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-1820-2018 | Class II | Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm - 3.5mm ( Item Code... | Medtronic, Inc. | GDW | |
| Z-1819-2018 | Class II | Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm -2.5mm ( Item Code... | Medtronic, Inc. | GDW | |
| Z-1818-2018 | Class II | Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm- 3.5mm( Item Code... | Medtronic, Inc. | GDW | |
| Z-1817-2018 | Class II | Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm - 2.5mm( Item Code... | Medtronic, Inc. | GDW | |
| Z-1816-2018 | Class II | Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 3.5mm ( Item Code... | Medtronic, Inc. | GDW | |
| Z-1815-2018 | Class II | Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 2.5mm ( Item Code... | Medtronic, Inc. | GDW | |
| Z-1814-2018 | Class II | Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm ( Item Code... | Medtronic, Inc. | GDW | |
| Z-2302-2018 | Class II | Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000 | Intersurgical Ltd. | CAI | |
| Z-1911-2018 | Class II | Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400 Compounding... | Baxter Healthcare Corporation | LHI | |
| Z-1910-2018 | Class II | Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400... | Baxter Healthcare Corporation | LHI | |
| Z-1909-2018 | Class II | Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400... | Baxter Healthcare Corporation | LHI | |
| Z-1908-2018 | Class II | Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product... | Baxter Healthcare Corporation | LHI | |
| Z-1627-2018 | Class II | Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net... | Conseal International, Inc. | FRO | |
| Z-1890-2018 | Class II | Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product... | ConvaTec Limited | MMH | |
| Z-2360-2018 | Class II | Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an... | Biocare Medical LLC | NJT | |
| Z-2377-2018 | Class II | Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754 | Medtronic, Inc. | FPA | |
| Z-1936-2018 | Class II | MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas... | MEDLINE INDUSTRIES, LP - Northfield | GAB | |
| Z-1935-2018 | Class II | MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / Foam Block... | MEDLINE INDUSTRIES, LP - Northfield | GAB | |
| Z-1934-2018 | Class II | MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block... | MEDLINE INDUSTRIES, LP - Northfield | GAB | |
| Z-1933-2018 | Class II | MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Magnet, reorder: DYNJNC40F Product... | MEDLINE INDUSTRIES, LP - Northfield | GAB | |
| Z-1932-2018 | Class II | MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC40A Product... | MEDLINE INDUSTRIES, LP - Northfield | GAB | |
| Z-1931-2018 | Class II | MEDLINE Sterile* Needle Counter, 100Ct. Double Magnet / Foam Block, reorder... | MEDLINE INDUSTRIES, LP - Northfield | GAB | |
| Z-1926-2018 | Class II | Prismaflex 7.20 US, Product Code 955542 Intended Use: The Prismaflex Control Unit is... | Baxter Healthcare Corporation | KDI | |
| Z-1925-2018 | Class II | Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Control Unit is... | Baxter Healthcare Corporation | KDI | |
| Z-1924-2018 | Class II | Prismaflex 7.XX ROW, Product Code 114870 Intended Use: The Prismaflex Control Unit is... | Baxter Healthcare Corporation | KDI | |
| Z-1923-2018 | Class II | Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Control Unit is... | Baxter Healthcare Corporation | KDI | |
| Z-1922-2018 | Class II | Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Control Unit is... | Baxter Healthcare Corporation | KDI | |
| Z-2381-2018 | Class II | da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box. | Intuitive Surgical, Inc. | GDW | |
| Z-2380-2018 | Class II | da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box. | Intuitive Surgical, Inc. | GDW | |
| Z-1583-2018 | Class II | DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord... | DeRoyal Industries, Inc. | GEI | |
| Z-2471-2018 | Class II | t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware... | Tandem Diabetes Care, Inc. | OYC | |
| Z-1139-2019 | Class II | A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad... | Pintler Medical | DWJ | |
| Z-0385-2019 | Class II | Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump... | CareFusion 303, Inc | FPA | |
| Z-1901-2018 | Class II | Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #... | LivaNova USA, Inc. | DWC | |
| Z-1940-2018 | Class II | SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1939-2018 | Class II | SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-2041-2018 | Class II | LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code LXM-xx... | Torax Medical, Inc. | LEI | |
| Z-2040-2018 | Class II | LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LX-xx... | Torax Medical, Inc. | LEI | |
| Z-2039-2018 | Class II | LINX Reflux Management System, Implant Clasp, 13-17 Bead, 1.5T, Product Code LXMC-xx... | Torax Medical, Inc. | LEI | |
| Z-2038-2018 | Class II | LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx... | Torax Medical, Inc. | LEI | |
| Z-2037-2018 | Class II | LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code LS-xx... | Torax Medical, Inc. | LEI | |
| Z-2107-2018 | Class II | MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease... | MicroAire Surgical Instruments, LLC | HRX | |
| Z-2182-2018 | Class II | Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme... | Siemens Healthcare Diagnostics Inc. | LCD | |
| Z-2181-2018 | Class II | Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot... | Siemens Healthcare Diagnostics Inc. | LCD | |
| Z-1937-2018 | Class II | VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017... | Maquet SAS | FTD | |
| Z-2964-2018 | Class II | DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD) | Canon Medical Systems USA, Inc. | MQB | |
| Z-2291-2018 | Class II | Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004 | Exsurco Medical, Inc. | GFD | |
| Z-2538-2018 | Class II | BLAST Bandage, sterile. | Tacmed Solutions, LLC | FQM | |
| Z-1952-2018 | Class II | Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A... | Gyrus ACMI, Inc. | FAS | |
| Z-2877-2018 | Class II | Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is... | Trimed Inc | HRS |