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-0984-2011 | KING LT -D Laryngeal Tube, Size 2.5 KLTD2025, King Systems Corporation 15011 Herriman... | King Systems Corporation. | CAE | ||
| Z-0983-2011 | KING LT -D Laryngeal Tube, Size 2, KLTD202, King Systems Corporation 15011 Herriman... | King Systems Corporation. | CAE | ||
| Z-0982-2011 | Cardiac ResQ Kit, Size 5, CRQ425, King Systems Corporation 15011 Herriman Boulevard... | King Systems Corporation. | CAE | ||
| Z-0981-2011 | Cardiac ResQ Kit, Size 4, CRQ424, King Systems Corporation 15011 Herriman Boulevard... | King Systems Corporation. | CAE | ||
| Z-0980-2011 | Cardiac ResQ Kit , Size 3, CRQ423, Oropharyngeal Airway. King Systems Corporation 15011... | King Systems Corporation. | CAE | ||
| Z-0979-2011 | KING LTS -D, Size 5, 10-0027, Oropharyngeal Airway. King Systems Corporation 15011... | King Systems Corporation. | CAE | ||
| Z-0978-2011 | KING LTS -D, Size 4, 10-0026, Oropharyngeal Airway. King Systems Corporation 15011... | King Systems Corporation. | CAE | ||
| Z-0977-2011 | KING LTS -D, Size 3, 10-0025, Oropharyngeal Airway. King Systems Corporation, 15011... | King Systems Corporation. | CAE | ||
| Z-0976-2011 | KING LT-D Size 5, 10-0004, Oropharyngeal Airway. King Systems Corporation 15011 Herriman... | King Systems Corporation. | CAE | ||
| Z-0975-2011 | KING LT -D Size 4, 10-0003, Oropharyngeal Airway. King Systems Corporation 15011... | King Systems Corporation. | CAE | ||
| Z-0974-2011 | KING LT -D Size 3, 10-0002, Oropharyngeal Airway. King Systems Corporation 15011... | King Systems Corporation. | CAE | ||
| Z-1663-2011 | Rapid fFN for the TLi IQ system and specimen collection kit in the following... | Hologic, Inc. | LKV | ||
| Z-1662-2011 | Rapid fFN for the TLi IQ system and specimen collection kit in the following... | Hologic, Inc. | LKV | ||
| Z-1661-2011 | Rapid fFN for the TLi IQ system and specimen collection kit in the following... | Hologic, Inc. | lkv | ||
| Z-1660-2011 | Rapid fFN for the TLi IQ system and specimen collection kit in the following... | Hologic, Inc. | LKV | ||
| Z-1659-2011 | Rapid fFN for the TLi IQ system and specimen collection kit in the following... | Hologic, Inc. | LKV | ||
| Z-1658-2011 | Rapid fFN for the TLi IQ system and specimen collection kit in the following... | Hologic, Inc. | LKV | ||
| Z-1538-2010 | Percutaneous Sheath Introducer (PSI) Kit with Integral Hemostasis Valve/Side Port for use... | Arrow International LLC (subsidiary of Teleflex Incorporated) | KGZ | ||
| Z-0869-2010 | ONE SOURCE PACK, Model TK2S24, EE2S048 (OUS), Manufacturer: Medtronic, Inc., Minneapolis... | Medtronic, Inc. | KRI | ||
| Z-1070-2010 | Medtronic HMS PLUS, Hemostasis Management System, Model 30514. It is a microprocessor... | Medtronic, Inc. | JOX | ||
| Z-0868-2010 | IDEAL MAXPAC TOTAL SYSTEM (USA) , Sterile and Nonpyrogenic, ETO or Gamma Sterilized... | Medtronic, Inc. | KRI | ||
| Z-0041-2014 | Class II | Xoran MiniCAT CT Scanner ID ENT00001 | Xoran Technologies, LLC | JAK | |
| Z-2645-2011 | ERGO++ Stereotactic Radiation Treatment Planning System, ERGO++ Release 1.6.3 and... | Elekta Limited | MUJ | ||
| Z-0867-2011 | Stryker Digital Capture Pro 2 device (240-050-800, CD version) and (240-050-810, DVD... | Stryker Corp. | LMD | ||
| Z-0826-2010 | Encore Medical Foundation Knee Revision Baseplate, Part Number 321-01-106, Size 6, Left | Encore Medical, LP | JWH | ||
| Z-0611-2010 | Biomet 2.9 Micromax L-15 suture anchor, flexible long shaft, #2 blue/white maxbraid... | Zimmer GmbH | HWC | ||
| Z-0584-2010 | Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed... | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-0583-2010 | Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Siemens Medical... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-1883-2011 | Access Immunoassay Systems enhanced AccuTnl Reagent Kit, Part Number: A78803 The Access... | Siemens Healthcare Diagnostics Inc. | MMI | ||
| Z-0761-2010 | Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile... | Howmedica Osteonics Corp | JWH | ||
| Z-0760-2010 | Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile... | Howmedica Osteonics Corp | JWH | ||
| Z-0759-2010 | Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile... | Howmedica Osteonics Corp | JWH | ||
| Z-0758-2010 | Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile, Made... | Howmedica Osteonics Corp | JWH | ||
| Z-0757-2010 | Triathlon Total Stabilizer Femoral Component; Size # 2 for Use with TS Components... | Howmedica Osteonics Corp | JWH | ||
| Z-0645-2010 | GE Healthcare MAC 800 RESTING ECG ANALYSIS SYSTEM. The MAC 800 is a portable EGG... | GE Healthcare | DPS | ||
| Z-1787-2010 | Difco (TM) Decarboxylase Base Moeller, packaged in 500 gm bottles, labeled in part... | Becton Dickinson & Co | JSI | ||
| Z-1439-2010 | InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625... | Intervascular SAS | DSY | ||
| Z-1412-2010 | Varian Medical Systems, Eclipse Treatment Planning System, with v client versions 7.3... | Varian Medical Systems, Inc. | MUJ | ||
| Z-1427-2010 | InterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206... | Intervascular SAS | DSY | ||
| Z-1072-2010 | DeRoyal TOTAL HIP TRACECART, REF 53-1820.14, Rx ONLY, NON-STERILE. Custom surgical kit... | DeRoyal Industries, Inc. | LRO | ||
| Z-1071-2010 | DeRoyal TOTAL KNEE TRACECART, REF 53-1818.13, Rx ONLY, NON-STERILE. Custom surgical kit... | DeRoyal Industries, Inc. | LRO | ||
| Z-1680-2010 | UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. Beckman Coulter... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-1898-2011 | Device brochure, labeled in part : BIO -RAD***L70242709 VARIANT TM II TURBO***Hemoglobin... | Bio-Rad Laboratories Inc. | LCP | ||
| Z-0644-2010 | remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin, Ref R01626, 10/box. The firm... | Remel Inc | JTZ | ||
| Z-0977-2010 | Sigma-Aldrich Histopaque-1119, Ref. 11191, packaged in 100- ml. btls and 6x100-ml. btl... | Sigma-Aldrich Manufacturing, LLC | JCF | ||
| Z-0976-2010 | Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 100- and 500-ml. btls. and a... | Sigma-Aldrich Manufacturing, LLC | JCF | ||
| Z-3023-2011 | Access Immunoassay Systems UNCONJUGATED ESTRIOL Part # 33570 The Access Unconjugated... | Siemens Healthcare Diagnostics Inc. | CGI | ||
| Z-0343-2011 | Stratus(R) CS Rotors, catalog number CROTOR, lot number NH42-251-09 Intended use... | Siemens Healthcare Diagnostics Inc. | JHX | ||
| Z-0607-2010 | Medtronic Sofamor Danek Extended Length Trocar, Size : L=50MM, Item No.: 7578014... | Medtronic Sofamor Danek USA Inc | LXH | ||
| Z-0606-2010 | Medtronic Sofamor Danek Extended Length Trocar, Item No.: 7578013, Mat'l: Stainless... | Medtronic Sofamor Danek USA Inc | LXH |