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-2752-2011 | Abbott CELL-DYN 1700 Analyzer, CELL-DYN 1700 CS (Closed Sample).Manufactured by Abbott... | Abbott Medical | GKZ | ||
| Z-1902-2011 | Abbott CELL-DYN 3000CS (Closed Sampler), CELL-DYN 3000SL (Sample Loader). Manufactured by... | Abbott Medical | GKZ | ||
| Z-1069-2011 | FlexTray Procedure Delivery System, Product Codes: KBW71SXL- Bariatric Surgery Trays... | Ethicon Endo-Surgery Inc | LRP | ||
| Z-1068-2011 | ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Product Codes: ATS45... | Ethicon Endo-Surgery Inc | GEI | ||
| Z-1703-2011 | Abbott CELL-DYN 3500 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3500 SL (Sample... | Abbott Medical | GKZ | ||
| Z-1702-2011 | Abbott CELL-DYN 3200 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3200 SL (Sample... | Abbott Medical | GKZ | ||
| Z-1701-2011 | Abbott CELL-DYN 3700 Hematology Analyzer CS (Closed Sampler), , and CELL-DYN 3700 SL... | Abbott Medical | GKZ | ||
| Z-1434-2009 | ADDitIV Primary IV Set with Universal Spike, Backcheck Valve, two Injection Sites and... | B Braun Medical Inc | FPA | ||
| Z-1433-2009 | Ultrasite ADDitIV Primary IV Set with Universal Spike, Backcheck Valve, two Ultrasite... | B Braun Medical Inc | FPA | ||
| Z-1432-2009 | Anesthesia IV Set with Universal Spike, Backcheck Valve, two Ultrasite Injection Sites... | B Braun Medical Inc | FPA | ||
| Z-1431-2009 | Outlook Safety Infusion System IV Set with Universal Spike, Backcheck Valve, Ultrasite... | B Braun Medical Inc | FPA | ||
| Z-1430-2009 | Ultrasite IV Administration Set with Universal Spike, three Backcheck Valves, three... | B Braun Medical Inc | FPA | ||
| Z-1429-2009 | Primary IV Set with Universal Spike, Backcheck Valve, 3 Ultrasite Injection Sites and... | B Braun Medical Inc | FPA | ||
| Z-1428-2009 | Ultrasite IV Set for Outlook Safety Infusion System with Universal Spike, Pressure... | B Braun Medical Inc | FPA | ||
| Z-1427-2009 | IV Administration Set with Universal Spike, two Ultrasite Injection Sites, Backcheck... | B Braun Medical Inc | FPA | ||
| Z-2011-2009 | Post Medical Valves VO870A-Y and VO870-A-Y-T PSI 2015, PSI 2015, CGA 870, Inlet .750... | Intermed Gas Products Corporation | ECX | ||
| Z-2116-2009 | Uniflex Ti Buttress Thread Screw; TI Screw Buttress Thread Trauma Fixation Systems, Rx... | Ebi, LLC | HSB | ||
| Z-2115-2009 | Phoenix Cannulated Recon Screw; Ti-Cann PARTL THD Recon Screw Trauma Fixation... | Ebi, LLC | HSB | ||
| Z-1432-2012 | SYNCHRON Ammonia (AMM) Reagent Product Usage: AMM reagent, when used in conjunction with... | Siemens Healthcare Diagnostics Inc. | JIF | ||
| Z-1882-2009 | MR Coaxial 10g x 118mm (VC10118MR). | Bard Peripheral Vascular Inc | DWF | ||
| Z-1881-2009 | MR Coaxial 10g x 140mm (VC10140MR). | Bard Peripheral Vascular Inc | DWF | ||
| Z-1880-2009 | Plastic Radiolucent Coaxial for 10g x 140mm (VC10140P). | Bard Peripheral Vascular Inc | DWF | ||
| Z-1879-2009 | Plastic Radiolucent Coaxial for 10gx118 (Catalog VC10118P). | Bard Peripheral Vascular Inc | DWF | ||
| Z-1015-2010 | Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on... | Radiometer America, Inc | CGL | ||
| Z-1473-2009 | Arrow Embolectomy Catheters: 4 French, 2 Lumen x 40cm, Product Number: W01798, Single... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DXE | ||
| Z-1472-2009 | Arrow Embolectomy Catheters: 5 French, 2 Lumen x 80cm, Product Number: W01801, Single... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DXE | ||
| Z-1471-2009 | Arrow Embolectomy Catheters: 5 French, 2 Lumen x 40cm, Product Number: W01800, Single... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DXE | ||
| Z-1808-2009 | American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for... | Tenex Health | HQC | ||
| Z-1694-2009 | Capless Li Pedicle Screw System, Diameters - 4.75mm, 5.5mm, 6.5mm, 7.5mm, 8.25mm, Lengths... | Xtant Medical Holdings, Inc. | MNH | ||
| Z-1118-2009 | Definium 5000 X-ray System, model number 5220493 and 5220393-2 | GE Healthcare | KPR | ||
| Z-1543-2009 | GE Centricity PACS RA1000 Workstation software (for diagnostic image analysis); GE... | GE Healthcare | LLZ | ||
| Z-1214-2010 | Medtronic N'Vision 8870 Application Card for use in the Medtronic model 8840 Physician... | Medtronic Neuromodulation | LKK | ||
| Z-2008-2009 | Model 100 enFlow Fluid/Blood Warmer Model Numbers: 980100, 91000103, 91000153... | Enginivity, LLC | LGZ | ||
| Z-1389-2012 | Pharmacy compounding system . It is a twenty-four source compounder for multi-source... | Baxter Corporation Englewood | NEP | ||
| Z-1552-2009 | Medtronic Ideal MAXPAC Total System, Catalog Numbers: TS1262R6, TS1262R7, TS1420R... | Medtronic Perfusion Systems | OEU | ||
| Z-1551-2009 | Medtronic One Source Pack Magellan, Catalog Number: COS310. Kits are packaging... | Medtronic Perfusion Systems | OEU | ||
| Z-1550-2009 | Medtronic One Source Pack, Catalog Numbers: ATLS21, ATLS24, ATLS2469, EC1S24, EC2S00... | Medtronic Perfusion Systems | OEU | ||
| Z-1679-2009 | Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the... | Boston Scientific Corporation | LWP | ||
| Z-1678-2009 | Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models... | Boston Scientific Corporation | LWP | ||
| Z-1261-2009 | Zimmer Sirus Intramedullary nail for tibia, cannulated, diameter 12 L, 330 mm, sterile... | Zimmer GmbH | HSB | ||
| Z-1422-2009 | EP-4 Computerized Cardiac Stimulator; SJM Part Numbers: 09-1527-0000 / 09-1527-0002; EP... | Abbott Medical | JOQ | ||
| Z-1252-2009 | Servo Ventilator 300 (Model SV300) and Servo Ventilator 300 (Model SV300A). The SV300... | Maquet Cardiovascular Us Sales, LLC | CBK | ||
| Z-1961-2011 | Auxiliary 2 MHz Continuous Wave (CW) transducer, model number 8251046, when used with... | Siemens Medical Solutions USA, Inc. | ITX | ||
| Z-0620-2011 | Spacelabs Medical Flat Panel Display is a touchscreen display, 19-inch thin film... | GE Healthcare | DXJ | ||
| Z-1745-2011 | Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using... | Siemens Medical Solutions USA, Inc. | DQO | ||
| Z-1323-2009 | Lactosorb Pectus Stabilizer, model number: 01-3805. Distributed and Manufactured by... | Biomet Microfixation | HRS | ||
| Z-1234-2009 | Dentsply, MAILLEFER, CYTCO-K TITANIUM POST SYSTEM, dental implant components, Model... | Dentsply Sirona Inc | ELR | ||
| Z-1153-2010 | Xact 10 mm x 20 mm x 136 cm (Part Number 82099-01) The Xact Carotid Stent System, used... | Abbott Vascular | NIM | ||
| Z-1152-2010 | Xact 9 mm x 20 mm x 136 cm (Part Number 82089-01) The Xact Carotid Stent System, used... | Abbott Vascular | NIM | ||
| Z-1229-2010 | 5mm Tibial Augment Block, a component of Ortho Balanced Knee Modular Tibial... | Ortho Development Corp. | JWH |