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-1817-2017 | Class II | Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445... | Micromedics, Inc. | KGZ | |
| Z-0692-2017 | Class II | SOMATOM Force, System x-ray, tomography, computed | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0411-2017 | Class II | MEVION S250 Product Usage: Proton Radiation Therapy System | Mevion Medical Systems, Inc. | MUJ | |
| Z-0707-2017 | Class II | Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software... | Merge Healthcare Incorporated | LLZ | |
| Z-2790-2018 | Class II | Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product... | Guangzhou Improve Medical Instruments Co., Ltd. | FMI | |
| Z-1190-2017 | Class II | Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical... | Greatbatch Medical | LXH | |
| Z-0605-2017 | Class II | SOMATOM Definition Flash, Computed tomography system Product Usage: SOMATOM Definition... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0604-2017 | Class II | SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0613-2017 | Class II | ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA... | Siemens Healthcare Diagnostics Inc. | NIG | |
| Z-0612-2017 | Class II | ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA... | Siemens Healthcare Diagnostics Inc. | NIG | |
| Z-0374-2017 | Class II | SOMATOM Definition Flash system, x-ray, tomography, computed | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0373-2017 | Class II | SOMATOM Definition AS system, x-ray, tomography, computed | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0648-2017 | Class II | AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is... | Siemens Healthcare Diagnostics Inc. | OYE | |
| Z-0785-2017 | Class II | Ultroid Sterile Disposable Probes sold individually | Hudson Scientific LLC | KNS | |
| Z-0784-2017 | Class II | Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes. | Hudson Scientific LLC | KNS | |
| Z-0783-2017 | Class II | Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable... | Hudson Scientific LLC | KNS | |
| Z-0782-2017 | Class II | Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the... | Hudson Scientific LLC | KNS | |
| Z-1177-2017 | Class II | Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal... | Teleflex Medical | BTR | |
| Z-0658-2017 | Class II | ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number... | ConforMIS, Inc. | JWH | |
| Z-0332-2017 | Class II | Xhibit Central Station, Model 96102. Intended use is to provide clinicians with... | GE Healthcare | MHX | |
| Z-1770-2017 | Class II | Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI... | Siemens Medical Solutions USA, Inc. | LNH | |
| Z-0951-2017 | Class II | Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket... | Natus Manufacturing Limited | LGZ | |
| Z-2434-2019 | Class II | Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL | Helena Laboratories, Corp. | JJY | |
| Z-0610-2017 | Class III | OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with... | Omni Life Science, Inc. | OLO | |
| Z-0756-2017 | Class II | Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged... | Medtronic, Inc. | FMH | |
| Z-0392-2017 | Class II | ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No... | Medtimo, Inc. | LTI | |
| Z-0780-2017 | Class II | PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. Used with... | Revvity Health Sciences, Inc. | JQW | |
| Z-0598-2017 | Class III | IQon Spectral CT Computed Tomography X-ray system, Model 728332 | Philips North America LLC | JAK | |
| Z-0597-2017 | Class III | Ingenuity Core Computed Tomography X-ray system, Model 728321 | Philips North America LLC | JAK | |
| Z-0596-2017 | Class III | Ingenuity Core 128 Computed Tomography X-ray system, Model 728323 | Philips North America LLC | JAK | |
| Z-0595-2017 | Class III | Ingenuity CT Computed Tomography X-ray system, Model 728326 | Philips North America LLC | JAK | |
| Z-0594-2017 | Class III | Brilliance ICT SP Computed Tomography X-ray system, Model 728311 | Philips North America LLC | JAK | |
| Z-0593-2017 | Class III | Brilliance iCT Computed Tomography X-ray system, Model 728306 | Philips North America LLC | JAK | |
| Z-0406-2017 | Class II | Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA... | C.R. Bard Inc | FAD | |
| Z-0405-2017 | Class II | Bard Inlay Optima Multi-Length Ureteral Stent Coated Double Pigtail Ureteral Stent with... | C.R. Bard Inc | FAD | |
| Z-0404-2017 | Class II | BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014. | C.R. Bard Inc | FAD | |
| Z-0403-2017 | Class II | Bard Fluoro-4 Silicone Ureteral Stent, Bard Fluoro-4", Silicone Ureteral Coil Stent; Bard... | C.R. Bard Inc | FAD | |
| Z-0983-2017 | Class II | Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical... | Bausch & Lomb Incorporated | OHW | |
| Z-0741-2017 | Class II | McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136... | Cypress Medical Products LLC | LYZ | |
| Z-0630-2017 | Class II | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x... | DePuy Spine, Inc. | KWQ | |
| Z-0629-2017 | Class II | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x... | DePuy Spine, Inc. | KWQ | |
| Z-0628-2017 | Class II | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x... | DePuy Spine, Inc. | KWQ | |
| Z-0627-2017 | Class II | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x... | DePuy Spine, Inc. | KWQ | |
| Z-0626-2017 | Class II | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x... | DePuy Spine, Inc. | KWQ | |
| Z-0625-2017 | Class II | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x... | DePuy Spine, Inc. | KWQ | |
| Z-0624-2017 | Class II | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x... | DePuy Spine, Inc. | KWQ | |
| Z-0363-2017 | Class II | X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8... | C.R. Bard Inc | LJE | |
| Z-0588-2017 | Class II | Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The... | Alere San Diego, Inc. | JJY | |
| Z-0585-2017 | Class II | C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx only... | C.R. Bard Inc | FAS | |
| Z-0370-2017 | Class II | GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code... | Baxter Healthcare Corporation | KDL |