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-1405-2023 | Class II | MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device | Medacta USA, Inc. | OVD | |
| Z-1404-2023 | Class II | MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device | Medacta USA, Inc. | OVD | |
| Z-1403-2023 | Class II | MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device | Medacta USA, Inc. | OVD | |
| Z-1402-2023 | Class II | MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device | Medacta USA, Inc. | OVD | |
| Z-1401-2023 | Class II | MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device | Medacta USA, Inc. | OVD | |
| Z-1400-2023 | Class II | MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device | Medacta USA, Inc. | OVD | |
| Z-1394-2023 | Class II | AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is... | Radiometer Medical ApS | OUG | |
| Z-1392-2023 | Class II | FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30... | BioFire Diagnostics, LLC | PCH | |
| Z-1398-2023 | Class II | REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to... | Compass Health Brands (Corporate Office) | IRP | |
| Z-1645-2023 | Class II | EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number... | Philips North America LLC | DSJ | |
| Z-1644-2023 | Class II | EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number... | Philips North America LLC | DSJ | |
| Z-1337-2023 | Class II | VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W | Maquet Cardiovascular LLC | GEI | |
| Z-1336-2023 | Class II | VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000 | Maquet Cardiovascular LLC | GEI | |
| Z-1335-2023 | Class II | VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500 | Maquet Cardiovascular LLC | GEI | |
| Z-1589-2023 | Class II | CombiDiagnost R90 R1.1 | Philips North America LLC | JAA | |
| Z-1588-2023 | Class II | CombiDiagnost R90 R.1.0 | Philips North America LLC | JAA | |
| Z-1587-2023 | Class II | ProxiDiagnost N90 R.1.0 | Philips North America LLC | JAA | |
| Z-1605-2023 | Class II | HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004 | Access Vascular, Inc | LJS | |
| Z-1381-2023 | Class II | NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation... | Boston Scientific Corporation | OAB | |
| Z-1407-2023 | Class II | Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile. | MEDLINE INDUSTRIES, LP - Northfield | HFX | |
| Z-1474-2023 | Class II | SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT... | Stryker Corp. | FCW | |
| Z-1292-2023 | Class II | Cirq Arm System 2.0 | Brainlab, Inc. | OLO | |
| Z-1390-2023 | Class II | Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD... | Medtronic, Inc. | GAL | |
| Z-1389-2023 | Class II | Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT... | Medtronic, Inc. | GAL | |
| Z-1388-2023 | Class II | Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR... | Medtronic, Inc. | GAL | |
| Z-1387-2023 | Class II | Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5... | Medtronic, Inc. | GCJ | |
| Z-1353-2023 | Class II | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and... | Shanghai United Imaging Healthcare Co., Ltd. | KPS | |
| Z-1344-2023 | Class II | Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT... | Stryker Corp. | KCY | |
| Z-1343-2023 | Class II | Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT... | Stryker Corp. | KCY | |
| Z-1342-2023 | Class II | Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT... | Stryker Corp. | KCY | |
| Z-1341-2023 | Class II | Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT... | Stryker Corp. | KCY | |
| Z-1340-2023 | Class II | Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT... | Stryker Corp. | KCY | |
| Z-1339-2023 | Class II | Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT... | Stryker Corp. | KCY | |
| Z-1315-2023 | Class II | Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF... | Stryker Sustainability Solutions | KCY | |
| Z-1289-2023 | Class I | Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B | Respironics, Inc. | CBK | |
| Z-1288-2023 | Class I | Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B... | Respironics, Inc. | CBK | |
| Z-1287-2023 | Class I | Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B... | Respironics, Inc. | CBK | |
| Z-1375-2023 | Class II | Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis | MEDLINE INDUSTRIES, LP - Northfield | FHW | |
| Z-1374-2023 | Class II | Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis | MEDLINE INDUSTRIES, LP - Northfield | FHW | |
| Z-1373-2023 | Class II | Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis | MEDLINE INDUSTRIES, LP - Northfield | FHW | |
| Z-1372-2023 | Class II | Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis | MEDLINE INDUSTRIES, LP - Northfield | FHW | |
| Z-1371-2023 | Class II | Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis | MEDLINE INDUSTRIES, LP - Northfield | FHW | |
| Z-1370-2023 | Class II | Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis | MEDLINE INDUSTRIES, LP - Northfield | FHW | |
| Z-1369-2023 | Class II | Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis | MEDLINE INDUSTRIES, LP - Northfield | FHW | |
| Z-1368-2023 | Class II | Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis | MEDLINE INDUSTRIES, LP - Northfield | FHW | |
| Z-1367-2023 | Class II | Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis | MEDLINE INDUSTRIES, LP - Northfield | FHW | |
| Z-1366-2023 | Class II | Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis | MEDLINE INDUSTRIES, LP - Northfield | FHW | |
| Z-1365-2023 | Class II | Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis | MEDLINE INDUSTRIES, LP - Northfield | FHW | |
| Z-1364-2023 | Class II | Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis | MEDLINE INDUSTRIES, LP - Northfield | FHW | |
| Z-1363-2023 | Class II | Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis | MEDLINE INDUSTRIES, LP - Northfield | FHW |