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-0736-03 | Boston Scientific/Microvasive Open End Ureteral Catheter (7 Fr x 70 cm) Product Number... | Boston Scientific Corporation | GBM | ||
| Z-0740-03 | Boston Scientific/Microvasive Open End Ureteral Catheter (6 Fr x 70 cm) Product Number... | Boston Scientific Corporation | GBM | ||
| Z-0735-03 | Boston Scientific/Microvasive Open End Ureteral Catheter (5 Fr x 70 cm) Product Number... | Boston Scientific Corporation | GBM | ||
| Z-0734-03 | Boston Scientific/Microvasive Open End Ureteral Catheter (4 Fr x 70 cm) Product Number... | Boston Scientific Corporation | GBM | ||
| Z-0703-03 | Glitter Eyes (tefilcon), daily wear soft (hydrophilic) contact lenses packed as single... | Alcon Laboratories | LPL | ||
| Z-0798-03 | Deltec Cozmo Insulin Pump, Model 1700, Product Catalog Numbers 21-1711-01, 21-1712-01 and... | Abbott Medical | LZG | ||
| Z-0814-03 | CoaguChek Plus meter; catalog # 475729 and 12816001. | Roche Diagnostics GmbH | JPA | ||
| Z-0813-03 | CoaguChek Pro DM meter; catalog # 1894048 and 1893211. | Roche Diagnostics GmbH | JPA | ||
| Z-0905-03 | Rational Imaging TM Software, model Ultra 10 PACS System Version 7.1.Xx | Canon Medical Components U.S.A., Inc. | LMB | ||
| Z-0797-03 | Vacuette, Safety Blood Collection Set with Luer Adapter | Greiner Bio-One North America, Inc. | JKA | ||
| Z-0682-03 | Tarsys 1st Generation Seating System - an optional accessory for the Powered Wheelchairs. | Invacare GmbH | ITI | ||
| Z-0846-03 | GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. Part No... | Instrumentation Laboratory Co. | CHL | ||
| Z-0845-03 | GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reagent Cartridge. Part No... | Instrumentation Laboratory Co. | CHL | ||
| Z-0834-03 | Permobil Chairman 2K powered wheelchair | Permobil, AB | ITI | ||
| Z-0547-03 | C1406, QLC1406, C1473, and QLC1473 Quick Connect for Olympus 30/40/160/200/240 Series... | STERIS Corporation | MLR | ||
| Z-0917-03 | COBAS TaqMan analyzer, Series 96; catalog number 8080216. | Roche Molecular Systems Inc | JJF | ||
| Z-1126-03 | Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name... | OLYMPUS Corporation of the Americas | LMB | ||
| Z-0899-03 | STA-Compact Hemostasis System with Cap piercing capability. | Diagnostica Stago, Inc. | GKP | ||
| Z-0709-03 | Paragon Administration Set (100 ml x 0.5 ml/hr) Part Number 5000936 | Halyard Health | FRN | ||
| Z-0704-03 | Midmark M7 UltraClave and Ritter M7 SpeedClave, Tabletop Steam Sterilizers. | Midmark Corp | FLE | ||
| Z-0687-03 | Homepump Eclipse Infusion Pump, Disposable Elastomeric Infusion System (100 ml x 50... | Halyard Health | MEB | ||
| Z-0681-03 | IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent pack contains one 4-mL bottle of... | Abbott Medical | MOI | ||
| Z-0680-03 | CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3... | Abbott Medical | MOI | ||
| Z-0674-03 | ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0679-03 | Abbott AxSYM CA 15-3 Master Calibrator Pack, list 3B42-30; the pack contains two 4-mL... | Abbott Medical | MOI | ||
| Z-0726-03 | Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with AFP... | Abbott Medical | LOJ | ||
| Z-1089-03 | Leonardo Workstations with software versions prior to 2022A | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-1088-03 | Leonardo Workstations with software version 2022A/B, 2003A | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-1087-03 | MR Systems | Siemens Medical Solutions USA, Inc. | LNH | ||
| Z-0979-03 | Axiom Sensis. Programmable Diagnostic Computer | Siemens Medical Solutions USA, Inc. | DQK | ||
| Z-1029-03 | Magic View 1000U, version VE40A. Digital Image Communication System | Siemens Medical Solutions USA, Inc. | |||
| Z-0686-03 | Misys Laboratory version 5.3 | CliniSys, Inc | JQP | ||
| Z-0699-03 | Mitek Profile 8 x 20 mm Cannulated Interference Screw Round Head Product Reference No... | Mitek Worldwide | HWC | ||
| Z-0698-03 | Mitek Profile 7 x 25 mm Cannulated Interference Screw Round Head Product Reference No... | Mitek Worldwide | HWC | ||
| Z-0697-03 | Mitek M. Kurosaka Advantage 9 X 30 mm Cannulated Fixation Screw Product Reference No... | Mitek Worldwide | HWC | ||
| Z-0696-03 | Mitek M. Kurosaka Advantage 7 X 30 mm Cannulated Fixation Screw Product Reference No... | Mitek Worldwide | HWC | ||
| Z-0869-03 | Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with... | Tecan U.S. | JQW | ||
| Z-0789-03 | Medtronic AVE brand BridgeAssurant Balloon Expandable Stent Delivery System for Biliary... | Medtronic, Inc. | FGE | ||
| Z-0781-03 | Halo Support Bracket Assembly (Part #438-B1010). The bracket is sold as a component of... | Ohio Medical Instrument Co., Inc. | GZT | ||
| Z-0712-03 | Gluteraldehyde Concentration Indicators. MetriTest 1.5% and MetriTest 1.8%... | Sybron Dental Specialties, Inc. | JOJ | ||
| Z-0708-03 | DeRoyal''s SurgiMate (tm) Skin Stapler, Rotating Head, product #25-1001, packaged with 35... | Deroyal Surgical -Rose Hill | MNV | ||
| Z-0812-03 | Twister(tm) Cube Back-Cane Short, a wheelchair back seat support strap, part number WPHS. | Action Products, Inc. | IOR | ||
| Z-0664-03 | Sarns MP4 Cardioplegia Sets; catalog number 15501. | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-0005-04 | Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin... | Liberty Medical Supplies | FMF | ||
| Z-0004-04 | Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin... | Liberty Medical Supplies | FMF | ||
| Z-0003-04 | Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes | Liberty Medical Supplies | FMF | ||
| Z-0719-03 | CryoValve Allograft, Heart valve. | Artivion, Inc. | MIE | ||
| Z-0725-03 | AEROSET Software versions 1.00ER005, catalog number 2-89996-01 and 1.00ER005.2, catalog... | Abbott Medical | JJE | ||
| Z-0788-03 | AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number... | Abbott Medical | JJE | ||
| Z-0663-03 | Stretta brand Catheter and Accessory Kit, Part # 175-2575. Model 4301K | Curon Medical, Inc. | DQO |