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-1115-05 | Depuy LCS Complete RP insert; polyethylene tibial insert SM+, 12.5 mm; Ref 1294-05-212. | Depuy Orthopaedics Inc. | NJL | ||
| Z-1016-05 | Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro... | Ortho-Clinical Diagnostics, Inc. | KLT | ||
| Z-1015-05 | Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303 | Siemens Healthcare Diagnostics Inc. | DHX | ||
| Z-1114-05 | Depuy LCS Complete RP insert; polyethylene tibial insert SM+, 10 mm; Ref 1294-05-210. | Depuy Orthopaedics Inc. | NJL | ||
| Z-1058-05 | #309604 -- 10 mL syringe | Becton Dickinson & Co | FMF | ||
| Z-1057-05 | #309644 -- 10 ml syringe with 20 G1'' Needle | Becton Dickinson & Co | FMF | ||
| Z-1056-05 | #309661 -- Syringe only ll 20 mL | Becton Dickinson & Co | FMF | ||
| Z-1055-05 | # 309604 -- Syringe 10 mL LL | Becton Dickinson & Co | FMF | ||
| Z-1054-05 | # 309603 -- Syringe 5Ml LL syringe. | Becton Dickinson & Co | FMF | ||
| Z-0986-05 | Magnetic Resonance Imaging Systems; Visart, Excelart / Excelart P2 / Excelart P3 /... | Canon Medical Systems USA, Inc. | LNH | ||
| Z-1014-05 | Right Heart Catheter Product Line: Catalog Number 608055-------------827D1006I 4P BBM... | B Braun Medical Inc | DYG | ||
| Z-1013-05 | Right Heart Catheter Product Line: Catalog Number 608054------------827D1006I 4P BBM RMM... | B Braun Medical Inc | DYG | ||
| Z-1012-05 | Right Heart Catheter Product Line: Catalog Number 604315-------------406-1H-018... | B Braun Medical Inc | DYG | ||
| Z-1011-05 | Right Heart Catheter Product Line: Catalog Number 604264-------------427D1006I Round... | B Braun Medical Inc | DYG | ||
| Z-1010-05 | Right Heart Catheter Product Line: Catalog Number 604239-------------426D1009I. | B Braun Medical Inc | DYG | ||
| Z-1009-05 | Right Heart Catheter Product Line: Catalog Number 604165-------------T047-04 0427D1022I. | B Braun Medical Inc | DYG | ||
| Z-1045-05 | Mammomat Novation Digital Mammography System. Model number 6646900 | Siemens Medical Solutions USA, Inc. | |||
| Z-1008-05 | Right Heart Catheter Product Line: Catalog Number 604103-------------T047(97) 427D4036I. | B Braun Medical Inc | DYG | ||
| Z-1007-05 | Right Heart Catheter Product Line: Catalog Number 604100-----------T147-03 A427D1014... | B Braun Medical Inc | DYG | ||
| Z-1006-05 | Right Heart Catheter Product Line: Catalog Number 604057---------------T147 A427D1014KANI | B Braun Medical Inc | DYG | ||
| Z-1005-05 | Right Heart Catheter Product Line: Catalog Number 604037------T047-02 0427D10061. | B Braun Medical Inc | DYG | ||
| Z-1004-05 | Right Heart Catheter Product Line: Catalog Number 604028------------T047(90) 427D1022I. | B Braun Medical Inc | DYG | ||
| Z-1003-05 | Right Heart Catheter Product Line: Catalog Number 604025------------T046-02 0426D1009I... | B Braun Medical Inc | DYG | ||
| Z-1002-05 | Right Heart Catheter Product Line: Catalog Number 604000------417D1006I. | B Braun Medical Inc | DYG | ||
| Z-1001-05 | Right Heart Catheter Product Line: Catalog Number 601293------------WP1107S Monitory... | B Braun Medical Inc | DYG | ||
| Z-1000-05 | Right Heart Catheter Product Line: Catalog Number 601285-----WP11055 Wedge Press Cath. | B Braun Medical Inc | DYG | ||
| Z-0999-05 | Right Heart Catheter Product Line: Catalog Number 601276 ----WP1107 Wedge Press Cath. | B Braun Medical Inc | DYG | ||
| Z-0998-05 | Right Heart Catheter Product Line: Catalog Number 601272------WP1106 Wedge Press Cath. | B Braun Medical Inc | DYG | ||
| Z-0997-05 | Right Heart Catheter Product Line: Catalog Number 601261-----WP605P Wedge Press Cath. | B Braun Medical Inc | DYG | ||
| Z-0996-05 | Right Heart Catheter Product Line: Catalog Number 601258----WP604P Wedge Press Cath. | B Braun Medical Inc | DYG | ||
| Z-0995-05 | Right Heart Catheter Product Line: Catalog Number 601129-----5011094 0106 x 1007BBMWS. | B Braun Medical Inc | DYG | ||
| Z-1053-05 | BD Syringes - #309585 -- Piston Syringe, Syringe 3ML LL Syringe. | Becton Dickinson & Co | FMF | ||
| Z-1316-06 | Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality... | Radiometer America, Inc | GKF | ||
| Z-1428-2010 | Leksell SurgiPlan | Elekta Limited | HAW | ||
| Z-0982-05 | Aplio Diagnostic Ultrasound System (SSA-700A and SSA-770A) with software version 6.0er001... | Canon Medical Systems USA, Inc. | IYN | ||
| Z-0892-05 | Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V), 4506... | SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) | FTM | ||
| Z-0891-05 | Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V), 4506... | SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) | FTM | ||
| Z-0171-06 | Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P... | Provalis Diagnostics, Ltd. | LCP | ||
| Z-1061-05 | Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter). | Maquet Cardiovascular Us Sales, LLC | DWF | ||
| Z-1555-05 | Clinitron At Home Air Fluidized Therapy Bed | Hill-Rom Manufacturing, Inc. | FNL | ||
| Z-0937-05 | Potassium Electrode Tip; Part No.s: 668281 Tip Assembly- Synchron Family 669117 Packaged... | Siemens Healthcare Diagnostics Inc. | CEM | ||
| Z-0948-05 | Hill-Rom Century+ Bed, Model P1400. | Hill-Rom Inc. | FNL | ||
| Z-0915-05 | ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL... | Instrumentation Laboratory Co. | JPA | ||
| Z-0914-05 | LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233 | Magellan Diagnostics, Inc. | DOF | ||
| Z-0979-05 | ACCU-CHEK Instant Care Kit; Catalog number 91490. | Roche Diagnostics GmbH | CGA | ||
| Z-0977-05 | ACCU-CHEK Compact Care Kit; catalog number 3149137. | Roche Diagnostics GmbH | NBW | ||
| Z-0389-06 | Hospira brand Plum A+I.V. Infusion Pump, List No. 11971-04; Hospira brand Plum A+I.V... | Abbott Medical | FRN | ||
| Z-0978-05 | ACCU-CHEK Instant Meter; Catalog numbers 914 and 924. | Roche Diagnostics GmbH | CGA | ||
| Z-0976-05 | ACCU-CHEK Compact Meter; catalog number 3183572. | Roche Diagnostics GmbH | NBW | ||
| Z-0219-06 | Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is... | LeMaitre Vascular Inc. | DQT |