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-0054-2022 | Class II | Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat... | ZOLL Circulation, Inc. | NCX | |
| Z-0053-2022 | Class II | Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit... | ZOLL Circulation, Inc. | NCX | |
| Z-0052-2022 | Class II | Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with... | ZOLL Circulation, Inc. | NCX | |
| Z-0051-2022 | Class II | Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Catheter Kit... | ZOLL Circulation, Inc. | NCX | |
| Z-0050-2022 | Class II | Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with... | ZOLL Circulation, Inc. | NCX | |
| Z-0049-2022 | Class II | Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with... | ZOLL Circulation, Inc. | NCX | |
| Z-0048-2022 | Class II | Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom... | ZOLL Circulation, Inc. | NCX | |
| Z-0047-2022 | Class II | Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with... | ZOLL Circulation, Inc. | NCX | |
| Z-0046-2022 | Class II | ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with... | ZOLL Circulation, Inc. | NCX | |
| Z-0045-2022 | Class II | ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit... | ZOLL Circulation, Inc. | NCX | |
| Z-0044-2022 | Class II | ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit... | ZOLL Circulation, Inc. | NCX | |
| Z-0043-2022 | Class II | ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with... | ZOLL Circulation, Inc. | NCX | |
| Z-0042-2022 | Class II | ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange... | ZOLL Circulation, Inc. | NCX | |
| Z-0041-2022 | Class II | ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit... | ZOLL Circulation, Inc. | NCX | |
| Z-0040-2022 | Class II | Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat... | ZOLL Circulation, Inc. | NCX | |
| Z-0039-2022 | Class II | Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with... | ZOLL Circulation, Inc. | NCX | |
| Z-0028-2022 | Class II | TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the... | Advanced Medical Optics, Inc. | MJP | |
| Z-2575-2021 | Class II | NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021... | MEDLINE INDUSTRIES, LP - Northfield | DTL | |
| Z-2478-2021 | Class II | Medtronic HVAD Pump Implant Kits | HeartWare, Inc. | DSQ | |
| Z-2484-2021 | Class II | Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and... | Philips North America LLC | IYO | |
| Z-2503-2021 | Class II | Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays... | GE Healthcare | LLZ | |
| Z-2502-2021 | Class II | Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays... | GE Healthcare | LLZ | |
| Z-0106-2022 | Class II | Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10... | Intuitive Surgical, Inc. | EOQ | |
| Z-2574-2021 | Class II | NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN... | MEDLINE INDUSTRIES, LP - Northfield | DTL | |
| Z-2483-2021 | Class II | EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ... | Philips North America LLC | IYO | |
| Z-2377-2021 | Class I | NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500... | Abbott Medical | LGZ | |
| Z-2376-2021 | Class I | NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 | Abbott Medical | LGZ | |
| Z-2508-2021 | Class II | Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF... | Siemens Healthcare Diagnostics Inc. | QKO | |
| Z-2541-2021 | Class II | Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock"... | C.R. Bard Inc | EZL | |
| Z-2540-2021 | Class II | Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete... | C.R. Bard Inc | EZL | |
| Z-2539-2021 | Class II | Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabilization... | C.R. Bard Inc | EZL | |
| Z-2538-2021 | Class II | Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete... | C.R. Bard Inc | MJC | |
| Z-2537-2021 | Class II | Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization... | C.R. Bard Inc | EZL | |
| Z-2536-2021 | Class II | Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization... | C.R. Bard Inc | EZC | |
| Z-2535-2021 | Class II | Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter | C.R. Bard Inc | EZC | |
| Z-2534-2021 | Class II | Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization... | C.R. Bard Inc | EZC | |
| Z-2533-2021 | Class II | Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization... | C.R. Bard Inc | GBM | |
| Z-2532-2021 | Class II | Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray | C.R. Bard Inc | EZC | |
| Z-2531-2021 | Class II | Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray | C.R. Bard Inc | EZC | |
| Z-2530-2021 | Class II | Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray | C.R. Bard Inc | EZC | |
| Z-2529-2021 | Class II | Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray | C.R. Bard Inc | EZC | |
| Z-2528-2021 | Class II | Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage Bag... | C.R. Bard Inc | N/A | |
| Z-2527-2021 | Class II | Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter... | C.R. Bard Inc | MJC | |
| Z-2526-2021 | Class II | Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter... | C.R. Bard Inc | MJC | |
| Z-2525-2021 | Class II | Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter... | C.R. Bard Inc | MJC | |
| Z-2524-2021 | Class II | Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag... | C.R. Bard Inc | MJC | |
| Z-2523-2021 | Class II | Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag... | C.R. Bard Inc | MJC | |
| Z-2522-2021 | Class II | Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag... | C.R. Bard Inc | MJC | |
| Z-2521-2021 | Class II | Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing... | C.R. Bard Inc | MJC | |
| Z-2433-2021 | Class I | AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes... | Armstrong Medical Ltd. | CBL |