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-2112-2017 | Class II | OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, OVATIO DR... | Corcym Inc. | MRM | |
| Z-2073-2017 | Class II | Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600 | Biomet Microfixation | HWT | |
| Z-3119-2017 | Class II | eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the... | bioMerieux, Inc. | JJH | |
| Z-2155-2017 | Class II | CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units... | B Braun Medical Inc | FPA | |
| Z-2173-2017 | Class II | Elecsys PreciControl Varia 3 | Roche Diagnostics GmbH | JJY | |
| Z-2040-2017 | Class II | RAPIDPoint 500 Blood Gas Analyzer with v2.4 software for professional use in a... | Siemens Healthcare Diagnostics Inc. | CHL | |
| Z-2054-2017 | Class II | CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part... | CooperSurgical, Inc. | HHW | |
| Z-2097-2017 | Class II | Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to... | Ion Beam Applications S.A. | LHN | |
| Z-2704-2017 | Class II | Exactech Optetrak Logic CC 15mm Tibial Augment Screws | Exactech, Inc. | JWH | |
| Z-1885-2017 | Class II | 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material... | Spinal Elements, Inc | LXH | |
| Z-0350-2018 | Class II | Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip... | Merge Healthcare Incorporated | DQK | |
| Z-1891-2017 | Class II | DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND... | Perouse Medical | MAV | |
| Z-2098-2017 | Class II | SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and... | Bausch & Lomb Incorporated | MSS | |
| Z-2086-2017 | Class II | ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in... | Siemens Healthcare Diagnostics Inc. | CFP | |
| Z-2085-2017 | Class II | ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number... | Siemens Healthcare Diagnostics Inc. | JIT | |
| Z-1922-2017 | Class II | The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking... | Boston Scientific Corporation | MCW | |
| Z-0106-2019 | Class II | "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free... | Helena Laboratories, Corp. | GGP | |
| Z-1496-2018 | Class II | MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating... | Ortho-Clinical Diagnostics, Inc. | DAK | |
| Z-2670-2017 | Class II | Jelco, Hypodermic needle Pro needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2"... | Abbott Medical | FMI | |
| Z-2172-2017 | Class II | Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is... | Ellex Medical Pty Ltd | GEX | |
| Z-2050-2017 | Class II | Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1... | Curon Medical, Inc. | GEI | |
| Z-2084-2017 | Class II | Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative... | Siemens Healthcare Diagnostics Inc. | DKJ | |
| Z-2083-2017 | Class II | Triglycerides Reagent (TG 2 x 300), Catalog No. 445850. Intended for quantitative... | Siemens Healthcare Diagnostics Inc. | CDT | |
| Z-2082-2017 | Class II | HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative... | Siemens Healthcare Diagnostics Inc. | LBS | |
| Z-2081-2017 | Class II | Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative... | Siemens Healthcare Diagnostics Inc. | CHH | |
| Z-2080-2017 | Class II | Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended for the... | Siemens Healthcare Diagnostics Inc. | JFY | |
| Z-2079-2017 | Class II | Uric Acid Reagent (URIC 2 x 300), Catalog No. 442785. Intended for the quantitative... | Siemens Healthcare Diagnostics Inc. | KNK | |
| Z-2078-2017 | Class II | Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative... | Siemens Healthcare Diagnostics Inc. | CFJ | |
| Z-2035-2017 | Class II | AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product... | Siemens Healthcare Diagnostics Inc. | OYE | |
| Z-0208-2018 | Class II | Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1)... | Intersurgical Ltd. | BYG | |
| Z-1924-2017 | Class II | Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008... | Natus Medical Incorporated | LBI | |
| Z-2067-2017 | Class II | Healon V, Part No. 10290045 | Advanced Medical Optics, Inc. | LZP | |
| Z-2066-2017 | Class II | Healon Pro, Part No. 10270012 | Advanced Medical Optics, Inc. | LZP | |
| Z-2065-2017 | Class II | Healon 5 Pro, Part No. 10270015 | Advanced Medical Optics, Inc. | LZP | |
| Z-2064-2017 | Class II | Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012 | Advanced Medical Optics, Inc. | LZP | |
| Z-2063-2017 | Class II | Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014 | Advanced Medical Optics, Inc. | LZP | |
| Z-2062-2017 | Class II | Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012... | Advanced Medical Optics, Inc. | LZP | |
| Z-3042-2017 | Class II | Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US | C.R. Bard Inc | DWJ | |
| Z-2733-2017 | Class I | ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR... | Oscor Inc. | IKD | |
| Z-2174-2017 | Class II | Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM | Ethicon Endo-Surgery Inc | GDW | |
| Z-1819-2017 | Class II | da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE... | Intuitive Surgical, Inc. | NAY | |
| Z-2340-2017 | Class I | ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912... | Oscor Inc. | IKD | |
| Z-0527-2019 | Class II | Optional MDRC-1119 Front Cover Attachment Kit for review display monitors. Product... | Barco N.V. | OWB | |
| Z-2096-2017 | Class II | AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and... | Advanced Medical Optics, Inc. | MLZ | |
| Z-1908-2017 | Class II | If Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products are sterile... | Breg Inc | KGX | |
| Z-1907-2017 | Class II | Dressing Back, P/N 09810 Product Usage: These products are sterile dressings used as an... | Breg Inc | KGX | |
| Z-1906-2017 | Class II | Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used as... | Breg Inc | KGX | |
| Z-1905-2017 | Class II | Dressing Shldr, P/N 04908 Product Usage: These products are sterile dressings used as an... | Breg Inc | KGX | |
| Z-1904-2017 | Class II | Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used... | Breg Inc | KGX | |
| Z-1903-2017 | Class II | Dressing Rect L, P/N 02428 Product Usage: These products are sterile dressings used as... | Breg Inc | KGX |