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-1310-2009 | Coated VICRYL Plus Antibacterial (polyglactin 910) Suture; Ethicon Inc., A Johnson &... | Ethicon, Inc | GAM | ||
| Z-1309-2009 | Coated VICRYL (Polyglactin 910) Suture, Ethicon Inc., A Johnson & Johnson Company... | Ethicon, Inc | GAM | ||
| Z-1202-2009 | Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI... | Horiba Instruments Incorporated | CIG | ||
| Z-0604-2010 | DPX-Bravo/Duo, GE Lunar DEXA bone densitometers operating with enCORE software versions... | GE Healthcare | KGI | ||
| Z-0603-2010 | DPX-MD series, GE Lunar DEXA bone densitometers operating with enCORE software versions... | GE Healthcare | KGI | ||
| Z-0602-2010 | DPX-NT series, GE Lunar DEXA bone densitometers operating with enCORE software versions... | GE Healthcare | KGI | ||
| Z-0601-2010 | Prodigy 1-8 series, GE Lunar DEXA bone densitometers operating with enCORE software... | GE Healthcare | KGI | ||
| Z-0600-2010 | iDXA, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0... | GE Healthcare | KGI | ||
| Z-0412-2011 | Philips EasyVision MM workstation with software R10.2 and R11.1 The EasyVision MM... | Philips North America LLC | LLZ | ||
| Z-0937-2009 | MilCAM Recon III Model Family of IR Imagers that incorporate a Class I infared laser for... | Flir Systems | REQ | ||
| Z-1251-2009 | Modular Replacement System (MRS) Cemented Stems, Sterile, Catalog Numbers: 6485-3-000... | Howmedica Osteonics Corp | KRO | ||
| Z-1058-2009 | Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra... | Zimmer GmbH | JDC | ||
| Z-1057-2009 | Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra... | Zimmer GmbH | JDC | ||
| Z-1056-2009 | Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra... | Zimmer GmbH | JDC | ||
| Z-1055-2009 | Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra... | Zimmer GmbH | JDC | ||
| Z-1054-2009 | Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 6 inch... | Zimmer GmbH | JDC | ||
| Z-1053-2009 | Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 4 inch... | Zimmer GmbH | JDC | ||
| Z-1228-2009 | MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe for... | Medrad, Inc. | DXT | ||
| Z-1007-2010 | BD FACSCount Controls Kit, An Automated Differential Cell Counter, Model/Catalog Number... | Becton, Dickinson and Company, BD Biosciences | GKZ | ||
| Z-0748-2010 | Jeanes Hospital Custom Cath Procedure Tray, K09T-08945A, Sterile EO, Merit Medical... | Merit Medical Systems, Inc. | OEZ | ||
| Z-0747-2010 | Jeanes Hospital Custom Cath Procedure Tray, K09T-08945, Sterile EO, Merit Medical... | Merit Medical Systems, Inc. | OEZ | ||
| Z-0746-2010 | Custom Angiographic Kit, K09-MS3084, Sterile EO, Merit Medical Systems, Inc., South... | Merit Medical Systems, Inc. | OEZ | ||
| Z-0745-2010 | Custom Cardiac Cath Pack Kit, K09-08945, Sterile EO, Merit Medical Systems, Inc., South... | Merit Medical Systems, Inc. | OEZ | ||
| Z-0744-2010 | University Health System Custom Cardiac Cath Pack, K09T-02178, Srterile EO, Merit Medical... | Merit Medical Systems, Inc. | OEZ | ||
| Z-1201-2009 | Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc... | Horiba Instruments Incorporated | LBR | ||
| Z-1200-2009 | Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc... | Horiba Instruments Incorporated | LBR | ||
| Z-0996-2009 | Zimmer Most Hinged Tibia Baseplate Spacer, size 1, 6 mm, sterile, Zimmer, Warsaw, IN; REF... | Zimmer GmbH | KRO | ||
| Z-0498-2010 | ILLICO Posterior Thoracolumbar Access Retractor, Part Number: 73520 The ILLICO... | Alphatec Spine, Inc. | GAD | ||
| Z-1542-2009 | TumorLoc software for the Brilliance Big Bore (BB) and the CT Extended Brilliance... | Philips North America LLC | JAK | ||
| Z-1052-2009 | Stryker Impaction Bur Guard REF 2296-301, 2296-300, 0260-901-300, & 5400-300; Stryker... | Stryker Corp. | HWE | ||
| Z-0102-2011 | SoftPath GUI version 4.2.3.4 2008-06-30 (Manuf Date). SoftPath GUI version 4.2.4.1... | SCC Soft Computer | LNX | ||
| Z-0261-2010 | GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI TF, 16, 64, and 16 Base Slice... | Philips North America LLC | JAK | ||
| Z-0260-2010 | GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI GXL, 16 Slice and 6 Slice... | Philips North America LLC | JAK | ||
| Z-0897-2011 | Precedence SPECT/CT System, Precedence 16 3/8, Upper Patient Pallet, A single photon... | Philips North America LLC | INQ | ||
| Z-1226-2009 | Hancock II Bioprostheses with Cinch, Heart Valve, Model # T505 & T510; Catalog #s... | Medtronic, Inc. | DYE | ||
| Z-1225-2009 | Medtronic Mosaic Porcine Bioprostheses with Cinch, Heart Valve; Model 305; Catalog #s... | Medtronic, Inc. | DYE | ||
| Z-0888-2011 | Varian Medical Systems Floorstand. An accessory of the Optical Guidance Platform, Model... | Varian Medical Systems, Inc. | IYE | ||
| Z-1039-2009 | GE Healthcare, S/5 iCentral and iCentral Client, Related to software licenses L-NET05... | GE Healthcare | MSX | ||
| Z-0962-2012 | ***CAT#: 9297A***LINVATEC***Arthroscopic Blade***4.8mm GREAT WHITE, 13cm long***Qty... | Stryker Sustainability Solutions | HRX | ||
| Z-0961-2012 | ***CAT 375-941-012***STRYKER***Arthroscopic Burr***4.0mm BARREL BUR***Hollow 12... | Stryker Sustainability Solutions | HRX | ||
| Z-0960-2012 | ***CAT 375-941-000***STRYKER***Arthroscopic Bur***4.0mm BARREL BUR***Hollow 6... | Stryker Sustainability Solutions | HRX | ||
| Z-0959-2012 | ***CAT 375-532-000***STRYKER***Arthroscopic Blade***3.5mm RESECTOR***Hub Style... | Stryker Sustainability Solutions | HRX | ||
| Z-0958-2012 | ***CAT 275-534-000***STRYKER***Arthroscopic Blade***3.5mm AGGRESSIVE... | Stryker Sustainability Solutions | HRX | ||
| Z-0957-2012 | ***CAT 375-544-000***STRYKER***Arthroscopic Blade***4.0mm AGGRESSIVE PLUS***Hub Style... | Stryker Sustainability Solutions | HRX | ||
| Z-0956-2012 | ***CAT 375-545-000***STRYKER***Arthroscopic Blade***4.0mm TOMCAT CUTTER***Hub Style... | Stryker Sustainability Solutions | HRX | ||
| Z-0955-2012 | ***CAT 275-941-000***STRYKER***Arthroscopic Burr***4.0mm BARREL BUR Hollow 6... | Stryker Sustainability Solutions | HRX | ||
| Z-0954-2012 | ***CAT 275-542-000***STRYKER***Arthroscopic Blade***4.0mm RESECTOR***Red***SAMPLE... | Stryker Sustainability Solutions | HRX | ||
| Z-0953-2012 | ***CAT 7205345***DYONICS***Arthroscopic Blade***4.5mm INCISOR PLUS, 13cm long***Fits... | Stryker Sustainability Solutions | HRX | ||
| Z-0952-2012 | ***CAT 7205330***DYONICS***Arthroscopic Burr, Wide Mouth***4.0mm STONECUTTER, 13cm... | Stryker Sustainability Solutions | HRX | ||
| Z-0951-2012 | ***CAT 7205326***DYONICS***Arthroscopic Burr, Wide Mouth***4.0mm ACROMIONIZER, 13cm... | Stryker Sustainability Solutions | HRX |