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