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-3212-2011 | Victory 10, 4 Wheel (SC710) Mobility medical device | Pride Mobility Products Corp | INI | ||
| Z-3198-2011 | TSX-101A: AQUILION 16; System, X-Ray, Tomography, Computed X-Ray Tomography | Canon Medical Systems USA, Inc. | JAK | ||
| Z-3197-2011 | TSX-201A: AQUlLlON LB; System, X-Ray, Tomography, Computed X-Ray Tomography | Canon Medical Systems USA, Inc. | JAK | ||
| Z-3196-2011 | TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed X-Ray Tomography | Canon Medical Systems USA, Inc. | JAK | ||
| Z-3195-2011 | TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed X-Ray Tomography | Canon Medical Systems USA, Inc. | JAK | ||
| Z-3211-2011 | Victory 10, 3 Wheel (SC610) Mobility medical device | Pride Mobility Products Corp | INI | ||
| Z-2880-2011 | eSwallow Multi-Program Dysphagia Therapy Test unit Intended Use: Powered Muscle... | Eswallow USA | IPF | ||
| Z-2980-2011 | Symbia Radiation Therapy Pallet. Siemens Medical Solutions USA, Inc. An accessory to... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-3101-2011 | On-Board Imager (OBI) 1.3, 1.4, 1.5; and Trilogy Mx, TrueBeam 1.0, Offline Review 1.0... | Varian Medical Systems, Inc. | IYE | ||
| Z-2782-2011 | Site Rite Vision Ultrasound System, REF 9770032, Bard Access Systems, Inc. Intended for... | Bard Access Systems, Inc. | IYN | ||
| Z-1194-2012 | SYNCHRON Rheumatoid Factor (RF) Reagent, Part Number: 475136 A rheumatoid factor... | Siemens Healthcare Diagnostics Inc. | DHR | ||
| Z-0309-2012 | Arrow International StimuCath(R) Continuous Nerve Block Kit, ASK-19608-SFH, Lot #... | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | ||
| Z-3084-2011 | Maquet HL Console for Heart Lung Machine HL20 HL 20 4-pumps console base: P/N 917741 HL... | Maquet Cardiovascular Us Sales, LLC | DTQ | ||
| Z-3057-2011 | Maquet HL Console for Heart Lung Machine HL20: HL 20 4-pumps console base: P/N 917741 HL... | Maquet Cardiovascular Us Sales, LLC | DTQ | ||
| Z-2964-2011 | Lenstar LS 900 EyeSuite Biometry version i2.000, Four (4) Protective Cardboard Containers... | Haag-Streit USA Inc | HJB | ||
| Z-2979-2011 | MAGNETOM Aera/Skyra System - Nuclear magnetic resonance imaging | Siemens Medical Solutions USA, Inc. | LNH | ||
| Z-2783-2011 | Bard PowerLine 6 Fr. Dual-Lumen Polyurethane Catheter with SureCuff Ingrowth Cuff, REF... | Bard Access Systems, Inc. | LJS | ||
| Z-2988-2011 | Direct Drive Grasper, VARIOUS KITS CONTAINING EITHER C4130 OR C4140 Intended Usage: The... | Applied Medical Resources Corp | GCJ | ||
| Z-2987-2011 | Direct Drive Grasper, Model number C4140, 5MM X 45CM DIRECT DRIVE GRASPER 10/BX Intended... | Applied Medical Resources Corp | GCJ | ||
| Z-2986-2011 | Direct Drive Grasper, Model numbers C4130, 5MM X 35CM DIRECT DRIVE GRASPER... | Applied Medical Resources Corp | GCJ | ||
| Z-2802-2011 | iSert Intraocular Lens (Model PC-60AD) | Hoya Surgical Optics, Inc. | HQL | ||
| Z-2801-2011 | iSymm Intraocular Lens (Model FC-60AD) The Hoya iSymm Model FC-60AD Intraocular Lens... | Hoya Surgical Optics, Inc. | HQL | ||
| Z-2894-2011 | Arrow ASK-20608-CMC StimuCath Continuous Nerve Block Kit. Arrow International... | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | ||
| Z-1499-2012 | MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type... | Siemens Healthcare Diagnostics Inc. | JWY | ||
| Z-1498-2012 | MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type... | Siemens Healthcare Diagnostics Inc. | JWY | ||
| Z-1497-2012 | MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Urine Combo 55; Catalog... | Siemens Healthcare Diagnostics Inc. | JWY | ||
| Z-0174-2012 | 1.0mL 28 G x 1/2" blister packaged insulin syringe Catalog Number 329424; Lot Number... | Becton Dickinson & Co | KZH | ||
| Z-3209-2011 | Brilliance iCT SP Computed Tomography X-Ray System, 510 (k) #K060937, Model #728311... | Philips North America LLC | JAK | ||
| Z-3208-2011 | Brilliance iCT Computed Tomography X-Ray System, 510 (k) #K060937, Model #728306, Serial... | Philips North America LLC | JAK | ||
| Z-2949-2011 | BrightView XCT Gamma Camera, 3/4". Philips Medical Systems, Inc. Intended to produce... | Philips North America LLC | KPS | ||
| Z-2948-2011 | BrightView XCT Gamma Camera, 3/8". Philips Medical Systems, Inc. Intended to produce... | Philips North America LLC | KPS | ||
| Z-2947-2011 | BrightView X Gamma Camera, 3/8". Philips Medical Systems, Inc. Intended to produce... | Philips North America LLC | KPS | ||
| Z-2715-2011 | Pall Total Nutrient Admixture Filter, 1.2 micron filter This filter is a 1.2 micron low... | Pall Life Sciences Puerto Rico LLC | FPB | ||
| Z-2777-2011 | Steerable Coronary Sinus Catheter, Model SCS01, 9 Fr x 20.4", Sterile R, Edwards... | Edwards Lifesciences LLC | DWF | ||
| Z-2776-2011 | Endopledge Sinus Catheter Kit, REF: EP, 9 Fr x 18.9", Sterile EO, Sterile R, Edwards... | Edwards Lifesciences LLC | DWF | ||
| Z-0963-2012 | Sterile surgical kits: DeRoyal SELECTIVE ARTERIOGRAM PACK, REF 89-7284.02 Lot Number... | DeRoyal Industries, Inc. | LRP | ||
| Z-1024-2013 | Class II | Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood... | Zyno Medical LLC. | OPP | |
| Z-0355-2012 | SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12. SoftPath is a laboratory... | SCC Soft Computer | LNX | ||
| Z-0030-2012 | Minutex D-Dimer ; Trinity Biotech plc, Bray, Co. Wicklow, Ireland. Tel: (353) 1 276... | Tcoag Us, Incorporated | GHH | ||
| Z-2794-2011 | Stryker 4.0 mm. Angled Aggressive 12 Degree Blade, Precision Cutters, Stryker... | Stryker Corp. | GFA | ||
| Z-2854-2011 | VirtuoSaph Plus Endoscopic Vessel Harvesting System , REF VSP550, Sterile, Terumo... | Terumo Cardiovascular Systems Corporation | GCJ | ||
| Z-2847-2011 | ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018490, Size 9... | Ansell Healthcare Products LLC | NPD | ||
| Z-2846-2011 | ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018485, Size 8... | Ansell Healthcare Products LLC | NPD | ||
| Z-2845-2011 | ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018480, Size 8... | Ansell Healthcare Products LLC | NPD | ||
| Z-2844-2011 | ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018475, Size 7... | Ansell Healthcare Products LLC | NPD | ||
| Z-2843-2011 | ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018470, Size 7... | Ansell Healthcare Products LLC | NPD | ||
| Z-2842-2011 | ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018465, Size 6... | Ansell Healthcare Products LLC | NPD | ||
| Z-2841-2011 | ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018460, Size 6... | Ansell Healthcare Products LLC | NPD | ||
| Z-2840-2011 | ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018455, Size 5... | Ansell Healthcare Products LLC | NPD | ||
| Z-2881-2011 | Calloway LabsMulti-Drug 9 Panel Assay A rapid, one step screening test for the... | Alere San Diego, Inc. | DKZ |