510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR

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

59,544 records, page 674 of 1191
FDA device recalls, page 674 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0620-2015Class IIPKG, MARYLAND FORCEPS, CURVED, LEFT, P/N 0250080042. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0619-2015Class IIPKG, LUERLOCK, FEMALE, 6MM TUBING, P/N 0250080208. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0618-2015Class IIPKG, LUERLOCK, MALE, 6MM TUBING, P/N 0250080207. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0617-2015Class IIPKG, BULLET FORCEPS, TAPERED, SERRATED, SPOON, P/N 0250080041. Laparoscopic Manual...Stryker Corp.KOG
Z-0616-2015Class IIPKG, 12.5/11MM - 5.5 REDUCER, P/N 0250080204. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0615-2015Class IIPKG, MICRO SCISSORS, STRAIGHT, P/N 0250080029. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0614-2015Class IIPKG, BABY METZENBAUM SCISSORS, CURVED, P/N 0250080028. Laparoscopic Manual Instruments...Stryker Corp.KOG
Z-0613-2015Class IIPKG, METZENBAUM SCISSORS, CURVED, LONG, P/N 0250080025. Laparoscopic Manual Instruments...Stryker Corp.KOG
Z-0612-2015Class IIPKG, METZENBAUM SCISSORS, STRAIGHT, P/N 0250080024. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0611-2015Class IIPKG, FIXABLE CONE FOR 11MM HASSON, P/N 0250080180. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0610-2015Class IIPKG, HASSON CANNULA, 11MM AUTOMATIC VALVE, STOP COCK, P/N 0250080179. Laparoscopic...Stryker Corp.KOG
Z-0609-2015Class IIPKG, HOOK SCISSORS, P/N 0250080020. Laparoscopic Manual Instruments are intended for...Stryker Corp.KOG
Z-0608-2015Class IIPKG, MIXTER FORCEPS, P/N 0250080010. Laparoscopic Manual Instruments are intended for...Stryker Corp.KOG
Z-0607-2015Class IIPKG, HASSON CANNULA, 5.5MM, AUTOMATIC VALVE, STOP COCK, P/N 0250080176. Laparoscopic...Stryker Corp.KOG
Z-0606-2015Class IIPKG, MARYLAND FORCEPS, CURVED, P/N 0250080009. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0605-2015Class IIPKG, CANNULA 5.5MM AUTOMATIC VALVE STOP COCK W/O TROCAR, P/N 0250080171. Laparoscopic...Stryker Corp.KOG
Z-0604-2015Class IIPKG, OBTURATOR, 5.5MM FOR HASSON CANNULA, P/N 0250080157; Laparoscopic Manual Instruments...Stryker Corp.KOG
Z-0603-2015Class IIPKG, TROCAR 5.5MM PYRAMIDAL TIP, P/N 0250080154; Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0602-2015Class IIPKG, PORTIO ACORN SMALL ONLY, P/N 0250080139; Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0601-2015Class IIPKG, PALPATION PROBE GRADUATED 5MM, P/N 0250080135; Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0600-2015Class IIPKG, MYOMA DRILL 5MM LENGTH 320MM, P/N 0250080133 Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0599-2015Class IIPKG, KNOT PUSHER 5MM OPEN, P/N 0250080132 Laparoscopic Manual Instruments are intended...Stryker Corp.KOG
Z-0598-2015Class IIPKG, FIXATION CLAMP 5MM WITH RATCHET, P/N 0250080130 Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0597-2015Class IIPKG, OP-BIOPSY FORCEPS, SPOON JAW, P/N 0250080007 Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0596-2015Class IIPKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080123 Laparoscopic Manual Instruments...Stryker Corp.KOG
Z-0595-2015Class IIPKG, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080122 Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0594-2015Class IIPKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080121 Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0593-2015Class IIPKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080120 Laparoscopic Manual Instruments...Stryker Corp.KOG
Z-0592-2015Class IIPKG, BIPOLAR FORCEPS, MICRO TIP, 45CM, P/N 0250080115 nationwide in US and worldwide...Stryker Corp.KOG
Z-1017-2016Class IISynthes Small Electric Drive (SED)The Anspach Effort, Inc.HTC
Z-0996-2015Class IIPowered stretcher chair used during facial and eye surgeries. One chair per package.Champion Mfg, Inc.GBB
Z-1006-2015Class IIFLUTTER Percussor respiratory device, packaged one unit per clear plastic package...Aptalis Pharmatech Inc.BYI
Z-0811-2015Class IIBiograph mCT S(40)-4R, System Material Number 10248671. The Siemens Biograph mCT systems...Siemens Medical Solutions USA, Inc.KPS
Z-0810-2015Class IIBiograph mCT S(64)-4R, System Material Number 10248672. The Siemens Biograph mCT systems...Siemens Medical Solutions USA, Inc.KPS
Z-0809-2015Class IIBiograph mCT X-4R, System Material Number 10248670. The Siemens Biograph mCT systems are...Siemens Medical Solutions USA, Inc.KPS
Z-0808-2015Class IIBiograph mCT Flow 40-4R, System Material Number 10529159. The Siemens Biograph mCT...Siemens Medical Solutions USA, Inc.KPS
Z-0807-2015Class IIBiograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT...Siemens Medical Solutions USA, Inc.KPS
Z-0902-2015Class IIABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634...Horiba Instruments IncorporatedJJE
Z-0578-2015Class IIOxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth...Remel IncJSK
Z-0849-2015Class IIIllumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0...Illumina, Inc.PFS
Z-0955-2015Class IIThe Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry...GE HealthcareJAK
Z-0908-2015Class III.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole...Depuy Orthopaedics Inc.LXH
Z-1011-2015Class IIBrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model...Philips North America LLCKPS
Z-0799-2015Class IISheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle...Teleflex MedicalBTR
Z-0934-2015Class IIAlignRT is a video-based three-dimensional (3D) surface imaging system which is used to...Vision Rt IncIYE
Z-0874-2015Class IISolitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594...Ebi, LLCOVE
Z-0587-2015Class IADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use with...Graphic Controls Acquisition Corp.dba Nissha Medical TechnologiesMKJ
Z-0586-2015Class IADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with Philips...Graphic Controls Acquisition Corp.dba Nissha Medical TechnologiesMKJ
Z-0585-2015Class IADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with...Graphic Controls Acquisition Corp.dba Nissha Medical TechnologiesMKJ
Z-0584-2015Class IADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For use with...Graphic Controls Acquisition Corp.dba Nissha Medical TechnologiesMKJ