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-0775-2022 | Class II | JAGTOME RX 44-30-260-035 Material Number: M00573060 | Boston Scientific Corporation | KNS | |
| Z-0774-2022 | Class II | JAGTOME RX 44-20-450-035 Material Number: M00573050 | Boston Scientific Corporation | KNS | |
| Z-0773-2022 | Class II | JAGTOME RX 44-20-260-035 Material Number: M00573040 | Boston Scientific Corporation | KNS | |
| Z-0772-2022 | Class II | JAGTOME RX 39-30-450-025 Material Number: M00573110 | Boston Scientific Corporation | KNS | |
| Z-0771-2022 | Class II | JAGTOME RX 39-30-260-025 Material Number: M00573100 | Boston Scientific Corporation | KNS | |
| Z-0770-2022 | Class II | JAGTOME RX 39-30-260-025 Material Number: M00573100 | Boston Scientific Corporation | KNS | |
| Z-0769-2022 | Class II | JAGTOME RX 39-20-450-025 Material Number: M00573090 | Boston Scientific Corporation | KNS | |
| Z-0768-2022 | Class II | JAGTOME RX 39-20-260-025 Material Number: M00573080 | Boston Scientific Corporation | KNS | |
| Z-0767-2022 | Class II | JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260 | Boston Scientific Corporation | KNS | |
| Z-0766-2022 | Class II | JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250 | Boston Scientific Corporation | KNS | |
| Z-0765-2022 | Class II | JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240 | Boston Scientific Corporation | KNS | |
| Z-0764-2022 | Class II | HYDRATOME RX 49-30MM/260CM Material Number: M00583010 | Boston Scientific Corporation | KNS | |
| Z-0763-2022 | Class II | HYDRATOME RX 49-20MM/260CM Material Number: M00583000 | Boston Scientific Corporation | KNS | |
| Z-0762-2022 | Class II | HYDRATOME RX 44-30MM/450CM Material Number: M00583070 | Boston Scientific Corporation | KNS | |
| Z-0761-2022 | Class II | HYDRATOME RX 44-30MM/260CM Material Number: M00583050 | Boston Scientific Corporation | KNS | |
| Z-0760-2022 | Class II | HYDRATOME RX 44-20MM/450CM Material Number: M00583060 | Boston Scientific Corporation | KNS | |
| Z-0759-2022 | Class II | HYDRATOME RX 44-20MM/260CM Material Number: M00583040 | Boston Scientific Corporation | KNS | |
| Z-0758-2022 | Class II | DREAMTOME 49-30MM/450CM Material Number: M00584030 | Boston Scientific Corporation | KNS | |
| Z-0757-2022 | Class II | DREAMTOME 49-30MM/260CM Material Number: M00584010 | Boston Scientific Corporation | KNS | |
| Z-0756-2022 | Class II | DREAMTOME 49-20MM/450CM Material Number: M00584020 | Boston Scientific Corporation | KNS | |
| Z-0755-2022 | Class II | DREAMTOME 49-20MM/260CM Material Number: M00584000 | Boston Scientific Corporation | KNS | |
| Z-0754-2022 | Class II | DREAMTOME 44-30MM/450CM Material Number: M00584070 | Boston Scientific Corporation | KNS | |
| Z-0753-2022 | Class II | DREAMTOME 44-30MM/260CM Material Number: M00584050 | Boston Scientific Corporation | KNS | |
| Z-0752-2022 | Class II | Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060 | Boston Scientific Corporation | KNS | |
| Z-0751-2022 | Class II | Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number... | Boston Scientific Corporation | KNS | |
| Z-0634-2022 | Class II | Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative... | Synthes (USA) Products LLC | LXH | |
| Z-0646-2022 | Class II | Destino Twist 14F (also branded as Guidestar 14F) | Oscor Inc. | DYB | |
| Z-0481-2022 | Class I | ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60 | Empowered Diagnostics LLC | QKO | |
| Z-0531-2022 | Class II | 8mm FlexDex Needle Driver, Product Code FD-335 ND | FlexDex Inc. | MDM | |
| Z-0480-2022 | Class I | CovClear COVID-19 Rapid Antigen Test, ATG 900-031 | Empowered Diagnostics LLC | QKP | |
| Z-0566-2022 | Class II | MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL | Halyard Health | KNT | |
| Z-0565-2022 | Class II | MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL | Halyard Health | KNT | |
| Z-0514-2022 | Class II | SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001... | Medtronic, Inc. | OQU | |
| Z-0743-2022 | Class II | NIM TRIVANTAGE EMG Endotracheal Tube | Medtronic Xomed, Inc. | ETN | |
| Z-0494-2022 | Class I | Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The... | Respironics, Inc. | CBK | |
| Z-0493-2022 | Class I | Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo... | Respironics, Inc. | CBK | |
| Z-0896-2022 | Class II | C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or... | DRG International, Inc. | JKD | |
| Z-0645-2022 | Class II | Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110 | Howmedica Osteonics Corp | KTT | |
| Z-0644-2022 | Class II | 32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032 | Howmedica Osteonics Corp | LPH | |
| Z-0657-2022 | Class II | Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent... | Medtronic, Inc. | MIH | |
| Z-0622-2022 | Class I | bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator... | Jaeger Medical GmbH | CBK | |
| Z-0525-2022 | Class II | API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative... | bioMerieux, Inc. | JXB | |
| Z-0492-2022 | Class II | Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item... | Canon Medical Systems USA, Inc. | OWB | |
| Z-0658-2022 | Class II | NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R | Nobel Biocare USA LLC | DZE | |
| Z-0557-2022 | Class II | Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with... | Medtronic, Inc. | LIT | |
| Z-0787-2022 | Class III | Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI... | LivaNova Deutschland GmbH | DWA | |
| Z-0655-2022 | Class II | Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40 | Shimadzu Medical Systems | OWB | |
| Z-0654-2022 | Class II | Digital Angiography System Bransist safire Generator Model D150GC-40 | Shimadzu Medical Systems | IZI | |
| Z-0501-2022 | Class II | Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300 | Draeger, Inc. | BSZ | |
| Z-0961-2022 | Class II | Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product... | Medtronic Xomed, Inc. | ERL |