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-3000-2018 | Class I | OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099... | Ventana Medical Systems Inc | NJT | |
| Z-2999-2018 | Class I | ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098... | Ventana Medical Systems Inc | NJT | |
| Z-2998-2018 | Class I | iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry... | Ventana Medical Systems Inc | NJT | |
| Z-2997-2018 | Class I | ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500... | Ventana Medical Systems Inc | NJT | |
| Z-2996-2018 | Class I | OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700... | Ventana Medical Systems Inc | NJT | |
| Z-1821-2020 | Class II | Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50... | Allied Vision Group Inc | LPM | |
| Z-0171-2020 | Class II | Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010... | Abbott Medical | FRN | |
| Z-3188-2018 | Class II | sterEOS workstation | EOS imaging | LLZ | |
| Z-0077-2019 | Class II | Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL... | Instrumentation Laboratory Co. | GJS | |
| Z-0018-2019 | Class II | Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product... | Medtronic, Inc. | NAD | |
| Z-0017-2019 | Class II | Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product... | Medtronic, Inc. | NAD | |
| Z-0016-2019 | Class II | Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF... | Medtronic, Inc. | NAD | |
| Z-0015-2019 | Class II | Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF... | Medtronic, Inc. | NAD | |
| Z-0014-2019 | Class II | Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF... | Medtronic, Inc. | NAD | |
| Z-0013-2019 | Class II | Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF... | Medtronic, Inc. | NAD | |
| Z-2991-2018 | Class II | AIRO Mobile CT System Model # MobiCT-32 | Brainlab, Inc. | JAK | |
| Z-0009-2019 | Class I | ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb... | Endologix LLC | MIH | |
| Z-0008-2019 | Class I | ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO... | Endologix LLC | MIH | |
| Z-0007-2019 | Class I | ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF... | Endologix LLC | MIH | |
| Z-0056-2019 | Class II | Capnostream 20P (Intl) N W/printer - Rohs, Cs051cov-03 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0055-2019 | Class II | Capnostream 20P (Cov-Intl) N W/printer Rohs, Cs051cov | Oridion Medical 1987 Ltd. | DQA | |
| Z-0054-2019 | Class II | Capnostream20 (INTL) M W/PRINTER REFURBISHED, CS78660 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0053-2019 | Class II | Capnostream20 (INTL) N W/PRINTER REFURBISHED, CS78658 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0052-2019 | Class II | Capnostream20 (INTL) M REFURBISHED, CS78654 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0051-2019 | Class II | Capnostream20 (INTL) N REFURBISHED, CS78652 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0050-2019 | Class II | Capnostream20 N CYVITAL, CS08799 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0049-2019 | Class II | Capnostream20 N W/PRINTER CYVITAL, CS08798 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0048-2019 | Class II | Capnostream20 M W/PRINTER CYVITAL, CS08796 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0047-2019 | Class II | Capnostream20 (INTL) M W/PRINTER, CS08660 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0046-2019 | Class II | Capnostream20 M NICU (CPM), CS08654RN | Oridion Medical 1987 Ltd. | DQA | |
| Z-0045-2019 | Class II | Capnostream20 M ADULT ICU (CPM), CS08654RA | Oridion Medical 1987 Ltd. | DQA | |
| Z-0044-2019 | Class II | Capnostream20 (INTL) M, CS08654 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0043-2019 | Class II | Capnostream 20P (Intl) N W/printer - Rohs, Cs08658-03 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0042-2019 | Class II | Capnostream 20P (Intl) N W/printer - Rohs, Cs08658-02 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0041-2019 | Class II | CAPNOSTREAM 20P (INTL) N W/PRINTER, Part Number CS08658-01 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0040-2019 | Class II | CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0039-2019 | Class II | CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-03 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0038-2019 | Class II | CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-02 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0037-2019 | Class II | CAPNOSTREAM 20P (INTL) N, Part Number CS08652-01 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0036-2019 | Class II | CAPNOSTREAM 20 (INTL) N, Part Number CS08652 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0035-2019 | Class II | Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0034-2019 | Class II | Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0033-2019 | Class II | Capnostream20 (US)M REFURBISHED, Part Number CS78653 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0032-2019 | Class II | Capnostream20 (US) N REFURBISHED, Part Number CS78651 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0031-2019 | Class II | Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0030-2019 | Class II | Capnostream20 (US) M TO MASIMO, Part Number CS08750 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0029-2019 | Class II | Capnostream20 (US) M W/PRINTER, Part Number CS08659 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0028-2019 | Class II | Capnostream20 (US) M, Part Number CS08653 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0027-2019 | Class II | CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03 | Oridion Medical 1987 Ltd. | CCK | |
| Z-0026-2019 | Class II | CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01 | Oridion Medical 1987 Ltd. | CCK |