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-2327-2015 | Class II | Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton... | Titan Spine, LLC | OVE | |
| Z-2749-2015 | Class II | Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and... | Elcam Medical, Inc. | LZG | |
| Z-2748-2015 | Class II | Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for... | Elcam Medical, Inc. | LZG | |
| Z-0788-2022 | Class III | LYFO Disk | Microbiologics, Inc. | JTR | |
| Z-2803-2015 | Class II | PET Discovery ST 16 | GE Healthcare | KPS | |
| Z-2802-2015 | Class II | PET Discovery LS | GE Healthcare | KPS | |
| Z-2801-2015 | Class II | Lightspeed 16 CT | GE Healthcare | JAK | |
| Z-2453-2015 | Class II | BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number... | Becton, Dickinson and Company, BD Biosciences | MVU | |
| Z-2809-2015 | Class II | MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No... | Siemens Healthcare Diagnostics Inc. | OUG | |
| Z-2325-2015 | Class II | Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use... | Medtronic Navigation, Inc | HAW | |
| Z-2324-2015 | Class II | Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit... | Medtronic Navigation, Inc | HAW | |
| Z-2375-2015 | Class II | Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed... | Advanced Sterilization Products | MLR | |
| Z-0224-2016 | Class II | Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN#... | Mako Surgical Corp. | OLO | |
| Z-2417-2015 | Class II | Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The... | Radiometer America, Inc | LKD | |
| Z-2373-2015 | Class II | Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-2261-2015 | Class II | Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint... | Otto Bock Healthcare LP | ISY | |
| Z-2329-2015 | Class I | Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled)... | Medtronic, Inc. | CBK | |
| Z-2441-2015 | Class II | iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079... | International Remote Imaging Systems | KQO | |
| Z-2741-2015 | Class II | Dimension CREA (Creatinine) and Dimension Vista CREA (Creatinine); The CREA method used... | Siemens Healthcare Diagnostics Inc. | JFY | |
| Z-2264-2015 | Class I | EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C... | Medtronic Heart Valves Division | NPT | |
| Z-0001-2016 | Class II | Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be... | United States Endoscopy Group, Inc. | FDI | |
| Z-0026-2016 | Class II | Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5... | Ortho Solutions Inc | HWC | |
| Z-2447-2015 | Class II | cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas b 123 POC... | Roche Diagnostics GmbH | CHL | |
| Z-2446-2015 | Class II | cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC... | Roche Diagnostics GmbH | CHL | |
| Z-2338-2015 | Class II | Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301 | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2337-2015 | Class II | Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302 | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2336-2015 | Class II | Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290 | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2335-2015 | Class II | Biograph mCT Flow Edge-4R, Model Number 10528955 | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2334-2015 | Class II | SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743 | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2333-2015 | Class II | Biograph mCT X-4R, Model Number 10248670 | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2332-2015 | Class II | Biograph mCT S(64)-4R, Model Number 10248672 | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2331-2015 | Class II | Biograph mCT S(40)-4R, Model Number 10248671 | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2390-2015 | Class II | RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use... | Sedecal S.A. | IZL | |
| Z-2343-2015 | Class I | PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the... | Draeger, Inc. | CBK | |
| Z-2485-2015 | Class I | OmniPod Insulin Management System. Only the OmniPod device is affected. Catalog... | Insulet Corporation | LZG | |
| Z-2484-2015 | Class I | OmniPod Insulin Management System. Only the OmniPod device is affected. Catalog... | Insulet Corporation | LZG | |
| Z-2381-2015 | Class II | Etac Relax wall mounted shower seat The Etac Relax is a wall mounted shower seat designed... | Etac Supply Center AB | ILS | |
| Z-2717-2015 | Class II | C-SECTION PK 2/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | OHM | |
| Z-2716-2015 | Class II | PERI GYN PACK 5/CS Used by medical staff to perform surgical procedures and... | Customed, Inc | OKV | |
| Z-2715-2015 | Class II | LAPAROTOMY PACK 3/CS Used by medical staff to perform surgical procedures and... | Customed, Inc | LRO | |
| Z-2714-2015 | Class II | ARTHROSCOPY PK L/F 5/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | OJH | |
| Z-2713-2015 | Class II | CATARACT PACK 6/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | OJK | |
| Z-2712-2015 | Class II | C-SECTION SURGICAL PACK 2/CS Used by medical staff to perform surgical procedures... | Customed, Inc | OHM | |
| Z-2468-2015 | Class II | Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar... | Stryker Sustainability Solutions | NLM | |
| Z-2339-2015 | Class II | GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed... | GE Healthcare | LNH | |
| Z-2711-2015 | Class II | PLASTIC SURGERY PACK 5/CS Used by medical staff to perform surgical procedures and... | Customed, Inc | LRO | |
| Z-2710-2015 | Class II | CURATION KIT 10/CS Used by medical staff to perform surgical procedures and patient care... | Customed, Inc | FMH | |
| Z-2709-2015 | Class II | ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | HRX | |
| Z-2708-2015 | Class II | UROLOGY PACK 5/CS Used by medical staff to perform surgical procedures and patient care... | Customed, Inc | KNX | |
| Z-2707-2015 | Class II | CESAREAN PK 4/CS Used by medical staff to perform surgical procedures and patient care... | Customed, Inc | OHM |