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-1362-2023 | Class II | Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis | MEDLINE INDUSTRIES, LP - Northfield | FHW | |
| Z-1361-2023 | Class II | Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis | MEDLINE INDUSTRIES, LP - Northfield | FHW | |
| Z-1360-2023 | Class II | Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis | MEDLINE INDUSTRIES, LP - Northfield | FHW | |
| Z-1359-2023 | Class II | Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis | MEDLINE INDUSTRIES, LP - Northfield | FHW | |
| Z-1309-2023 | Class II | Instructions for Use for the following Leksell Stereotactic System and Leksell... | Elekta Instrument AB | HAW | |
| Z-1347-2023 | Class II | CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC | Terumo Cardiovascular Systems Corporation | DTZ | |
| Z-1346-2023 | Class II | CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE | Terumo Cardiovascular Systems Corporation | DTZ | |
| Z-1345-2023 | Class II | CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30 | Terumo Cardiovascular Systems Corporation | DTZ | |
| Z-1303-2023 | Class II | Express Mini 500 Dry Seal Chest Drain, Part Number 16400 | Atrium Medical Corporation | KDQ | |
| Z-1302-2023 | Class II | Atrium Pneumostat Chest Drain Valve, Part Number 16100 | Atrium Medical Corporation | KDQ | |
| Z-0156-2024 | Class II | Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085 | Omega Medical Imaging, LLC | IWE | |
| Z-2618-2023 | Class II | Omnipod 5 Automated Insulin Delivery System | Insulet Corporation | QFG | |
| Z-1384-2023 | Class II | EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF... | Encore Medical, LP | MBH | |
| Z-1572-2023 | Class II | BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack | Bio-Rad Laboratories Inc. | MID | |
| Z-1233-2023 | Class II | Monaco RTP System. Used to make treatment plans for patients with prescriptions for... | Elekta Limited | MUJ | |
| Z-1279-2023 | Class II | Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model... | Datascope Corp. | DSP | |
| Z-1278-2023 | Class II | Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140 | Datascope Corp. | DSP | |
| Z-1277-2023 | Class II | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers... | Datascope Corp. | DSP | |
| Z-1276-2023 | Class II | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31... | Datascope Corp. | DSP | |
| Z-1260-2023 | Class II | Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM... | Bard Peripheral Vascular Inc | KNW | |
| Z-2044-2023 | Class II | RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain... | Appliedvr | QRA | |
| Z-1470-2023 | Class II | FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in... | FUJIFILM Healthcare Americas Corporation | IZL | |
| Z-1294-2023 | Class II | CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component... | Zimmer GmbH | LPH | |
| Z-1399-2023 | Class II | Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for... | Tobii Dynavox LLC | ILQ | |
| Z-1310-2023 | Class II | Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe... | Iradimed Corporation | FRN | |
| Z-1430-2023 | Class II | Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical... | Aesculap Inc | FSM | |
| Z-1418-2023 | Class II | Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8... | OLYMPUS Corporation of the Americas | MND | |
| Z-1321-2023 | Class II | Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by... | Remote Diagnostic Technologies Ltd. | MHX | |
| Z-1316-2023 | Class II | Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution... | Baxter Healthcare Corporation | FKX | |
| Z-1285-2023 | Class II | Neodent GM X 6mm Engaging Titanium Base, REF: 9007162 | PREAT Corporation | NHA | |
| Z-1317-2023 | Class II | SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210 | Limacorporate S.p.A. | MBF | |
| Z-1378-2023 | Class II | BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD | Bio-Rad Laboratories Inc. | NHX | |
| Z-1377-2023 | Class II | BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD | Bio-Rad Laboratories Inc. | NHX | |
| Z-1320-2023 | Class II | Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF... | Biosense Webster Inc | DYB | |
| Z-1319-2023 | Class II | Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF... | Biosense Webster Inc | DYB | |
| Z-1301-2023 | Class II | PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003... | Entopsis, Inc. | JJH | |
| Z-1300-2023 | Class II | PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL... | Entopsis, Inc. | JJH | |
| Z-1299-2023 | Class II | PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b)... | Entopsis, Inc. | JJH | |
| Z-1298-2023 | Class II | PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50... | Entopsis, Inc. | JJH | |
| Z-1297-2023 | Class II | PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction... | Entopsis, Inc. | JJH | |
| Z-1296-2023 | Class II | PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no... | Entopsis, Inc. | JJH | |
| Z-1295-2023 | Class II | PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological... | Entopsis, Inc. | JJH | |
| Z-1468-2023 | Class II | Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box... | Mani, Inc. (Head Office) | NGY | |
| Z-1417-2023 | Class II | 2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1 | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1416-2023 | Class II | SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6 | Philips Medical Systems Nederland B.V. | OWB | |
| Z-1338-2023 | Class II | Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term... | Moberg Research, Inc. | OMA | |
| Z-1629-2023 | Class II | Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in... | Arjohuntleigh Magog, Inc. | FSA | |
| Z-1281-2023 | Class II | Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-1358-2023 | Class III | Agilent Resolution ctDx FIRST Sample Collection Kit, 500032 | Agilent Technologies Inc./US | PQP | |
| Z-1354-2023 | Class II | thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF... | Solta Medical, Inc. | GEI |