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-1482-2020 | Class II | COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model... | Aesculap Inc | JWH | |
| Z-1481-2020 | Class II | AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model... | Aesculap Inc | JWH | |
| Z-1480-2020 | Class II | COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model... | Aesculap Inc | JWH | |
| Z-1479-2020 | Class II | COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model... | Aesculap Inc | JWH | |
| Z-1478-2020 | Class II | Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos... | Aesculap Inc | JWH | |
| Z-1438-2020 | Class II | PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage... | Polymer Technology Systems | MRS | |
| Z-1717-2020 | Class II | Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either... | Sysmex America, Inc. | KQO | |
| Z-1743-2020 | Class II | Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent | Carolina Liquid Chemistries | DJG | |
| Z-1542-2020 | Class II | FlipCutter III Drill | T.A.G. Medical Products Corporation Ltd | HTO | |
| Z-1457-2020 | Class II | Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of... | EHOB, Inc. | IKY | |
| Z-2520-2020 | Class II | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and... | Kentec Medical, LLC | FPD | |
| Z-2519-2020 | Class II | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and... | Kentec Medical, LLC | FPD | |
| Z-2518-2020 | Class II | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and... | Kentec Medical, LLC | FPD | |
| Z-2517-2020 | Class II | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and... | Kentec Medical, LLC | FPD | |
| Z-2516-2020 | Class II | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and... | Kentec Medical, LLC | FPD | |
| Z-2515-2020 | Class II | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and... | Kentec Medical, LLC | FPD | |
| Z-2514-2020 | Class II | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and... | Kentec Medical, LLC | FPD | |
| Z-1673-2020 | Class II | LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data... | Siemens Healthcare Diagnostics Inc. | OUG | |
| Z-1264-2020 | Class II | Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in... | Medtronic, Inc. | GDW | |
| Z-1258-2020 | Class II | SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10... | Ormco/Sybronendo | DZD | |
| Z-1257-2020 | Class II | SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10... | Ormco/Sybronendo | DZD | |
| Z-1391-2020 | Class III | Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage... | Maquet Cardiovascular Us Sales, LLC | MEC | |
| Z-1390-2020 | Class III | Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage... | Maquet Cardiovascular Us Sales, LLC | MEC | |
| Z-1346-2020 | Class II | COHERENCE Oncologist, Model Nos. 07333680 & 07351898 | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1355-2020 | Class II | Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an... | Cook Incorporated | MIH | |
| Z-1964-2020 | Class II | BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and... | Bard Peripheral Vascular Inc | LJT | |
| Z-1456-2020 | Class II | Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for drawing fluid... | Medtronic, Inc. | GEA | |
| Z-1455-2020 | Class II | Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usage: used for... | Medtronic, Inc. | FMI | |
| Z-1454-2020 | Class II | Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usage: used for... | Medtronic, Inc. | FMI | |
| Z-1453-2020 | Class II | Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215... | Medtronic, Inc. | KMF | |
| Z-1218-2020 | Class II | EPIDURAL CATHETERIZATION KIT, Product Code BJC-05400-BEN | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | |
| Z-1217-2020 | Class II | FlexTip Plus Epidural Catheterization Kit, Product Code YC-02220 | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | |
| Z-1216-2020 | Class II | EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-FR1 | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | |
| Z-1215-2020 | Class II | EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-EXP | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | |
| Z-1214-2020 | Class II | EPIDURAL CATHETERIZATION KIT, Product Code UR-05501 | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | |
| Z-1213-2020 | Class II | Epidural Catheterization Kit with FlexTip Plus Catheter, Product Code TI-05520-EPI | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | |
| Z-1212-2020 | Class II | FlexTip Plus Epidural Catheterization Kit, Product Code TI-05501-ME | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | |
| Z-1211-2020 | Class II | FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code NYU-05500-1 | Arrow International LLC (subsidiary of Teleflex Incorporated) | BSO | |
| Z-1210-2020 | Class II | EPIDURAL CATHETERIZATION KIT, Product Code MTO-09903-KU | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | |
| Z-1209-2020 | Class II | FlexTip Plus Epidural Catheterization Set, Product Code MTO-05500-TK | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | |
| Z-1208-2020 | Class II | EPIDURAL CATHETERIZATION KIT, Product Code MTO-05500-SU | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | |
| Z-1207-2020 | Class II | FlexTip Plus Epidural Catheterization Kit, Product Code MP-17019-TKP | Arrow International LLC (subsidiary of Teleflex Incorporated) | BSO | |
| Z-1206-2020 | Class II | FlexTip Plus Epidural Catheterization Set, Product Code MP-17019-TIP | Arrow International LLC (subsidiary of Teleflex Incorporated) | BSO | |
| Z-1205-2020 | Class II | 10 cc Luer-Slip Loss of Resistance Syringe, Product Code LR-05501 | Arrow International LLC (subsidiary of Teleflex Incorporated) | FMF | |
| Z-1204-2020 | Class II | EPIDURAL CATHETERIZATION KIT, Product Code JC-05400-LB | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | |
| Z-1203-2020 | Class II | FlexTip Plus Epidural Catheterization Kit, Product Code JC-05400-E | Arrow International LLC (subsidiary of Teleflex Incorporated) | BSO | |
| Z-1202-2020 | Class II | FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-DCS | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | |
| Z-1201-2020 | Class II | FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-B | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | |
| Z-1200-2020 | Class II | EPIDURAL CATHETERIZATION KIT, Product Code IT-05400-DC | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | |
| Z-1199-2020 | Class II | EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-12 | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ |