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-1756-2016 | Class II | American Surgical Cotton Balls-Strung 3/4" Ref Number: 30-03 Product Usage: Neurosurgical... | American Surgical Company, LLC | GDY | |
| Z-1632-2016 | Class II | Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C... | Abbott Medical | LWS | |
| Z-1605-2016 | Class II | Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor... | Medtronic, Inc. | NVZ | |
| Z-1755-2016 | Class II | American Surgical Cotton Balls-Strung 1/2" Ref Number: 30-02 Product Usage: Neurosurgical... | American Surgical Company, LLC | GDY | |
| Z-1754-2016 | Class II | American Surgical Cotton Balls-Strung 3/8" Ref Number: 30-01 Product Usage: Neurosurgical... | American Surgical Company, LLC | GDY | |
| Z-1753-2016 | Class II | American Surgical Cotton Balls-Strung 1/4" Ref Number: 30-00 Product Usage: Neurosurgical... | American Surgical Company, LLC | GDY | |
| Z-1752-2016 | Class II | American Surgical Ultracot 70 mm x 10090 mm Ref Number: 23-24 Product... | American Surgical Company, LLC | GDY | |
| Z-1751-2016 | Class II | American Surgical Ultracot 30 mm x 90 mm (Glassine) Ref Number: 23-15G Product... | American Surgical Company, LLC | GDY | |
| Z-1750-2016 | Class II | American Surgical Ultracot 15 mm x 15 mm (Glassine) Ref Number: 23-12G Product... | American Surgical Company, LLC | GDY | |
| Z-1749-2016 | Class II | American Surgical Ultracot 30 mm x 70 mm (Glassine) Ref Number: 23-10G Product... | American Surgical Company, LLC | GDY | |
| Z-1748-2016 | Class II | American Surgical Ultracot 30 mm x 70 mm Ref Number: 23-10 Product Usage: Neurosurgical... | American Surgical Company, LLC | GDY | |
| Z-1747-2016 | Class II | American Surgical Ultracot 20 mm x 60 mm (Glassine) Ref Number: 23-09G Product... | American Surgical Company, LLC | GDY | |
| Z-1746-2016 | Class II | American Surgical Ultracot 20 mm x 60 mm Ref Number: 23-09 Product Usage: Neurosurgical... | American Surgical Company, LLC | GDY | |
| Z-1745-2016 | Class II | American Surgical Ultracot 13 mm x 60 mm (Glassine) Ref Number: 23-08G Product... | American Surgical Company, LLC | GDY | |
| Z-1744-2016 | Class II | American Surgical Ultracot 13 mm x 60 mm Ref Number: 23-08 Product Usage: Neurosurgical... | American Surgical Company, LLC | GDY | |
| Z-1743-2016 | Class II | American Surgical Ultracot 9 mm x 50 mm (Glassine) Ref Number: 23-07G Product... | American Surgical Company, LLC | GDY | |
| Z-1742-2016 | Class II | American Surgical Ultracot 6 mm x 50 mm Ref Number: 23-06 Product Usage: Neurosurgical... | American Surgical Company, LLC | GDY | |
| Z-1741-2016 | Class II | American Surgical Ultracot 15 mm x 20 mm (Glassine) Ref Number: 23-04G Product... | American Surgical Company, LLC | GDY | |
| Z-1740-2016 | Class II | American Surgical Ultracot 15 mm x 20 mm Ref Number: 23-04 Product Usage: Neurosurgical... | American Surgical Company, LLC | GDY | |
| Z-1739-2016 | Class II | American Surgical Ultracot 10 mm x 13 mm (Glassine) Ref Number: 23-03G Product... | American Surgical Company, LLC | GDY | |
| Z-1738-2016 | Class II | American Surgical Ultracot 5 mm x 13 mm (Glassine) Ref Number: 23-02G Product... | American Surgical Company, LLC | GDY | |
| Z-1737-2016 | Class II | American Surgical Ultracot 5 mm x 8 mm (Glassine) Ref Number: 23-01G Product... | American Surgical Company, LLC | GDY | |
| Z-1736-2016 | Class II | American Surgical Ultracot 5 mm x 8 mm Ref Number: 23-01 Product Usage: Neurosurgical... | American Surgical Company, LLC | GDY | |
| Z-1735-2016 | Class II | American Surgical Americot Blue 1/2" x 2" Ref Number: 20-32S Product Usage: Neurosurgical... | American Surgical Company, LLC | GDY | |
| Z-1734-2016 | Class II | American Surgical Americot White 1.5 cm x 5.5 cm Ref Number: 20-31SW Product... | American Surgical Company, LLC | GDY | |
| Z-1733-2016 | Class II | American Surgical Americot Blue 1/4" x 1.5" Ref Number: 20-30S Product... | American Surgical Company, LLC | GDY | |
| Z-1732-2016 | Class II | American Surgical Americot Blue 3/8" x 2" Ref Number: 20-26S Product Usage: Neurosurgical... | American Surgical Company, LLC | GDY | |
| Z-1731-2016 | Class II | American Surgical Americot Blue 3/8" x 3/8" Ref Number: 20-22S Product... | American Surgical Company, LLC | GDY | |
| Z-1730-2016 | Class II | American Surgical Americot Blue 1/8" x 1/8" Ref Number: 20-19S Product... | American Surgical Company, LLC | GDY | |
| Z-1729-2016 | Class II | American Surgical Americot Blue 3/8" x 3/4" Ref Number: 20-14S Product... | American Surgical Company, LLC | GDY | |
| Z-1728-2016 | Class II | American Surgical Americot Blue 1" x 3" Ref Number: 20-10S Product Usage: Neurosurgical... | American Surgical Company, LLC | GDY | |
| Z-1727-2016 | Class II | American Surgical Americot Blue 1/2" x 3" Ref Number: 20-07S Product Usage: Neurosurgical... | American Surgical Company, LLC | GDY | |
| Z-1726-2016 | Class II | American Surgical Americot Blue 1/2" x 1.5" Ref Number: 20-06S Product... | American Surgical Company, LLC | HBA | |
| Z-1725-2016 | Class II | American Surgical Americot Blue 1/2" x 1" Ref Number: 20-05S Product Usage: Neurosurgical... | American Surgical Company, LLC | HBA | |
| Z-1724-2016 | Class II | American Surgical Americot Blue 1/2" x 1/2" Ref Number: 20-04S Product... | American Surgical Company, LLC | GDY | |
| Z-1723-2016 | Class II | American Surgical Americot Blue 1/4" x 1/4" Ref Number: 20-01S Product... | American Surgical Company, LLC | GDY | |
| Z-1523-2016 | Class III | Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number... | Biocare Medical LLC | NJT | |
| Z-1580-2016 | Class II | Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432. | Hologic, Inc. | NUA | |
| Z-1579-2016 | Class II | CF InPlex ASR Card; Catalog Number: 95-0501. | Hologic, Inc. | NUA | |
| Z-1570-2016 | Class II | BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are... | Becton, Dickinson and Company, BD Biosciences | GKZ | |
| Z-1585-2016 | Class II | X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage... | Shimadzu Medical Systems | IXR | |
| Z-1722-2016 | Class II | American Surgical Delicot 30mm x 70mm Ref: 63-10 Product Usage: Neurosurgical and... | American Surgical Company, LLC | HBA | |
| Z-1721-2016 | Class II | American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgical and... | American Surgical Company, LLC | HBA | |
| Z-1992-2016 | Class II | Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0... | Medtec LLC | JAI | |
| Z-1615-2016 | Class III | ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-1581-2016 | Class II | reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The... | LED Technologies, Inc. | ILY | |
| Z-2213-2016 | Class II | AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7... | Amd-Ritmed, Inc. | FQM | |
| Z-1582-2016 | Class II | Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only... | Teleflex Medical | CAC | |
| Z-1552-2016 | Class II | ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO... | ev3, Inc. | LIT | |
| Z-1503-2016 | Class II | Ad-Tech Electrode Connection System/Cables. Lightweight TECH-ATTACH Cable Models: 1... | AD-Tech Medical Instrument Corp. | IKD |
