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-0699-06 | Osteofil Allograft, 5cc. Product is labeled in part: ''***Processed at: Regeneration... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0698-06 | Osteofil + RT Allograft Paste 10cc. Product is labeled in part: ''***Processed at... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0501-06 | Product is 2.0 cc Opteform RT. Product is labeled in part: ''***Processed at... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0500-06 | Product is OPTEFORM Allograft Full Disc, 5 x 90mm, 32cc, Frozen. Product is labeled in... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0499-06 | Product is OPTEFIL Allograft Paste, Syringe of varying sizes. Product is labeled in... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0498-06 | Product is OPTEFIL Allograft Paste of varying sizes. Product is labeled in part... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0497-06 | Product is 1.0cc flowable paste from donor approved for distribution in Italy. Product... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0496-06 | Product is REGENAFIL Allograft Paste, Syringe, 0.5cc. Product is labeled in part... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0495-06 | Product is RTI Allograft Paste of varying sizes. Product is labeled in part... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0494-06 | Product is REGENAFORM Allograft Moldable Blocks, of varying sizes. Product is labeled in... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0493-06 | Product is REGENAFORM RT Allograft Paste, 1cc. Product is labeled in part... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0492-06 | Product is Regenafil IC. Product is labeled in part: ''***Processed at: Regeneration... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0491-06 | OsteoPack 3 FZ 22cc. Product is labeled in part: ''***Processed at: Regeneration... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0490-06 | OSTEOFIL DBM Paste of varying sizes. Product is labeled in part: ''***Processed at... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0489-06 | Osteofil RT, ICM Allograft Paste of varying sizes. Product is labeled in part... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0488-06 | Osteofil ICM Moldable Strip of varying sizes. Product is labeled in part... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0487-06 | Osteofil IC Syringeable of varying sizes. Product is labeled in part: ''***Processed... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0486-06 | Osteofil Allograft Paste (Bio) of varying sizes. Product is labeled in part... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0485-06 | Osteofil + RT Allograft Paste in varying sizes. Product is labeled in part... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0484-06 | OPTEFORM RT Moldable Allograft of varying sizes. Product is labeled in part... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0483-06 | Product is OPTEFORM Allograft Paste of varying sizes. Product is labeled in part... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0482-06 | Product is OPTEFORM Allografts of varying sizes. Product is labeled in part... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0481-06 | Product is 1.0 cc Regenaform RT. Product is labeled in part: ''***Processed at... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0320-06 | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is... | Agilent Technologies, Inc. | NJT | ||
| Z-0319-06 | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is... | Agilent Technologies, Inc. | NJT | ||
| Z-0318-06 | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is... | Agilent Technologies, Inc. | NJT | ||
| Z-0317-06 | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is... | Agilent Technologies, Inc. | NJT | ||
| Z-0316-06 | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is... | Agilent Technologies, Inc. | NJT | ||
| Z-0315-06 | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is... | Agilent Technologies, Inc. | NJT | ||
| Z-0314-06 | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is... | Agilent Technologies, Inc. | NJT | ||
| Z-0313-06 | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is... | Agilent Technologies, Inc. | NJT | ||
| Z-0312--06 | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is... | Agilent Technologies, Inc. | NJT | ||
| Z-0311-06 | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is... | Agilent Technologies, Inc. | NJT | ||
| Z-0310-06 | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is... | Agilent Technologies, Inc. | NJT | ||
| Z-0196-06 | Analogic SyneRad Multi Digital Radiology System, Model AN6150 | Analogic Corp. | KPR | ||
| Z-0427-06 | Flexible Support Arm Assembly. Breathing Tube Support. Catalog number BE 122-30 | Instrumentation Industries, Incorporated | JAY | ||
| Z-0360-06 | Vapotherm" Respiratory Gas Humidifier, Model 2000i, labeled in part ***Vapotherm Inc... | Vapotherm Inc. | BTT | ||
| Z-0115-06 | BirthNet OB Data Management System 91861 | GE Healthcare | HGM | ||
| Z-0209-06 | AD6 table, modified, used with the XPER systems. The modification on the table is the... | Philips North America LLC | IZI | ||
| Z-0208-06 | AD5 table, modified, used with the XPER x-ray systems. The modification on the table is... | Philips North America LLC | IZI | ||
| Z-0281-06 | Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation... | Canon Medical Systems USA, Inc. | LNH | ||
| Z-0173-06 | VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical... | Ortho-Clinical Diagnostics, Inc. | LEH | ||
| Z-0207-06 | AD6 table for use with Integris and Integris Allura x-ray systems. The AD6 is the tilt... | Philips North America LLC | IZI | ||
| Z-0206-06 | AD5 table for use with Integris and Integris Allura x-ray systems | Philips North America LLC | IZI | ||
| Z-0271-06 | LifeScan OneTouch SureSoft Lancing Device, single use lancing device. | Lifescan, Inc. | NBW | ||
| Z-0303-06 | 3G Storm Series Power Wheelchair with Power Tilt Option. | Invacare GmbH | ITI | ||
| Z-0272-06 | LifeScan OneTouch Ultra Primary Care Physician Demo Kits, Blood Glucose Meter | Lifescan, Inc. | NBW | ||
| Z-0154-06 | Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and... | Medrad, Inc. | DXT | ||
| Z-0089-06 | Medrad Overhead Counterpoise System II. Support Arm. Mount Injector Head. Catalog numbers... | Medrad, Inc. | JAK | ||
| Z-0187-05 | CTX 5500 DS and CTX 2500 Explosive Detection Systems (EDS); Product is manufactured by... | Invision Technologies Inc | ZZZ |