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-1048-2017 | Class II | AFX Endovascular AAA System Item Number Item Description F0070305... | Endologix LLC | MIH | |
| Z-1421-2017 | Class II | IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number... | Siemens Healthcare Diagnostics Inc. | JLS | |
| Z-1420-2017 | Class II | IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number... | Siemens Healthcare Diagnostics Inc. | JLS | |
| Z-1419-2017 | Class II | Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number... | Siemens Healthcare Diagnostics Inc. | JLS | |
| Z-1418-2017 | Class II | ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product... | Siemens Healthcare Diagnostics Inc. | JLS | |
| Z-1095-2017 | Class II | Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system is intended to... | Baxter Healthcare Corporation | KDI | |
| Z-1094-2017 | Class II | Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system is intended to... | Baxter Healthcare Corporation | KDI | |
| Z-1115-2017 | Class II | Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number... | Zimmer GmbH | JWH | |
| Z-1198-2017 | Class II | Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex... | Allen Medical Systems, Inc. | HST | |
| Z-1150-2017 | Class II | 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set... | Stryker Leibinger GmbH & Co. KG | GCY | |
| Z-1149-2017 | Class II | QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm... | Stryker Leibinger GmbH & Co. KG | GCY | |
| Z-1294-2018 | Class II | Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat. | Seiler Instrument & Mfg. Co.,Inc. | EPT | |
| Z-2614-2017 | Class II | Standex International Bakers Pride Microwave Ovens Model E300 | Standex Intl Corp | RCR | |
| Z-2126-2017 | Class II | Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST... | bioMerieux, Inc. | JWY | |
| Z-1682-2017 | Class II | Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of... | Abbott Medical | FRN | |
| Z-1124-2017 | Class II | Synthes Radial Head Prosthesis System, Surgical instrument motors and... | Synthes (USA) Products LLC | KWI | |
| Z-0456-2019 | Class II | Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical... | American Contract Systems, Inc. | KGO | |
| Z-1136-2017 | Class II | Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm... | Medtronic Navigation, Inc | KNW | |
| Z-1135-2017 | Class II | Intact Disposable Wands (part of the Intact System) 777-120BT: 5 Pack 20mm... | Medtronic Navigation, Inc | KNW | |
| Z-1134-2017 | Class II | Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm... | Medtronic Navigation, Inc | KNW | |
| Z-1133-2017 | Class II | Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm... | Medtronic Navigation, Inc | KNW | |
| Z-1132-2017 | Class II | Intact Disposable Wands (part of the Intact System) 777-115BT: 5 Pack 15mm... | Medtronic Navigation, Inc | KNW | |
| Z-1131-2017 | Class II | Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm... | Medtronic Navigation, Inc | KNW | |
| Z-1130-2017 | Class II | Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm... | Medtronic Navigation, Inc | KNW | |
| Z-1129-2017 | Class II | Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm... | Medtronic Navigation, Inc | KNW | |
| Z-1128-2017 | Class II | Intact Disposable Wands (part of the Intact System) 777-112: 5 Pack 12mm... | Medtronic Navigation, Inc | KNW | |
| Z-1127-2017 | Class II | Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm... | Medtronic Navigation, Inc | KNW | |
| Z-1126-2017 | Class II | Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm... | Medtronic Navigation, Inc | KNW | |
| Z-1430-2017 | Class II | Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems... | Villa Sistemi Medicali S.p.A. | KXJ | |
| Z-1429-2017 | Class II | Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems... | Villa Sistemi Medicali S.p.A. | KXJ | |
| Z-1428-2017 | Class II | Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 97841202... | Villa Sistemi Medicali S.p.A. | KXJ | |
| Z-1427-2017 | Class II | Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of... | Villa Sistemi Medicali S.p.A. | KXJ | |
| Z-1109-2017 | Class II | Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003 | IMMY, Inc. | GMD | |
| Z-1039-2017 | Class II | AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and... | Endologix LLC | MIH | |
| Z-1047-2017 | Class II | AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA... | Endologix LLC | MIH | |
| Z-1038-2017 | Class II | AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is... | Endologix LLC | MIH | |
| Z-1054-2017 | Class II | AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and... | Endologix LLC | MIH | |
| Z-1037-2017 | Class II | AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and... | Endologix LLC | MIH | |
| Z-1106-2017 | Class II | Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue... | Philips North America LLC | OUG | |
| Z-1090-2017 | Class II | cobas p 612 pre-analytical system; Pre-analytical sample handling that includes... | Roche Diagnostics GmbH | JQP | |
| Z-1035-2017 | Class II | AFX Endovascular AAA System, Endoleak Type IIIA | Endologix LLC | MIH | |
| Z-1060-2017 | Class II | OEC 9900 Elite. MDL Numbers: D148942, D155043 | GE Healthcare | OWB | |
| Z-1059-2017 | Class II | OEC 9800. MDL Numbers: D222250, D141598 | GE Healthcare | OWB | |
| Z-1897-2017 | Class II | BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed... | Becton Dickinson & Co | FPA | |
| Z-1187-2017 | Class II | BrightView X upgraded to XCT 882454 | Philips North America LLC | KPS | |
| Z-1186-2017 | Class II | BrightView XCT | Philips North America LLC | KPS | |
| Z-1058-2017 | Class II | Brilliance iCT | Philips North America LLC | JAK | |
| Z-1089-2017 | Class III | Optilite IgG4 Kit Product Code: LK009.OPT.A | The Binding Site Group Ltd. | CFN | |
| Z-1211-2017 | Class II | Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 Intended... | Atrium Medical Corporation | CAC | |
| Z-1210-2017 | Class II | Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 Intended Use: To... | Atrium Medical Corporation | KDQ |