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-0690-2020 | Class II | Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, Product Code... | Teleflex Medical | FMI | |
| Z-0689-2020 | Class II | Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code... | Teleflex Medical | FMI | |
| Z-0688-2020 | Class II | Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code... | Teleflex Medical | FMI | |
| Z-0371-2020 | Class II | CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with... | Halyard Health | KNT | |
| Z-0370-2020 | Class II | CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2... | Halyard Health | KNT | |
| Z-0654-2021 | Class II | Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/... | Nova Ortho-Med Inc | ITJ | |
| Z-2070-2020 | Class II | NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545... | Baylis Medical Co., Inc. | DYB | |
| Z-1928-2020 | Class II | Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The... | Edwards Lifesciences LLC | DQK | |
| Z-2110-2020 | Class II | Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI... | The Binding Site Group Ltd. | DHR | |
| Z-2069-2020 | Class II | TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55... | Baylis Medical Co., Inc. | DYB | |
| Z-1041-2020 | Class II | Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213 | Implant Direct Sybron Manufacturing LLC | DZE | |
| Z-0516-2020 | Class II | UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II)... | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-0406-2020 | Class II | Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0351-2020 | Class II | LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails... | Smith & Nephew, Inc. | LXH | |
| Z-2262-2020 | Class II | Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended... | Ventana Medical Systems Inc | KPA | |
| Z-1920-2020 | Class II | REF: Z3806, 131" (333 cm) 10 Drop Primary Set w/2 MicroClave, Remv 4 Gang 4-way Stopcocks... | Abbott Medical | FMG | |
| Z-1919-2020 | Class II | REF: Z3239, 126" 10 Drop Primary Set w/3 MicroClave, 2 Gang 4-Way Stopcocks, Rotating... | Abbott Medical | FMG | |
| Z-1918-2020 | Class II | REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 Manifold w/3... | Abbott Medical | FMG | |
| Z-1917-2020 | Class II | REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopcocks... | Abbott Medical | FMG | |
| Z-1916-2020 | Class II | REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure... | Abbott Medical | FPA | |
| Z-1915-2020 | Class II | REF: MC330424, 145" (368 cm) Appx 19.8 ml, 10 Drop Primary Set w/4 MicroClave Clear, Remv... | Abbott Medical | FMG | |
| Z-1914-2020 | Class II | REF: B9900-287, 82" (208 cm) Appx 10.4 ml, 10 Drop Admin Set, w/Pre-Slit Port, Clave, 1... | Abbott Medical | FMG | |
| Z-1913-2020 | Class II | REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing, Pre-Slit... | Abbott Medical | FMG | |
| Z-1912-2020 | Class II | REF: B30211, 37" (94 cm) Appx 4.2 ml, 10 Drop Admin Set W/Luer Lock, Bag Hanger, Sterile... | Abbott Medical | FMG | |
| Z-1911-2020 | Class II | REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For... | Abbott Medical | FMG | |
| Z-0511-2020 | Class II | Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS)... | Neocis Inc. | PLV | |
| Z-0414-2020 | Class II | Randox Liquid Cardiac Controls Catalogue Numbers CQ5053. | Randox Laboratories, Limited | JJY | |
| Z-0413-2020 | Class II | Randox Liquid Cardiac Controls Catalogue Number CQ5052. | Randox Laboratories, Limited | JJY | |
| Z-0412-2020 | Class II | Randox Liquid Cardiac Controls Catalogue Number CQ5051 | Randox Laboratories, Limited | JJY | |
| Z-0497-2020 | Class II | WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965... | Teleflex Medical | FZP | |
| Z-0496-2020 | Class II | WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic... | Teleflex Medical | FZP | |
| Z-0679-2020 | Class II | Roche Homocysteine-In vitro test for the quantitative determination of total... | Roche Diagnostics GmbH | LPS | |
| Z-0250-2020 | Class II | Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use. | Cordis US Corp. | LIT | |
| Z-0280-2020 | Class II | Prismaflex Control Unit, software versions below 7.21 | Baxter Healthcare Corporation | KDI | |
| Z-0279-2020 | Class II | Prismaflex Control Unit, software versions below 7.21 | Baxter Healthcare Corporation | KDI | |
| Z-0278-2020 | Class II | Prismaflex Control Unit, software versions below 7.21 | Baxter Healthcare Corporation | KDI | |
| Z-0277-2020 | Class II | Prismaflex Control Unit, software versions below 7.21 | Baxter Healthcare Corporation | KDI | |
| Z-0276-2020 | Class II | Prismaflex Control Unit, software versions below 7.21 | Baxter Healthcare Corporation | KDI | |
| Z-0608-2020 | Class II | HeartStart XL+ Defibrillator/Monitor, Model 861290 | Philips North America LLC | MKJ | |
| Z-0514-2020 | Class II | Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a... | Howmedica Osteonics Corp | LPH | |
| Z-0416-2020 | Class II | Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the... | Cook Incorporated | MQF | |
| Z-0415-2020 | Class II | Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the... | Cook Incorporated | MQF | |
| Z-0241-2020 | Class II | Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager | Medtronic, Inc. | OSR | |
| Z-0240-2020 | Class II | Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer | Medtronic, Inc. | OSR | |
| Z-0239-2020 | Class II | Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer | Medtronic, Inc. | OSR | |
| Z-0266-2020 | Class II | Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300... | Datascope Corp. | MHX | |
| Z-0203-2020 | Class I | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A | Ethicon Endo-Surgery Inc | GDW | |
| Z-0202-2020 | Class I | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A | Ethicon Endo-Surgery Inc | GDW | |
| Z-0201-2020 | Class I | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A | Ethicon Endo-Surgery Inc | GDW | |
| Z-0200-2020 | Class I | ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A | Ethicon Endo-Surgery Inc | GDW |