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-2039-2021 | Class II | FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI... | BioFire Diagnostics, LLC | QBH | |
| Z-1926-2021 | Class II | reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of... | Pear Therapeutics, Inc. | PWE | |
| Z-1925-2021 | Class II | reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of... | Pear Therapeutics, Inc. | PWE | |
| Z-2254-2021 | Class II | Simpleware ScanIP medical software. For transfer of imaging information from a medical... | Simpleware Product Group, SYNOPSYS NORTHERN EUROPE | LLZ | |
| Z-2253-2021 | Class II | Simpleware ScanIP software. For transfer of imaging information from a medical scanner to... | Simpleware Product Group, SYNOPSYS NORTHERN EUROPE | LLZ | |
| Z-2065-2021 | Class II | 1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System | GE Healthcare | LNH | |
| Z-2064-2021 | Class II | Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System | GE Healthcare | LNH | |
| Z-2063-2021 | Class II | Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System | GE Healthcare | LNH | |
| Z-2062-2021 | Class II | SIGNA Voyager, Nuclear Magnetic Resonance Imaging System | GE Healthcare | LNH | |
| Z-2061-2021 | Class II | SIGNA Artist, Nuclear Magnetic Resonance Imaging System | GE Healthcare | LNH | |
| Z-2060-2021 | Class II | SIGNA MR380, Nuclear Magnetic Resonance Imaging System | GE Healthcare | LNH | |
| Z-2059-2021 | Class II | SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System | GE Healthcare | LNH | |
| Z-2058-2021 | Class II | SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System | GE Healthcare | LNH | |
| Z-2057-2021 | Class II | SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear... | GE Healthcare | OUO | |
| Z-2056-2021 | Class II | Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed... | GE Healthcare | LNH | |
| Z-2055-2021 | Class II | Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner... | GE Healthcare | LNH | |
| Z-2054-2021 | Class II | SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to... | GE Healthcare | LNH | |
| Z-2053-2021 | Class II | SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to... | GE Healthcare | LNH | |
| Z-2052-2021 | Class II | SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to... | GE Healthcare | LNH | |
| Z-2110-2021 | Class I | Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the... | Baxter Healthcare Corporation | FRN | |
| Z-2005-2021 | Class I | Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN... | Eight Medical International BV | LGZ | |
| Z-2326-2021 | Class II | ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of... | Ethicon Endo-Surgery Inc | GDW | |
| Z-2197-2021 | Class I | HeartWare HVAD Pump Accessories, REF MCS1753AK | HeartWare, Inc. | DSQ | |
| Z-2196-2021 | Class I | HeartWare HVAD Outflow Graft, REF MCS1725OG | HeartWare, Inc. | DSQ | |
| Z-2195-2021 | Class I | HeartWare HVAD Implant Kit, REF MCS1705PU | HeartWare, Inc. | DSQ | |
| Z-2194-2021 | Class I | HeartWare HVAD Implant Kit, REF 1104JP | HeartWare, Inc. | DSQ | |
| Z-2193-2021 | Class I | HeartWare HVAD Driveline Extension Cable, REF 100US | HeartWare, Inc. | DSQ | |
| Z-2192-2021 | Class I | HeartWare HVAD Driveline Extension Cable, REF 100 | HeartWare, Inc. | DSQ | |
| Z-2191-2021 | Class I | HeartWare HVAD Pump Implant Kit, REF 1153 | HeartWare, Inc. | DSQ | |
| Z-2190-2021 | Class I | HeartWare HVAD Pump Implant Kit, REF 1125 | HeartWare, Inc. | DSQ | |
| Z-2189-2021 | Class I | HeartWare HVAD Pump Implant Kit, REF 1104 | HeartWare, Inc. | DSQ | |
| Z-2188-2021 | Class I | HeartWare HVAD Pump Implant Kit, REF 1103 | HeartWare, Inc. | DSQ | |
| Z-2077-2021 | Class II | BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid... | Axonics, Inc. | LNM | |
| Z-2020-2021 | Class I | INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021) | Boston Scientific Corporation | NKE | |
| Z-2019-2021 | Class I | INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273 | Boston Scientific Corporation | NKE | |
| Z-2018-2021 | Class I | INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173 | Boston Scientific Corporation | NKE | |
| Z-2017-2021 | Class I | VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d)... | Boston Scientific Corporation | LWP | |
| Z-2016-2021 | Class I | INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d)... | Boston Scientific Corporation | LWP | |
| Z-2015-2021 | Class I | ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d)... | Boston Scientific Corporation | LWP | |
| Z-2003-2021 | Class II | VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228 | Boston Scientific Corporation | NKE | |
| Z-2002-2021 | Class II | VALITUDE CRT-P pacemaker, Models: a) U125 b) U128 | Boston Scientific Corporation | NKE | |
| Z-2001-2021 | Class II | Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722 | Boston Scientific Corporation | LWP | |
| Z-2000-2021 | Class II | Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331 | Boston Scientific Corporation | LWP | |
| Z-1999-2021 | Class II | Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231 | Boston Scientific Corporation | LWP | |
| Z-1998-2021 | Class II | Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131 | Boston Scientific Corporation | LWP | |
| Z-2275-2021 | Class II | Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM Item Number... | Zimmer GmbH | KWA | |
| Z-2274-2021 | Class II | Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number... | Zimmer GmbH | KWA | |
| Z-2273-2021 | Class II | Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM Item Number... | Zimmer GmbH | KWA | |
| Z-2272-2021 | Class II | Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Item... | Zimmer GmbH | KWA | |
| Z-2271-2021 | Class II | Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM Item Number... | Zimmer GmbH | KWA |