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-1702-2021 | Class II | ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures. | Zavation | NDN | |
| Z-1701-2021 | Class II | 10 GAUGE CEMENT DELIVERY CANNULA, INTVM-CDC. For use in Orthopedic / spinal procedures. | Zavation | NDN | |
| Z-1651-2021 | Class I | Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the... | The Biomed Guys | FRN | |
| Z-1535-2021 | Class II | Intellis Model 97755 Recharger - Product Usage: designed to charge the following... | Medtronic Neuromodulation | LGW | |
| Z-1427-2021 | Class II | RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-1700-2021 | Class II | 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in... | Zavation | NDN | |
| Z-1552-2021 | Class II | PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended... | Bard Peripheral Vascular Inc | LJT | |
| Z-1551-2021 | Class II | PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended... | Bard Peripheral Vascular Inc | LJT | |
| Z-1550-2021 | Class II | PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended... | Bard Peripheral Vascular Inc | LJT | |
| Z-1414-2021 | Class II | cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number... | Roche Molecular Systems Inc | QJR | |
| Z-1413-2021 | Class II | cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus... | Roche Molecular Systems Inc | QJR | |
| Z-1353-2021 | Class II | Drop Arm Versamode" | GF Health Products, Inc. | ILS | |
| Z-1416-2021 | Class II | BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative... | Becton Dickinson & Co | QJR | |
| Z-1375-2021 | Class I | Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific... | Pacific Medical Group Inc. | FRN | |
| Z-1624-2021 | Class II | Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF... | Bioseal | KDD | |
| Z-1623-2021 | Class II | Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF... | Bioseal | KDD | |
| Z-1622-2021 | Class II | Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF... | Bioseal | KDD | |
| Z-1564-2021 | Class III | VenaSeal Closure System | Medtronic, Inc. | PJQ | |
| Z-1419-2021 | Class II | Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with... | Medtronic, Inc. | GDW | |
| Z-1382-2021 | Class II | SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA | Sunstar Americas, Inc. | EAX | |
| Z-1326-2021 | Class II | Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring... | Philips North America LLC | MHX | |
| Z-2277-2021 | Class II | Spectrum Medical Quantum Standard heat exchanger | Spectrum Medical Inc | KFM | |
| Z-1649-2021 | Class II | 10 Gauge Drill, Code Intvm-Drl | Biopsybell S.r.l. | LOD | |
| Z-1648-2021 | Class II | 10G Coaxial Cannula with Tuohy Connection, Code Intvm-Cc | Biopsybell S.r.l. | LOD | |
| Z-1647-2021 | Class II | 10G Direct Working Cannula Bevel Tip 15Cm, Code Intvm-Dwcb/15 | Biopsybell S.r.l. | LOD | |
| Z-1646-2021 | Class II | 10 Gauge Single Cement Delivery 4 Fillers 4 Syringes, Code Intvm-Scdk | Biopsybell S.r.l. | LOD | |
| Z-1645-2021 | Class II | 8G Direct Working Cannula Bevel Tip, Code Intv-Dwcb | Biopsybell S.r.l. | LOD | |
| Z-1831-2021 | Class II | Normand Remisol Advance Data Manager is a software device that interfaces between... | Normand-Info S.A.S.U. | JQP | |
| Z-1644-2021 | Class II | 11G Direct Single - Access, Code Intvmn-Dsbak | Biopsybell S.r.l. | LOD | |
| Z-1643-2021 | Class II | 11G Direct Working Cannula Diamond Tip Mini, Code Intvmn-Dwcd | Biopsybell S.r.l. | LOD | |
| Z-1642-2021 | Class II | Cemix - Cement Mixing System, Code Intv-Mms | Biopsybell S.r.l. | LOD | |
| Z-1641-2021 | Class II | 11G Direct Single - Delivery (4 Fillers-4 Syringes), Code Intvmn-Scdk | Biopsybell S.r.l. | LOD | |
| Z-1640-2021 | Class II | 8G Direct Working Cannula Bevel Tip, Code Intvm-Dwcb | Biopsybell S.r.l. | LOD | |
| Z-1639-2021 | Class II | 10G Direct Single - Access, Code Intvm-Dsbak | Biopsybell S.r.l. | LOD | |
| Z-1638-2021 | Class II | 10 Gauge Cement Delivery Cannula, Code Intvm-Cdc | Biopsybell S.r.l. | LOD | |
| Z-1637-2021 | Class II | 10 Gauge Direct Unilateral Stylet(1 X Diamond 1 X Bevel), Code Intvm-Dsskbd | Biopsybell S.r.l. | LOD | |
| Z-1636-2021 | Class II | EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS | Biopsybell S.r.l. | LOD | |
| Z-1635-2021 | Class II | Cement Mixing System, Vertebroplasty-Kyphoplasty, Ref Vcf-1051 | Biopsybell S.r.l. | LOD | |
| Z-1634-2021 | Class II | BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111 | Biopsybell S.r.l. | KNW | |
| Z-1633-2021 | Class II | BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES... | Biopsybell S.r.l. | LOD | |
| Z-1632-2021 | Class II | Renova Spine Bone Filler 10G 12Cm Centim. Sterile, Resfil1112c1-US | Biopsybell S.r.l. | LOD | |
| Z-1631-2021 | Class II | BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system | Biopsybell S.r.l. | LOD | |
| Z-1507-2021 | Class III | Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic... | Datascope Corp. | DSP | |
| Z-1506-2021 | Class III | Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic... | Datascope Corp. | DSP | |
| Z-2516-2021 | Class II | Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set... | Aesculap Inc | HRY | |
| Z-2515-2021 | Class II | Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS... | Aesculap Inc | HRY | |
| Z-2514-2021 | Class II | Univation X System knee implant devices as follows: Catalog/Product: NO156Z AS... | Aesculap Inc | HRY | |
| Z-2513-2021 | Class II | Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F... | Aesculap Inc | HRY | |
| Z-2512-2021 | Class II | Univation X System knee implant devices as follows: Catalog/Product: NL488 UNIVATION F... | Aesculap Inc | HRY | |
| Z-2511-2021 | Class II | Univation X System knee implant devices as follows: Catalog/Product: NL482 UNIVATION F... | Aesculap Inc | HRY |