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-1966-2018 | Class II | Maximal Barrier Drape; Product Code: ASK-01000-UPMS | Arrow International LLC (subsidiary of Teleflex Incorporated) | KDD | |
| Z-1965-2018 | Class II | Maximal Barrier Drape; Product Codes: ASK-00376-SU | Arrow International LLC (subsidiary of Teleflex Incorporated) | KDD | |
| Z-1964-2018 | Class II | Maximal Barrier Drape; Product Codes: ASK-00002-1A | Arrow International LLC (subsidiary of Teleflex Incorporated) | KKX | |
| Z-1963-2018 | Class II | Maximal Barrier Drape; Product Codes: ASK-00001-1A | Arrow International LLC (subsidiary of Teleflex Incorporated) | KKX | |
| Z-1962-2018 | Class II | SnapLock" Catheter/Syringe Adapter; Product Code: AS-05500 | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | |
| Z-1961-2018 | Class II | Epidural Needle; Product Codes: AN-05501 and AN-05505 | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | |
| Z-1960-2018 | Class II | Spring Wire Guide Introducer Needle; Product Codes: AN-04320 and AN-04418 | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQY | |
| Z-1959-2018 | Class II | Echogenic Introducer Needle; Product Code: AN-04318 | Arrow International LLC (subsidiary of Teleflex Incorporated) | FMI | |
| Z-1958-2018 | Class II | Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N, AB-17080-N... | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | |
| Z-1957-2018 | Class II | Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires... | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | |
| Z-1781-2018 | Class II | NvisionVLE Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI... | Ninepoint Medical, Inc. | NQQ | |
| Z-1697-2019 | Class II | CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery... | Accuray Incorporated | IYE | |
| Z-1696-2019 | Class II | CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b)... | Accuray Incorporated | IYE | |
| Z-1702-2018 | Class II | BARD BrachySource Iodine125 radioactive seeds consist of a welded titanium capsule... | Bard Brachytherapy, Inc. | KXK | |
| Z-2288-2018 | Class II | HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160... | Cenorin, LLC | LDS | |
| Z-2337-2018 | Class II | Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135 | Terumo Medical Corp. | MGB | |
| Z-2100-2018 | Class II | VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit | VGI medical, LLC | OVD | |
| Z-1528-2018 | Class II | EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, Product... | Medtronic, Inc. | GDW | |
| Z-1527-2018 | Class II | EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product... | Medtronic, Inc. | GDW | |
| Z-1902-2018 | Class II | smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The... | Smith & Nephew, Inc. | MBH | |
| Z-2331-2018 | Class II | VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA... | bioMerieux, Inc. | CGJ | |
| Z-1869-2018 | Class II | DriSate Product Code DR-145 The acid concentrate powders and liquids are indicated for... | Rockwell Medical | KPO | |
| Z-0435-2019 | Class II | OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G | AROA Biosurgery Inc. | FTM | |
| Z-0434-2019 | Class II | OviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822G | AROA Biosurgery Inc. | FTM | |
| Z-0433-2019 | Class II | OviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020G | AROA Biosurgery Inc. | FTM | |
| Z-0432-2019 | Class II | OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G | AROA Biosurgery Inc. | FTM | |
| Z-0431-2019 | Class II | OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G | AROA Biosurgery Inc. | FTM | |
| Z-0430-2019 | Class II | OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G | AROA Biosurgery Inc. | FTM | |
| Z-0429-2019 | Class II | OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G | AROA Biosurgery Inc. | FTM | |
| Z-0428-2019 | Class II | OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G | AROA Biosurgery Inc. | FTM | |
| Z-0427-2019 | Class II | OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G | AROA Biosurgery Inc. | FTM | |
| Z-0426-2019 | Class II | OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822G | AROA Biosurgery Inc. | FTM | |
| Z-0425-2019 | Class II | OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G | AROA Biosurgery Inc. | FTM | |
| Z-0424-2019 | Class II | OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G | AROA Biosurgery Inc. | FTM | |
| Z-0423-2019 | Class II | OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G | AROA Biosurgery Inc. | FTM | |
| Z-0422-2019 | Class II | OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G | AROA Biosurgery Inc. | FTM | |
| Z-0421-2019 | Class II | OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G | AROA Biosurgery Inc. | FTM | |
| Z-0420-2019 | Class II | OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G | AROA Biosurgery Inc. | FTM | |
| Z-0419-2019 | Class II | OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G | AROA Biosurgery Inc. | FTM | |
| Z-0418-2019 | Class II | OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G | AROA Biosurgery Inc. | FTM | |
| Z-0417-2019 | Class II | OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G | AROA Biosurgery Inc. | FTM | |
| Z-0416-2019 | Class II | OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G | AROA Biosurgery Inc. | FTM | |
| Z-0415-2019 | Class II | OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G | AROA Biosurgery Inc. | FTM | |
| Z-1780-2018 | Class II | EasyTouch (ET) Insulin Syringe 29G 0.5ml " (Item 829555) Product Usage: INTENDED FOR... | MHC Medical Products | FMI | |
| Z-1779-2018 | Class II | EasyTouch (ET) Insulin Syringe 29G 1ml " (Item 829155) Product Usage: INTENDED FOR... | MHC Medical Products | FMI | |
| Z-2135-2018 | Class II | Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small... | Orthofix SRL | HRS | |
| Z-2134-2018 | Class II | T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small... | Orthofix SRL | HRS | |
| Z-2133-2018 | Class II | TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small... | Orthofix SRL | HRS | |
| Z-2132-2018 | Class II | Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part Number): a)... | Orthofix SRL | HRS | |
| Z-2131-2018 | Class II | MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small... | Orthofix SRL | HRS |