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-3019-2017 | Class II | VNS Therapy AspireHC Generator, VNS Therapy AspireSR Generator. Model No. 105. Product... | LivaNova USA, Inc. | LYJ | |
| Z-3116-2017 | Class II | BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD... | Becton Dickinson & Co | FMI | |
| Z-2754-2017 | Class II | Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the... | Merge Healthcare Incorporated | NFJ | |
| Z-2766-2019 | Class II | Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose... | Roche Diabetes Care, Inc. | NBW | |
| Z-2765-2019 | Class II | Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose... | Roche Diabetes Care, Inc. | NBW | |
| Z-0516-2018 | Class II | Drill Bit Mini Quick Connect 1.0Mm, Ref 2312-20-200 & 2312-20-202, Non Sterile | Zimmer GmbH | LXH | |
| Z-0273-2018 | Class II | VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical... | Ortho-Clinical Diagnostics, Inc. | DIP | |
| Z-2778-2017 | Class II | INVUITY(R) PhotonBlade(TM), REF PB1 | Invuity, Inc. | GEI | |
| Z-2699-2017 | Class II | Arrow Glide Thru Peel-Away Sheath/Dilator Introducer | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | |
| Z-2698-2017 | Class II | Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-2700-2017 | Class II | Alaris Pump Module model 8100 | CareFusion 303, Inc | FRN | |
| Z-2671-2017 | Class II | Alaris PC Unit, Model 8015 | CareFusion 303, Inc | FRN | |
| Z-0492-2018 | Class II | TosohSorter 9tray, Product Code 022931and TosohSorter 19tray, Product Code... | Tosoh Bioscience Inc | KHO | |
| Z-0491-2018 | Class II | TosohAutomated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product... | Tosoh Bioscience Inc | KHO | |
| Z-1873-2018 | Class II | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004 | Kelyniam Global, Inc. | GXN | |
| Z-1872-2018 | Class II | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003 | Kelyniam Global, Inc. | GXN | |
| Z-1871-2018 | Class II | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002 | Kelyniam Global, Inc. | GXN | |
| Z-1870-2018 | Class II | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small) | Kelyniam Global, Inc. | GXN | |
| Z-2871-2017 | Class II | Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product... | LivaNova USA, Inc. | DWF | |
| Z-2702-2017 | Class I | Penumbra 3D Revascularization Device It is indicated for used in the revascularization of... | Penumbra Inc. | NRY | |
| Z-2729-2017 | Class II | Nicolet Elite 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500. Intended for... | Medtronic, Inc. | JAF | |
| Z-2728-2017 | Class II | Nicolet Elite 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for... | Medtronic, Inc. | JAF | |
| Z-2727-2017 | Class II | Nicolet Elite 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20. Intended... | Medtronic, Inc. | JAF | |
| Z-2726-2017 | Class II | Nicolet Elite 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code... | Medtronic, Inc. | JAF | |
| Z-0625-2018 | Class II | Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number... | Roche Diabetes Care, Inc. | NDC | |
| Z-0197-2018 | Class II | Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN... | Roche Diabetes Care, Inc. | NDC | |
| Z-0311-2019 | Class II | Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2 Product... | Philips North America LLC | JAK | |
| Z-0310-2019 | Class II | Ingenuity Core 128 (Model No. 728323), Software version 4.1.6 Product Usage: Computed... | Philips North America LLC | JAK | |
| Z-0309-2019 | Class II | Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: Computed... | Philips North America LLC | JAK | |
| Z-0308-2019 | Class II | Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: Computed... | Philips North America LLC | JAK | |
| Z-0307-2019 | Class II | Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 Product... | Philips North America LLC | JAK | |
| Z-0306-2019 | Class II | IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Product... | Philips North America LLC | JAK | |
| Z-0305-2019 | Class II | Brilliance iCT (Model No. 728306), Software Version 4.1.6 Product Usage: Computed... | Philips North America LLC | JAK | |
| Z-0304-2019 | Class II | Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: Computed... | Philips North America LLC | JAK | |
| Z-0303-2019 | Class II | Brilliance Big Bore Oncology CT (Model No. 728243) software version 4.2.0 Product... | Philips North America LLC | JAK | |
| Z-0515-2018 | Class II | ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number... | Siemens Healthcare Diagnostics Inc. | CHP | |
| Z-0230-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product... | Terumo Medical Corp. | DYB | |
| Z-0229-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product... | Terumo Medical Corp. | DYB | |
| Z-0228-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product... | Terumo Medical Corp. | DYB | |
| Z-0227-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021), REF/Product... | Terumo Medical Corp. | DYB | |
| Z-0226-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product... | Terumo Medical Corp. | DYB | |
| Z-0225-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product... | Terumo Medical Corp. | DYB | |
| Z-0224-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021), REF/Product... | Terumo Medical Corp. | DYB | |
| Z-0223-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product... | Terumo Medical Corp. | DYB | |
| Z-0222-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.025)... | Terumo Medical Corp. | DYB | |
| Z-0221-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021)... | Terumo Medical Corp. | DYB | |
| Z-0220-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021)... | Terumo Medical Corp. | DYB | |
| Z-0219-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.025)... | Terumo Medical Corp. | DYB | |
| Z-0218-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021)... | Terumo Medical Corp. | DYB | |
| Z-0217-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.021)... | Terumo Medical Corp. | DYB |