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-1114-2014 | Class II | PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3... | Champion Mfg, Inc. | INM | |
| Z-0098-2014 | Class II | Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial... | Small Bone Innovations, Inc. | KWI | |
| Z-0087-2014 | Class II | chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation... | bioMerieux, Inc. | ||
| Z-2280-2013 | Class III | ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many... | Horiba Instruments Incorporated | CIC | |
| Z-2301-2013 | Class II | Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The... | Hologic, Inc. | MUE | |
| Z-0030-2014 | Class II | Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The... | Revvity Health Sciences, Inc. | JKA | |
| Z-2273-2013 | Class I | Product Name: AVEA Ventilator. All Models. The affected devices are cleared under... | Jaeger Medical GmbH | CBK | |
| Z-0178-2014 | Class II | Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human... | VitalScientific | CJY | |
| Z-2318-2013 | Class II | McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product... | Mckesson Information Solutions, LLC | LLZ | |
| Z-0099-2014 | Class II | Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer... | Baxter Healthcare Corporation | FPA | |
| Z-2260-2013 | Class II | Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The... | Integra Pain Management | HGB | |
| Z-0089-2014 | Class II | BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT)... | Philips North America LLC | KPS | |
| Z-0140-2014 | Class II | Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version... | Siemens Medical Solutions USA, Inc. | JAA | |
| Z-0346-2014 | Class II | ADVIA 2400 System Software V4.01. Performs assays for general and specialty chemistries... | Siemens Healthcare Diagnostics Inc. | JGS | |
| Z-0345-2014 | Class II | ADVIA 1800 System Software V2.01. Performs assays for general and specialty chemistries... | Siemens Healthcare Diagnostics Inc. | JGS | |
| Z-0344-2014 | Class II | ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for general and... | Siemens Healthcare Diagnostics Inc. | JGS | |
| Z-0374-2014 | Class II | (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia... | Siemens Medical Solutions USA, Inc. | KPR | |
| Z-0343-2014 | Class II | ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and... | Siemens Healthcare Diagnostics Inc. | JGS | |
| Z-2255-2013 | Class III | King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in... | King Systems Corporation. | CAE | |
| Z-2209-2013 | Class II | Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller... | Gentherm Medical, LLC | DWJ | |
| Z-2486-2015 | Class II | Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician... | Physician Engineered Products, Inc. | LBI | |
| Z-0167-2014 | Class II | Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower and toilet... | Invacare GmbH | INN | |
| Z-0013-2014 | Class II | Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16... | Philips North America LLC | JAK | |
| Z-0012-2014 | Class II | GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use... | GE Healthcare | JAA | |
| Z-0181-2014 | Class II | Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay | Siemens Healthcare Diagnostics Inc. | DLZ | |
| Z-0109-2014 | Class II | Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an... | Baxter Healthcare Corporation | FPA | |
| Z-0080-2014 | Class II | NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States) | Zimmer GmbH | NJL | |
| Z-2271-2013 | Class II | Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products... | Stryker Corp. | BZN | |
| Z-2211-2013 | Class II | Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or... | Implantech Associates Inc | FWP | |
| Z-2281-2013 | Class II | CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to... | CareFusion 303, Inc | FPA | |
| Z-2285-2013 | Class II | SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set. | CareFusion 303, Inc | FPA | |
| Z-2279-2013 | Class II | SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing Infusion Sets... | CareFusion 303, Inc | FPA | |
| Z-0079-2014 | Class II | Sidus" Head (Not distributed in the United States) | Zimmer GmbH | JWH | |
| Z-0078-2014 | Class II | Natural-Knee II Femoral Component | Zimmer GmbH | JWH | |
| Z-0077-2014 | Class II | Gender Solutions" Patello-Femoral Component | Zimmer GmbH | KRR | |
| Z-0076-2014 | Class II | Zimmer Unicompartmental Knee Femoral Component. Indicated for patients with painful... | Zimmer GmbH | HSX | |
| Z-0075-2014 | Class II | Natural-Knee Flex Femoral Component. Provides increased flexion capability. | Zimmer GmbH | JWH | |
| Z-0074-2014 | Class II | NexGen Femoral Component (CR-FLEX GSF POR FEM, C-L; CR-FLEX GSF POR FEM, C-R; CR-FLEX GSF... | Zimmer GmbH | JWH | |
| Z-0073-2014 | Class II | NexGen Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOAT SZ C-R... | Zimmer GmbH | JWH | |
| Z-0072-2014 | Class II | CoCr Head (Not distributed in the United States) Used in total hip replacement. | Zimmer GmbH | LPH | |
| Z-0071-2014 | Class II | Metasul Head. Intended for use either with or without bone cement in total hip... | Zimmer GmbH | KWA | |
| Z-0070-2014 | Class II | Versys Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM; VERSYS BEADED FC... | Zimmer GmbH | LPH | |
| Z-0069-2014 | Class II | CPT Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT 12/14 STEM... | Zimmer GmbH | JDI | |
| Z-0068-2014 | Class II | Multipolar Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture... | Zimmer GmbH | KWY | |
| Z-1458-2014 | Class II | BIOMET 3i Endosseous Dental Implant. | ZimVie US Corp LLC | DZE | |
| Z-0491-2014 | Class II | Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc... | Eastman Kodak Company | IZL | |
| Z-0210-2014 | Class II | Composite Series Skull Clamp, one clamp per tote. The MAYFIELD Skull Clamp (A3059) is a... | Integra LifeSciences Corporation | HBL | |
| Z-0733-2014 | Class II | Consult Diagnostics Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the... | ELITechGroup Inc | CJY | |
| Z-2263-2013 | Class II | Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road... | STERIS Corporation | NZA | |
| Z-0732-2014 | Class II | Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the... | ELITechGroup Inc | CJY |