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-1684-2011 | SCORPIO-FLEX CR TIBIAL TRIAL, non sterile, made in the USA Howmedica Osteonics Corp... | Howmedica Osteonics Corp | LXH | ||
| Z-1683-2011 | SCORPIO-FLEX PS TIBIAL TRIAL, non sterile, made in the USA Howmedica Osteonics Corp... | Howmedica Osteonics Corp | LXH | ||
| Z-1682-2011 | SCORPIO PS TIBIAL TRIAL, non sterile, made in the USA Howmedica Osteonics Corp., 325... | Howmedica Osteonics Corp | LXH | ||
| Z-1681-2011 | SCORPIO CR TIBIAL TRIAL, non sterile, made in the USA Howmedica Osteonics Corp., 325... | Howmedica Osteonics Corp | JWH | ||
| Z-2401-2010 | Maquet HLM Tubing Pack; Bioline Coating | Maquet Cardiovascular Us Sales, LLC | DWE | ||
| Z-2233-2010 | AXIOM Artis MP/Artis dMP and Artis zee Multipurpose. Angiographic x-ray system. | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0006-2011 | CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model... | CareFusion 303, Inc | FRN | ||
| Z-2222-2010 | SIEMENS AXIOM Luminos TF and Sireskop SD Solid State x-ray imager (flat panel/digital... | Siemens Medical Solutions USA, Inc. | MQB | ||
| Z-2310-2010 | Genzyme Biosurgery Essentials Kit, Item Number 82004 | Genzyme Corporation | LRO | ||
| Z-2623-2010 | Strattice Reconstructive Tissue Matrix for Stoma Reinforcement. 8 cm x 8 cm Packaged in... | LifeCell Corp | FTM | ||
| Z-2636-2010 | Glenoid Head Inserter (RSP Inserter/Impactor), Device Part #804-03-041, All Lots. Product... | Encore Medical, LP | LXH | ||
| Z-0438-2011 | The Ascension PyroHemiSphere (aka NuGrip), Model #40-M NUG-443-40M, Catalog #NUG-443-40M... | Ascension Orthopedics, Inc. | KYI | ||
| Z-0437-2011 | The Ascension PyroHemiSphere (aka NuGrip), Model #30-L NUG-443-30L, Catalog #NUG-443-30L... | Ascension Orthopedics, Inc. | KYI | ||
| Z-0977-2012 | AU Clinical Chemistry Analyzers: Model Number: AU5400 Clinical Chemistry Analyzer. The... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0976-2012 | AU Clinical Chemistry Analyzers: Model Number: AU2700 Clinical Chemistry Analyzer . The... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0975-2012 | AU Clinical Chemistry Analyzers: Model Number: AU600 Clinical Chemistry Analyzer, AU640... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0974-2012 | AU Clinical Chemistry Analyzers: Model Number: AU400 Clinical Chemistry... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-2635-2010 | Enseal TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05 | Ethicon Endo-Surgery Inc | NLM | ||
| Z-2609-2010 | Engenex Non Acute Care Suction Pump for use with Engenex Negative Pressure Wound Therapy | ConvaTec Limited | OMP | ||
| Z-2108-2010 | GEM Check Coag CNTRL Abnormal APTT Whole Blood Controls Package Insert; IVD... | Accriva Diagnostics, Inc. | GGN | ||
| Z-2107-2010 | GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert: IVD. 15/pk... | Accriva Diagnostics, Inc. | GGN | ||
| Z-0413-2011 | Detachol adhesive remover, 4 fl oz (118 mL), Marketed by Eloquest Healthcare, Inc., a... | Ferndale Laboratories, Inc. | KOX | ||
| Z-2686-2011 | Beckman Coulter UniCel DxI 600 Access Immunoassay System with Unicel DXI system software... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-2685-2011 | Beckman Coulter UniCel DxI 800 Access Immunoassay System with Unicel DXI system software... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0890-2011 | CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery... | Accuray Incorporated | MUJ | ||
| Z-2641-2010 | PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers, 15 tests 1... | Polymer Technology Systems | NBW | ||
| Z-2192-2010 | REF 87100 87k Arthroscopy Tubing Set. For use with the 87k Arthroscopy Pump (87000)... | Linvatec Corporation | HRX | ||
| Z-2440-2010 | TRABECULAR METAL FEMORAL CONE AUGMENT - RIGHT, Part Number: 00-5450-012-32. The... | Zimmer GmbH | JWH | ||
| Z-2439-2010 | TRABECULAR METAL FEMORAL CONE AUGMENT - LEFT, Part Number: 00-5450-012-31. The... | Zimmer GmbH | JWH | ||
| Z-2291-2010 | VERSYS HIP SYSTEM FEMORAL HEAD 12/14 TAPER 28 MM DIA. -3.5 MM NECK LENGTH ZIMALOY... | Zimmer GmbH | LPH | ||
| Z-2290-2010 | VERSYS HIP SYSTEM FEMORAL HEAD 12/14 TAPER 32 MM DIA. -3.5 MM NECK LENGTH ZIMALOY... | Zimmer GmbH | LPH | ||
| Z-2289-2010 | Zimmer ITST" INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION LOCKING BOLT EXTRACTOR... | Zimmer GmbH | LXH | ||
| Z-2382-2010 | Impella 5.0 Circulatory Support System Catalog number: 004840 The Impella 5.0 System is... | Abiomed, Inc. | KFM | ||
| Z-0025-2011 | Tru-Core II Disposable Automatic Biopsy Instrument and Tru-Core II URO Disposable... | Medical Device Technologies, Inc. | MJG | ||
| Z-2294-2010 | Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002... | Greatbatch Medical | DYB | ||
| Z-2235-2010 | medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with Pre-Attached... | Medical Components, Inc. | LJT | ||
| Z-0823-2011 | Steris Reliance EPS Endoscope Processing System , manufactured by Corporation STERIS... | STERIS Corporation | MLR | ||
| Z-2205-2010 | Pulmonetic Systems P/N 19189-001 Patient Circuit SPU W/O PEEP 15 FT 5/Pkg. These circuits... | Pulmonetic Systems, Inc. | CBK | ||
| Z-2425-2010 | Integra NeuroSciences Implants, NeuroBalloon Catheter, Sterile/EO, Rx only, single use... | Integra LifeSciences Corporation | HAO | ||
| Z-0457-2011 | Respironics V60 Ventilator, manufactured by Respironics California Inc. in Carlsbad, CA. | Respironics, Inc. | MNT | ||
| Z-2234-2010 | Hospira Accessory Power Pack; a 4 outlet power strip with a custom pole clamp bracket to... | Abbott Medical | FRN | ||
| Z-0101-2011 | NOVAPLUS (TM), SUCTION CANISTER, 1200cc, RIGID, WITH ELBOW, Cat. No. V71-3001, Rx only... | DeRoyal Industries, Inc. | KDQ | ||
| Z-2605-2010 | 8 MM DISPOSABLE CORING TREPHINE STAGGERED TEETH WITH PROTECTION SLEEVE, REF 900788... | Zimmer GmbH | LXH | ||
| Z-2604-2010 | 10 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900740, Sterile, BIOMET... | Zimmer GmbH | LXH | ||
| Z-2603-2010 | 9 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900739, Sterile, BIOMET... | Zimmer GmbH | LXH | ||
| Z-2602-2010 | 8 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900738, Sterile, BIOMET... | Zimmer GmbH | LXH | ||
| Z-2601-2010 | 7 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900737, Sterile, BIOMET... | Zimmer GmbH | LXH | ||
| Z-2600-2010 | 10 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900730, Sterile, BIOMET... | Zimmer GmbH | LXH | ||
| Z-2599-2010 | 9 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900729, Sterile, BIOMET... | Zimmer GmbH | LXH | ||
| Z-2598-2010 | 8 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900728, Sterile, BIOMET... | Zimmer GmbH | LXH |