... | Halyard Health | BSY | |
| Z-2521-2015 | Class II | KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Manifold (Product Code... | Halyard Health | BSY | |
| Z-2520-2015 | Class II | KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Y-Adapter (Product Code... | Halyard Health | BSY | |
| Z-2519-2015 | Class II | KimVent* Multi-Access Port Replacement Catheter for Adults, Endotracheal,16 F (Product... | Halyard Health | BSY | |
| Z-2518-2015 | Class II | KimVent* Multi-Access Port Closed Suction System for Adults,Tracheostomy, DSY, MDI, 14 F... | Halyard Health | BSY | |
| Z-2517-2015 | Class II | KimVent* Multi-Access Port Replacement Catheter for Adults,Tracheostomy, 14 F (Product... | Halyard Health | BSY | |
| Z-2516-2015 | Class II | KimVent* Multi-Access Port Closed Suction System for Adults, Endotracheal, DSY, 14 F... | Halyard Health | BSY | |
| Z-2515-2015 | Class II | KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI (Product Code... | Halyard Health | BSY | |
| Z-2514-2015 | Class II | KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Product Code... | Halyard Health | BSY | |
| Z-2513-2015 | Class II | KimVent* Closed Suction Systems for Adults, 14 F, Qwik Clip (Product Code 2273) A... | Halyard Health | BSY | |
| Z-2512-2015 | Class II | KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE (Product Code 227)... | Halyard Health | BSY | |
| Z-2511-2015 | Class II | NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, 14F (Product... | Halyard Health | BSY | |
| Z-2510-2015 | Class II | NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, Directional... | Halyard Health | BSY | |
| Z-2509-2015 | Class II | KimVent* Closed Suction System for Adults, 14 F, DSE, DT (Product Code 22109) A... | Halyard Health | BSY | |
| Z-2508-2015 | Class II | KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 22108); KimVent*... | Halyard Health | BSY | |
| Z-2507-2015 | Class II | KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8224)... | Halyard Health | BSY | |
| Z-2506-2015 | Class II | KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 2210); KimVent* Closed... | Halyard Health | BSY | |
| Z-2505-2015 | Class II | KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code 2276)... | Halyard Health | BSY | |
| Z-2504-2015 | Class II | KimVent* Closed Suction System for Adults, 14 F, Elbow, D-Tip (Product Code 2219) A... | Halyard Health | BSY | |
| Z-2503-2015 | Class II | KimVent* Closed Suction System for Adults, 12 F, Elbow (Product Code 216); KimVent*... | Halyard Health | BSY | |
| Z-2502-2015 | Class II | NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, Directional Tip, 14F... | Halyard Health | BSY | |
| Z-2501-2015 | Class II | NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece MDI Adapter, 14F... | Halyard Health | BSY | |
| Z-2500-2015 | Class II | NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, 14F (Product Code... | Halyard Health | BSY | |
| Z-2499-2015 | Class II | KimVent* Closed Suction System for Adults, 14 F, MDI, T-Piece, 12 in Tracheostomy... | Halyard Health | BSY | |
| Z-2498-2015 | Class II | KimVent* Turbo-Cleaning Closed Suction System for Adults, 10 F, T-Piece (Product Code... | Halyard Health | BSY | |
| Z-2497-2015 | Class II | KimVent* Closed Suction System for Adults, 12 F, T-Piece,12 in Tracheostomy (Product Code... | Halyard Health | BSY | |
| Z-2496-2015 | Class II | KimVent* Closed Suction System for Adults, 14 F, D-Tip, T-Piece (Product Code 22059)... | Halyard Health | BSY | |
| Z-2495-2015 | Class II | KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Code 22056)... | Halyard Health | BSY | |
| Z-2494-2015 | Class II | KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DT, T-Piece (Product Code... | Halyard Health | BSY | |
| Z-2493-2015 | Class II | KimVent* Closed Suction System for Adults, 14 F, T-Piece, MDI (Product Code 8308) A... | Halyard Health | BSY | |
| Z-2492-2015 | Class II | KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155); KimVent*... | Halyard Health | BSY | |
| Z-2451-2015 | Class II | Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large)... | Synthes (USA) Products LLC | KTT | |
| Z-2418-2015 | Class II | Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve... | Synthes (USA) Products LLC | GAD | |
| Z-2488-2015 | Class II | VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal... | Synthes (USA) Products LLC | MDI |