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-2604-2017 | Class II | MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512, MMT-1712... | Medtronic, Inc. | OZP | |
| Z-2603-2017 | Class II | MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755. | Medtronic, Inc. | OZO | |
| Z-2602-2017 | Class II | MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750. | Medtronic, Inc. | OZO | |
| Z-2323-2017 | Class II | Infant Warmer System (IWS) | GE Healthcare | FMT | |
| Z-2249-2017 | Class II | Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal... | Alphatec Spine, Inc. | NKB | |
| Z-2210-2017 | Class II | HHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog... | Cell Marque Corp. | MVU | |
| Z-2209-2017 | Class II | CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18 Microbiology... | Cell Marque Corp. | MVU | |
| Z-2208-2017 | Class II | Varicella Zoster Virus 7.0 ml catalog number 364M-18 Microbiology - Analyte Specific... | Cell Marque Corp. | OPL | |
| Z-2207-2017 | Class II | SV40 (MRQ-4) 0.5 ml catalog number 351 M-15. Microbiology - Analyte Specific Reagent In... | Cell Marque Corp. | MVU | |
| Z-2206-2017 | Class II | Herpes Simplex Virus II 0.5 ml catalog number 362A-15 7.0 mL Catalog number362A-18... | Cell Marque Corp. | LKC | |
| Z-2205-2017 | Class II | Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Analyte Specific... | Cell Marque Corp. | LKC | |
| Z-2204-2017 | Class II | Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-26; 7.0 mL... | Cell Marque Corp. | NYQ | |
| Z-2203-2017 | Class II | Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic use... | Cell Marque Corp. | NYQ | |
| Z-2202-2017 | Class II | H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyte Specific... | Cell Marque Corp. | OWF | |
| Z-2201-2017 | Class II | Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Analyte Specific... | Cell Marque Corp. | MVU | |
| Z-2200-2017 | Class II | Estrogen Receptor (EP1) 7.0 mL Catalog number 249R-28; 1.0 mL Catalog number... | Cell Marque Corp. | MVU | |
| Z-2199-2017 | Class II | Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog number... | Cell Marque Corp. | GOD | |
| Z-2153-2017 | Class II | Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged... | Innovasis, Inc | KWQ | |
| Z-2533-2017 | Class II | Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm... | Applied Medical Resources Corp | GCJ | |
| Z-2175-2017 | Class II | NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383) | Philips North America LLC | MHX | |
| Z-2585-2017 | Class II | OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in... | Cook Incorporated | GEX | |
| Z-2540-2017 | Class II | Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber... | Cook Incorporated | FFS | |
| Z-2548-2017 | Class II | SCHRITTMACHER ANGIO X3; Item Number: 4045255423347 | Medtronic, Inc. | GAM | |
| Z-2547-2017 | Class II | CUSTOM SUTURE PACK; Item Number: US1540 and US1614 | Medtronic, Inc. | GAM | |
| Z-2546-2017 | Class II | USPACK-SUTURE KIT; Item Number: US1672 | Medtronic, Inc. | GAM | |
| Z-2545-2017 | Class II | Best Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211, 00Z2212... | Medtronic, Inc. | GAM | |
| Z-2544-2017 | Class II | Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M | Medtronic, Inc. | GAM | |
| Z-2543-2017 | Class II | Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO... | Medtronic, Inc. | GAM | |
| Z-2542-2017 | Class II | Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0... | Medtronic, Inc. | GAM | |
| Z-2541-2017 | Class II | Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO... | Medtronic, Inc. | GAM | |
| Z-2703-2017 | Class II | Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 | GE Healthcare | BSZ | |
| Z-2125-2017 | Class II | Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD | Implant Direct Sybron Manufacturing LLC | DZE | |
| Z-2090-2017 | Class II | Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer... | FUJIFILM Healthcare Americas Corporation | IYN | |
| Z-0639-2018 | Class II | ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for... | Zimmer GmbH | OLO | |
| Z-0638-2018 | Class II | ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for... | Zimmer GmbH | HAW | |
| Z-2712-2017 | Class II | APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound... | Canon Medical Systems USA, Inc. | IYN | |
| Z-2711-2017 | Class II | APLIO 500 TUS-A500 diagnostic ultrasound system | Canon Medical Systems USA, Inc. | IYN | |
| Z-2710-2017 | Class II | APLIO 300 TUS-A300 diagnostic ultrasound system | Canon Medical Systems USA, Inc. | IYN | |
| Z-2709-2017 | Class II | XARIO 200 TUS-X200 diagnostic ultrasound system | Canon Medical Systems USA, Inc. | IYN | |
| Z-2708-2017 | Class II | XARIO 100 TUS-X100 diagnostic ultrasound system | Canon Medical Systems USA, Inc. | IYN | |
| Z-2250-2017 | Class II | SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous... | Circadiance | NPE | |
| Z-2315-2017 | Class II | LapSac Introducer Set, Bag, Extraction, Supplied sterilized by ethylene oxide gas in... | Cook Incorporated | GCJ | |
| Z-2314-2017 | Class II | LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages. Used... | Cook Incorporated | GCJ | |
| Z-2313-2017 | Class II | Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide... | Cook Incorporated | FHQ | |
| Z-2312-2017 | Class II | Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene... | Cook Incorporated | KOA | |
| Z-2311-2017 | Class II | Willscher Vas Skewers, Surgical Instrument, Supplied sterilized by ethylene oxide gas in... | Cook Incorporated | KOA | |
| Z-2310-2017 | Class II | Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene... | Cook Incorporated | KOA | |
| Z-2634-2017 | Class II | TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring... | Datascope Corp. | MHX | |
| Z-2588-2017 | Class II | Monica Novii Wireless Patch System product Usage: Novii Interface - The Novii Interface... | Monica Healthcare | OSP | |
| Z-2219-2017 | Class II | Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample... | Exact Sciences Corporation- Innovation Campus | PHP |