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-2212-2017 | Class III | Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used... | Neogen Culture Media | JSG | |
| Z-0745-2017 | Class II | BD 23 G x .75 in. BD Vacutainer Push Button Blood Collection Set with 12 in... | Becton Dickinson & Co | JKA | |
| Z-0003-2017 | Class II | Vanguard 360 Revision Knee System Knee prostheses | Zimmer GmbH | JWH | |
| Z-2741-2016 | Class II | Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQX | |
| Z-2740-2016 | Class II | Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQX | |
| Z-2899-2016 | Class II | Siemens ADVIA Centaur Calibrator U, For in vitro diagnostic use in calibrating the... | Siemens Healthcare Diagnostics Inc. | DDR | |
| Z-2732-2016 | Class II | UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465... | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-2710-2016 | Class II | BD Vacutainer Push Button Blood Collection Set, Sterile, Rx only, 0.6 x 19 mm x 305 mm... | Becton Dickinson & Co | JKA | |
| Z-2711-2016 | Class II | SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK... | Nidek Incorporated | NQE | |
| Z-2845-2016 | Class II | 3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only. | ZimVie US Corp LLC | DZE | |
| Z-2879-2016 | Class II | Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump... | CareFusion 303, Inc | FRN | |
| Z-2173-2018 | Class II | Proteus 235 The PTS is a medical device designed to produce and deliver a proton beam... | Ion Beam Applications S.A. | LHN | |
| Z-2853-2016 | Class II | Syngo.via picture archiving and communication system Syngo via is a software solution... | Siemens Medical Solutions USA, Inc. | LLZ | |
| Z-2852-2016 | Class II | Syngo.x picture archiving and communication system Syngo.x is a software solution... | Siemens Medical Solutions USA, Inc. | LLZ | |
| Z-2898-2016 | Class II | CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2... | Medtronic, Inc. | PHV | |
| Z-2762-2016 | Class II | Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part... | Riverpoint Medical, LLC | GAR | |
| Z-2761-2016 | Class II | Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon... | Riverpoint Medical, LLC | GAR | |
| Z-2758-2016 | Class II | e.cam and Symbia E gamma camera systems with patient beds To detect or image the... | Siemens Medical Solutions USA, Inc. | IYX | |
| Z-0669-2017 | Class II | MISAGO RX Self Expanding Peripheral Stem | Terumo Medical Corp. | NIP | |
| Z-1015-2017 | Class II | Infant Warmer System (IWS) | GE Healthcare | FMT | |
| Z-2829-2016 | Class II | AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for... | AirStrip Technologies, Inc. | LQK | |
| Z-2542-2016 | Class II | Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System... | Canon Medical Systems USA, Inc. | IYN | |
| Z-2692-2016 | Class II | UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel... | Siemens Healthcare Diagnostics Inc. | BSZ | |
| Z-2684-2016 | Class II | INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile. | Integra Pain Management | CAZ | |
| Z-0738-2017 | Class II | BARDIA 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD Syringe is available in... | C.R. Bard Inc | KYZ | |
| Z-0737-2017 | Class II | BARD Piston Syringe, 60cc, Rx Only, Sterile, The BARD Syringe is available in a single... | C.R. Bard Inc | KYZ | |
| Z-0736-2017 | Class II | BARD 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, The BARD... | C.R. Bard Inc | KYZ | |
| Z-0735-2017 | Class II | BARD Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adapter And Cap... | C.R. Bard Inc | KYZ | |
| Z-0039-2017 | Class II | Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443 Batch... | Siemens Healthcare Diagnostics Inc. | CIC | |
| Z-2545-2016 | Class II | 1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product Usage: The HYDRO... | LeMaitre Vascular Inc. | MGZ | |
| Z-2544-2016 | Class II | 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product... | LeMaitre Vascular Inc. | MGZ | |
| Z-2543-2016 | Class II | 1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The... | LeMaitre Vascular Inc. | MGZ | |
| Z-2546-2016 | Class II | Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and... | Medtronic Heart Valves Division | NPT | |
| Z-0087-2017 | Class II | Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smooth A... | Zimmer GmbH | HTY | |
| Z-0123-2017 | Class II | Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to... | Randox Laboratories, Limited | CDT | |
| Z-0394-2017 | Class II | catalog # 405612 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Quincke Spinal... | Becton Dickinson & Co | CAZ | |
| Z-2794-2016 | Class II | Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read... | Siemens Medical Solutions USA, Inc. | LLZ | |
| Z-2793-2016 | Class II | Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display... | Siemens Medical Solutions USA, Inc. | LLG | |
| Z-0367-2017 | Class I | Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~... | Greatbatch Medical | HWA | |
| Z-2768-2016 | Class II | Certegra Workstation used in conjunction with Medrad Stellant CT Injection System... | Medrad, Inc. | DXT | |
| Z-2778-2016 | Class III | LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with... | Alere San Diego, Inc. | LBS | |
| Z-2714-2016 | Class II | Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one... | Best Sanitizers, Inc. | MED | |
| Z-2766-2016 | Class II | SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB... | Hologic, Inc. | GDF | |
| Z-2765-2016 | Class II | SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB... | Hologic, Inc. | GDF | |
| Z-0015-2017 | Class II | YSIO Max Product Usage: The Ysio Max is a radiographic system used in hospitals... | Siemens Medical Solutions USA, Inc. | KPR | |
| Z-0316-2017 | Class II | Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture | Aesculap Inc | GAM | |
| Z-0014-2017 | Class II | Multix Fusion VA10 Product Usage: The Multix Fusion VA10 system is a radiographic system... | Siemens Medical Solutions USA, Inc. | KPR | |
| Z-0013-2017 | Class II | Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a... | Siemens Medical Solutions USA, Inc. | KPR | |
| Z-2789-2016 | Class II | Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01)... | Howmedica Osteonics Corp | MBH | |
| Z-2889-2016 | Class II | ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or... | Ethicon, Inc | KDC |