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-1284-2010 | NIC02 Model 7600 Demo Unit, Respironics/Philips product. Intended use is cardiac... | Philips North America LLC | CCK | ||
| Z-1283-2010 | Tidal Wave Model 615, Respironics/Philips product. Intended use of the monitors is to... | Philips North America LLC | CCK | ||
| Z-1282-2010 | Spanish 100-120V NICO 7300, Respironics/Philips product. Intended use is cardiac... | Philips North America LLC | CCK | ||
| Z-1281-2010 | French 100-120V NICO 7300, Respironics/Philips product. Intended use is: cardiac... | Philips North America LLC | CCK | ||
| Z-1280-2010 | 100-120V NICO, 7300 Cardio Mgt system, Respironics/Philips product. Intended use is... | Philips North America LLC | CCK | ||
| Z-1279-2010 | Japanese TidalWave SP 715, Respironics/Philips product. Intended use of the monitors... | Philips North America LLC | DQA | ||
| Z-1278-2010 | Tidal Wave Sp Model 715, Respironics/Philips product. Intended use of the monitors is... | Philips North America LLC | DQA | ||
| Z-1277-2010 | Japanese TidalWave SP 710, Respironics/Philips product. Intended use of the monitors... | Philips North America LLC | DQA | ||
| Z-1276-2010 | TidalWave SP 710, Respironics/Philips product. Intended use of the monitors is to... | Philips North America LLC | DQA | ||
| Z-1275-2010 | Spanish 100-120V Cosmo Plus 8100, Respironics/Philips product. Used to provide... | Philips North America LLC | BZC | ||
| Z-1274-2010 | Resp Profile Monitor, 8100 Cosmo+, Respironics/Philips product. Used to provide... | Philips North America LLC | BZC | ||
| Z-1273-2010 | Tidal wave, Model 610, Respironics/Philips product. Intended use of the monitors is to... | Philips North America LLC | CCK | ||
| Z-1272-2010 | Spanish 100-120V TCOM-860, Respironics/Philips product. Used for trending O2 and CO2... | Philips North America LLC | LKD | ||
| Z-1271-2010 | French 100-120V 860 TC C02 & 02 Monitor, Respironics/Philips product. Used for... | Philips North America LLC | LKD | ||
| Z-1270-2010 | Transcutaneous C02 & O2 Monitor - 860, Respironics/Philips product. Used for trending... | Philips North America LLC | LKD | ||
| Z-1269-2010 | Spanish 100-120V Cosmo - 7100 Capnograp, Respironics/Philips products. Intended to be... | Philips North America LLC | DQA | ||
| Z-1268-2010 | Cosmo - Model 7100 SP02 & ETC02 Monitor, Respironics./Philips product. Intended to be... | Philips North America LLC | DQA | ||
| Z-1267-2010 | Spanish Capnogard 1265, Respironics/Philips product. Intended to be used for... | Philips North America LLC | CCK | ||
| Z-1266-2010 | 100-120V Capnogard 1265, Respironics/Philips product. Intended to be used for... | Philips North America LLC | CCK | ||
| Z-1265-2010 | Evaluation Kit, LOFLO Engine, Respironics/Philips product. Intended use of the LoFlo C5... | Philips North America LLC | CCK | ||
| Z-1264-2010 | C5 LOFLO Evaluation Kit, Respironics/Philips product. Intended use of the LoFlo C5 CO2... | Philips North America LLC | CCK | ||
| Z-1263-2010 | Sharn TidalGuard SP 710V, Respironics/Philips product. Intended use of the monitors is... | Philips North America LLC | DQA | ||
| Z-1262-2010 | NICO2, Model 7600 Respironics/Philips Product. Intended use is cardiac output... | Philips North America LLC | CCK | ||
| Z-1261-2010 | Evaluation Kit, Capnostat 5, Respironics/Philips Product. Intended use of the Capnostat... | Philips North America LLC | CCK | ||
| Z-1260-2010 | DeviceLink Connectivity Hardware. Supports Philips specified manufacturers' devices... | Philips North America LLC | MWI | ||
| Z-1259-2010 | HeartStart MRx- AC power module kit. For use for the termination of ventricular... | Philips North America LLC | MKJ | ||
| Z-1258-2010 | HeartStart MRx Defibrillator/Monitor. For use for the termination of ventricular... | Philips North America LLC | MKJ | ||
| Z-0641-2010 | Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case. Case contents... | Orthofix SRL | MQP | ||
| Z-0591-2010 | Bausch & Lomb SoFlex SE Foldable Intraocular Lens. UPC 4001404, Rx Only... | Bausch & Lomb Incorporated | HQL | ||
| Z-1257-2010 | AC power cords manufactured by Electri-Cord with tall bridge design. Used across all... | Philips North America LLC | MKJ | ||
| Z-0251-2013 | Class II | Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface... | CliniSys, Inc | JQP | |
| Z-2369-2012 | Class II | CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based... | Biosense Webster Inc | DQK | |
| Z-0589-2010 | Maquet Servo Ventilator SV900C/D/E (SV900) Siemens-Elema AB, Solna, Sweden | Maquet Cardiovascular Us Sales, LLC | CBK | ||
| Z-0588-2010 | Maquet Servo Ventilator 300/300A (SV300) Siemens - Elema AB, | Maquet Cardiovascular Us Sales, LLC | CBK | ||
| Z-0591-2011 | CHROMOPHARE Surgical Lighting System & CHROMOVIEW Flat Panel Monitor, Mechanical Spring... | Berchtold Corp. | FTD | ||
| Z-0548-2010 | Hill-Rom Affinity Four Birthing Bed, Hill-Rom Company, Inc., Batesville, Indiana; Model... | Hill-Rom Inc. | HDD | ||
| Z-0651-2010 | Smiths Medical Medfusion model 3010a syringe Infusion pump. REF 3010A. Rx Only. Smiths... | Abbott Medical | FRN | ||
| Z-0650-2010 | Smiths Medical Medfusion model 3500 syringe Infusion pump, software version V3.0.6... | Abbott Medical | FRN | ||
| Z-1064-2010 | Zimmer NexGen Complete Knee Solution Minimally Invasive Solutions Procedures Trabecular... | Zimmer GmbH | JWH | ||
| Z-0906-2010 | Pointe Scientific Iron Reagent (R2), for the quantitative determination of serum iron... | Horiba Instruments Incorporated | JIY | ||
| Z-0905-2010 | Pointe Scientific, Inc. Iron Color Reagent, Pointe Scientific, Inc., Canton, MI., Catalog... | Horiba Instruments Incorporated | JIY | ||
| Z-0904-2010 | Pointe Scientific, Inc. Iron Buffer Reagent, Pointe Scientific, Inc., Canton, MI... | Horiba Instruments Incorporated | JIY | ||
| Z-0903-2010 | Pointe Scientific Iron (Ferrozine) R2 Reagent Set, for the quantitative determination of... | Horiba Instruments Incorporated | JIY | ||
| Z-0902-2010 | Pointe Scientific Iron (Ferrozine) R1 Reagent Set, for the quantitative determination of... | Horiba Instruments Incorporated | JIY | ||
| Z-0901-2010 | Pointe Scientific Iron (Ferrozine) Reagent Set, for the quantitative determination of... | Horiba Instruments Incorporated | JIY | ||
| Z-0900-2010 | Pointe Scientific Total Iron Reagent Set, for the quantitative determination of serum... | Horiba Instruments Incorporated | JIY | ||
| Z-0899-2010 | Pointe Scientific Iron/TIBC Reagent Set, for the quantitative determination of serum iron... | Horiba Instruments Incorporated | JIY | ||
| Z-1155-2010 | Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo... | Abaxis Inc | JFY | ||
| Z-0563-2010 | AquaStar Water Caloric Irrigator; water caloric stimulator; Manufactured for/Distributed... | Micromedical Technologies, Inc. | ETP | ||
| Z-1537-2012 | HemaSyst, Dual Cannula Tip with Adapter 16 ga. x 4" (10.2 cm). Product is labeled in... | Haemacure Corp. | KYZ |