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-0998-2010 | Mycoplasma IgM ELISA 96 Well Kit, Catalog Number: MP021M The products in question are... | Calbiotech Inc | LJZ | ||
| Z-0997-2010 | Mycoplasma IgG ELISA 96 Well Kit, Catalog Number: MP020G, The products in question... | Calbiotech Inc | LJZ | ||
| Z-0996-2010 | H. Pylori IgM ELISA 96 Well Kit, Catalog Number: HP015M The products in question are... | Calbiotech Inc | LYR | ||
| Z-0995-2010 | H. Pylori IgA ELISA 96 Well Kit, Catalog Number: HP014A The products in question are... | Calbiotech Inc | LYR | ||
| Z-0994-2010 | EBV VCA IgM ELISA 96 Well Kit, Catalog Number: EV012M The products in question are all... | Calbiotech Inc | LSE | ||
| Z-0993-2010 | EBV VCA IgG ELISA 96 Well Kit, Catalog Number: EV010G The products in question are all... | Calbiotech Inc | LJZ | ||
| Z-0992-2010 | Dengue IgM ELISA 96 Well Kit, Catalog Number: DE051M The products in question are all... | Calbiotech Inc | NWY | ||
| Z-0991-2010 | Dengue IgG ELISA 96 Well Kit, Catalog Number: DE050G The products in question are... | Calbiotech Inc | NWY | ||
| Z-0990-2010 | dsDNA IgG ELISA 96 Well Kit, Catalog Number: DD037G The products in question are all... | Calbiotech Inc | LRM | ||
| Z-0989-2010 | Chlamydia Trachomatis IgA ELISA 96 Well Kit, Catalog Number: CT056A The products in... | Calbiotech Inc | MGM | ||
| Z-0988-2010 | Chlamydia Trachomatis IgM ELISA 96 Well Kit, Catalog Number: CT055M The products in... | Calbiotech Inc | MGM | ||
| Z-0987-2010 | Chlamydia Trachomatis IgG ELISA 96 Well Kit, Catalog Number: CT054G The products in... | Calbiotech Inc | MGM | ||
| Z-0986-2010 | Chlamydia Pneumoniae IgM ELISA 96 Well Kit, Catalog Number: CP095M The products in... | Calbiotech Inc | LJC | ||
| Z-0985-2010 | Chlamydia Pneumoniae IgG ELISA 96 Well Kit, Catalog Number: CP083G The products in... | Calbiotech Inc | LJC | ||
| Z-0984-2010 | Cardiolipin IgM ELISA 96 Well Kit, Catalog Number: CA036M The products in question are... | Calbiotech Inc | MID | ||
| Z-0983-2010 | Brucella IgM ELISA 96 Well Kit, Catalog Number: BA053M The products in question are... | Calbiotech Inc | GSM | ||
| Z-0982-2010 | Brucella IgG ELISA 96 Well Kit, Catalog Number: BA052G The products in question are... | Calbiotech Inc | GSM | ||
| Z-0981-2010 | ANA IgG ELISA 96 Well Kit, Catalog Number: AN033G The products in question are all... | Calbiotech Inc | LJM | ||
| Z-0272-2009 | Bone Marrow Aspiration Kit, consists of 3 main components packaged in a box. 1. Marrow... | Theken Companies LLC | KNW | ||
| Z-2473-2008 | Medtronic Attain ACCESS 6218A, Left-heart delivery system. Sterilized. Manufactured... | Medtronic, Inc. | DQY | ||
| Z-2472-2008 | Medtronic Attain LDS 6216A, Left-heart delivery system. Sterilized. Manufactured in... | Medtronic, Inc. | DQY | ||
| Z-2471-2008 | Medtronic Adjustable Valve, 6248VAL, Sterilized using irradiation. Medtronic, Inc... | Medtronic, Inc. | DTL | ||
| Z-0114-2009 | Safety Lancet for capillary blood sampling, 1.6 mm x 28G, Mini, Sarstedt. (Blood lancet) | Sarstedt ApS | FMK | ||
| Z-0119-2009 | Sonesta 6210 Fluoroscopy Procedure Table; a motorized procedure table with adjustments... | Stille AB | IXR | ||
| Z-1965-2009 | iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model... | Theken Companies LLC | MQV | ||
| Z-0228-2009 | Bag Tee Assembly Model P1407A . An accessory to the dental flowmeter which has a... | Precision Fluidics Division Parker Hannifin Corp. | CAX | ||
| Z-0592-2009 | Medtronic SynchroMed II Programmable Pump, Model 8637-40. 40 mL Reservoir. The contents... | Medtronic Neuromodulation | LKK | ||
| Z-0591-2009 | Medtronic SynchroMed II Programmable Pump, Model 8637-20. 20 mL Reservoir. The contents... | Medtronic Neuromodulation | LKK | ||
| Z-0590-2009 | Medtronic SynchroMed EL Programmable Pump, Model 8627L-18. 18 mL Reservoir. The... | Medtronic Neuromodulation | LKK | ||
| Z-0589-2009 | Medtronic SynchroMed EL Programmable Pump, Model 8627-18. 18 mL Reservoir. The contents... | Medtronic Neuromodulation | LKK | ||
| Z-0588-2009 | Medtronic SynchroMed EL Programmable Pump, Model 8627L-10. 10 mL Reservoir. The... | Medtronic Neuromodulation | LKK | ||
| Z-0587-2009 | Medtronic SynchroMed EL Programmable Pump, Model 8627-10. 10 mL Reservoir. The contents... | Medtronic Neuromodulation | LKK | ||
| Z-0586-2009 | Medtronic SynchroMed EL Programmable Pump, Model 8626L-18. 18 mL Reservoir. The... | Medtronic Neuromodulation | LKK | ||
| Z-0585-2009 | Medtronic SynchroMed EL Programmable Pump, Model 8626-18. 18 mL Reservoir. The contents... | Medtronic Neuromodulation | LKK | ||
| Z-0584-2009 | Medtronic SynchroMed EL Programmable Pump, Model 8626L-10. 10 mL Reservoir. The... | Medtronic Neuromodulation | LKK | ||
| Z-0583-2009 | Medtronic SynchroMed EL Programmable Pump, Model 8626-10. 10 mL Reservoir. The contents... | Medtronic Neuromodulation | LKK | ||
| Z-0317-2009 | AXIOM Artis System dMP using software version VB31D with 30x40 cm2 flat detectors. AXIOM... | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0316-2009 | AXIOM Artis System dTA using software version VB31D with 30x40 cm2 flat detectors. AXIOM... | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0315-2009 | AXIOM Artis System dTC using software version VB31D with 30x40 cm2 flat detectors. AXIOM... | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0314-2009 | AXIOM Artis System dFA using software version VB31D with 30x40 cm2 flat detectors. AXIOM... | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0313-2009 | AXIOM Artis System dBA using software version VB31D with 30x40 cm2 flat detectors. AXIOM... | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0312-2009 | AXIOM Artis System dFC using software version VB31D with 30x40 cm2 flat detectors. AXIOM... | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0163-2009 | Axiom Aristos FX Multipurpose Radiography System, stationary X-Ray system, Model number... | Siemens Medical Solutions USA, Inc. | KPR | ||
| Z-0031-2009 | Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene... | Boston Scientific Corporation | DQX | ||
| Z-0030-2009 | Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene... | Boston Scientific Corporation | DQX | ||
| Z-0306-2009 | CELL-DYN Sapphire Hematology Analyzer, List numbers 08H00-01, 08H00-03 A multi... | Abbott Medical | GKZ | ||
| Z-0172-2009 | AST R1 Reagent, 120 ml., Pointe Scientific, Inc., Canton, MI; Catalog no. 8-A7561-R1-120... | Horiba Instruments Incorporated | CIT | ||
| Z-0171-2009 | Liquid AST (SGOT) Reagent Set, Manufactured by Pointe Scientific, Inc., Canton, MI in 150... | Horiba Instruments Incorporated | CIT | ||
| Z-0482-2009 | ACE and ACE Alera Hemoglobin A1C : EZA1C Reagent, EZA1C Controls, and EZA1C... | Alfa Wassermann | LCP | ||
| Z-0160-2009 | WECK HemoClip Auto, Rx Only, Sterile, Teleflex Medical, RTC, NC 27709. The use of the... | Teleflex Medical | FZP |