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 590 of 1191
FDA device recalls, page 590 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1756-2016Class IIAmerican Surgical Cotton Balls-Strung 3/4" Ref Number: 30-03 Product Usage: Neurosurgical...American Surgical Company, LLCGDY
Z-1632-2016Class IIEllipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C...Abbott MedicalLWS
Z-1605-2016Class IIMedtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor...Medtronic, Inc.NVZ
Z-1755-2016Class IIAmerican Surgical Cotton Balls-Strung 1/2" Ref Number: 30-02 Product Usage: Neurosurgical...American Surgical Company, LLCGDY
Z-1754-2016Class IIAmerican Surgical Cotton Balls-Strung 3/8" Ref Number: 30-01 Product Usage: Neurosurgical...American Surgical Company, LLCGDY
Z-1753-2016Class IIAmerican Surgical Cotton Balls-Strung 1/4" Ref Number: 30-00 Product Usage: Neurosurgical...American Surgical Company, LLCGDY
Z-1752-2016Class IIAmerican Surgical Ultracot 70 mm x 10090 mm Ref Number: 23-24 Product...American Surgical Company, LLCGDY
Z-1751-2016Class IIAmerican Surgical Ultracot 30 mm x 90 mm (Glassine) Ref Number: 23-15G Product...American Surgical Company, LLCGDY
Z-1750-2016Class IIAmerican Surgical Ultracot 15 mm x 15 mm (Glassine) Ref Number: 23-12G Product...American Surgical Company, LLCGDY
Z-1749-2016Class IIAmerican Surgical Ultracot 30 mm x 70 mm (Glassine) Ref Number: 23-10G Product...American Surgical Company, LLCGDY
Z-1748-2016Class IIAmerican Surgical Ultracot 30 mm x 70 mm Ref Number: 23-10 Product Usage: Neurosurgical...American Surgical Company, LLCGDY
Z-1747-2016Class IIAmerican Surgical Ultracot 20 mm x 60 mm (Glassine) Ref Number: 23-09G Product...American Surgical Company, LLCGDY
Z-1746-2016Class IIAmerican Surgical Ultracot 20 mm x 60 mm Ref Number: 23-09 Product Usage: Neurosurgical...American Surgical Company, LLCGDY
Z-1745-2016Class IIAmerican Surgical Ultracot 13 mm x 60 mm (Glassine) Ref Number: 23-08G Product...American Surgical Company, LLCGDY
Z-1744-2016Class IIAmerican Surgical Ultracot 13 mm x 60 mm Ref Number: 23-08 Product Usage: Neurosurgical...American Surgical Company, LLCGDY
Z-1743-2016Class IIAmerican Surgical Ultracot 9 mm x 50 mm (Glassine) Ref Number: 23-07G Product...American Surgical Company, LLCGDY
Z-1742-2016Class IIAmerican Surgical Ultracot 6 mm x 50 mm Ref Number: 23-06 Product Usage: Neurosurgical...American Surgical Company, LLCGDY
Z-1741-2016Class IIAmerican Surgical Ultracot 15 mm x 20 mm (Glassine) Ref Number: 23-04G Product...American Surgical Company, LLCGDY
Z-1740-2016Class IIAmerican Surgical Ultracot 15 mm x 20 mm Ref Number: 23-04 Product Usage: Neurosurgical...American Surgical Company, LLCGDY
Z-1739-2016Class IIAmerican Surgical Ultracot 10 mm x 13 mm (Glassine) Ref Number: 23-03G Product...American Surgical Company, LLCGDY
Z-1738-2016Class IIAmerican Surgical Ultracot 5 mm x 13 mm (Glassine) Ref Number: 23-02G Product...American Surgical Company, LLCGDY
Z-1737-2016Class IIAmerican Surgical Ultracot 5 mm x 8 mm (Glassine) Ref Number: 23-01G Product...American Surgical Company, LLCGDY
Z-1736-2016Class IIAmerican Surgical Ultracot 5 mm x 8 mm Ref Number: 23-01 Product Usage: Neurosurgical...American Surgical Company, LLCGDY
Z-1735-2016Class IIAmerican Surgical Americot Blue 1/2" x 2" Ref Number: 20-32S Product Usage: Neurosurgical...American Surgical Company, LLCGDY
Z-1734-2016Class IIAmerican Surgical Americot White 1.5 cm x 5.5 cm Ref Number: 20-31SW Product...American Surgical Company, LLCGDY
Z-1733-2016Class IIAmerican Surgical Americot Blue 1/4" x 1.5" Ref Number: 20-30S Product...American Surgical Company, LLCGDY
Z-1732-2016Class IIAmerican Surgical Americot Blue 3/8" x 2" Ref Number: 20-26S Product Usage: Neurosurgical...American Surgical Company, LLCGDY
Z-1731-2016Class IIAmerican Surgical Americot Blue 3/8" x 3/8" Ref Number: 20-22S Product...American Surgical Company, LLCGDY
Z-1730-2016Class IIAmerican Surgical Americot Blue 1/8" x 1/8" Ref Number: 20-19S Product...American Surgical Company, LLCGDY
Z-1729-2016Class IIAmerican Surgical Americot Blue 3/8" x 3/4" Ref Number: 20-14S Product...American Surgical Company, LLCGDY
Z-1728-2016Class IIAmerican Surgical Americot Blue 1" x 3" Ref Number: 20-10S Product Usage: Neurosurgical...American Surgical Company, LLCGDY
Z-1727-2016Class IIAmerican Surgical Americot Blue 1/2" x 3" Ref Number: 20-07S Product Usage: Neurosurgical...American Surgical Company, LLCGDY
Z-1726-2016Class IIAmerican Surgical Americot Blue 1/2" x 1.5" Ref Number: 20-06S Product...American Surgical Company, LLCHBA
Z-1725-2016Class IIAmerican Surgical Americot Blue 1/2" x 1" Ref Number: 20-05S Product Usage: Neurosurgical...American Surgical Company, LLCHBA
Z-1724-2016Class IIAmerican Surgical Americot Blue 1/2" x 1/2" Ref Number: 20-04S Product...American Surgical Company, LLCGDY
Z-1723-2016Class IIAmerican Surgical Americot Blue 1/4" x 1/4" Ref Number: 20-01S Product...American Surgical Company, LLCGDY
Z-1523-2016Class IIIMach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number...Biocare Medical LLCNJT
Z-1580-2016Class IIHologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.Hologic, Inc.NUA
Z-1579-2016Class IICF InPlex ASR Card; Catalog Number: 95-0501.Hologic, Inc.NUA
Z-1570-2016Class IIBD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are...Becton, Dickinson and Company, BD BiosciencesGKZ
Z-1585-2016Class IIX-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage...Shimadzu Medical SystemsIXR
Z-1722-2016Class IIAmerican Surgical Delicot 30mm x 70mm Ref: 63-10 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1721-2016Class IIAmerican Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1992-2016Class IIProtura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0...Medtec LLCJAI
Z-1615-2016Class IIIADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD...Siemens Healthcare Diagnostics Inc.JJE
Z-1581-2016Class IIreVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The...LED Technologies, Inc.ILY
Z-2213-2016Class IIAMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7...Amd-Ritmed, Inc.FQM
Z-1582-2016Class IIPleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only...Teleflex MedicalCAC
Z-1552-2016Class IIev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO...ev3, Inc.LIT
Z-1503-2016Class IIAd-Tech Electrode Connection System/Cables. Lightweight TECH-ATTACH Cable Models: 1...AD-Tech Medical Instrument Corp.IKD