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-0840-2010 | BD Nexiva Closed IV Catheter System, REF 383649, 18GA 1.25IN, Becton Dickinson Infusion... | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | ||
| Z-0839-2010 | BD Nexiva Closed IV Catheter System, REF 383647, 20GA 1.25IN, Becton Dickinson Infusion... | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | ||
| Z-0838-2010 | BD Nexiva Closed IV Catheter System, REF 383540, 18GA 1.75IN, Becton Dickinson Infusion... | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | ||
| Z-0837-2010 | BD Nexiva Closed IV Catheter System, REF 383539, 18GA 1.25IN, Becton Dickinson Infusion... | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | ||
| Z-0836-2010 | BD Nexiva Closed IV Catheter System, REF 383538, 20GA 1.75IN, Becton Dickinson Infusion... | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | ||
| Z-0835-2010 | BD Nexiva HF Closed IV Catheter System, REF 383537, 20GA 1.25IN, Becton Dickinson... | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | ||
| Z-0834-2010 | BD Nexiva Closed IV Catheter System, REF 383536, 20GA 1.00IN, Becton Dickinson Infusion... | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | ||
| Z-0833-2010 | BD Nexiva Closed IV Catheter System, REF 383534, 20GA 1.25IN, Becton Dickinson Infusion... | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | ||
| Z-0832-2010 | BD Nexiva Closed IV Catheter System, REF 383533, 20GA 1.00IN, Becton Dickinson Infusion... | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | ||
| Z-0831-2010 | BD Nexiva Closed IV Catheter System, REF 383532, 22GA 1.00IN, Becton Dickinson Infusion... | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | ||
| Z-0830-2010 | BD Nexiva Closed IV Catheter System, REF 383531, 24GA 0.75IN, Becton Dickinson Infusion... | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | ||
| Z-0829-2010 | BD Nexiva Closed IV Catheter System, REF 383530, 24GA 0.56IN, Becton Dickinson Infusion... | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | ||
| Z-1251-2010 | Artisan brand Extend Control Catheter; An Steerable Guide Catheter; Component of Sensei X... | Hansen Medical, Inc. | DXX | ||
| Z-0756-2010 | MPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385164 | Becton Dickinson Infusion Therapy Systems Inc. | FPA | ||
| Z-0755-2010 | MPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385151 | Becton Dickinson Infusion Therapy Systems Inc. | FPA | ||
| Z-0754-2010 | MPS Acacia Extension Set, 15cm RightBore-18, Spin Nut w/BBD Q-Syte, REF 385150, | Becton Dickinson Infusion Therapy Systems Inc. | FPA | ||
| Z-0753-2010 | BD Q-Syte Vial Access Adapter, 0.16 ml, REF 385108, Becton Dickinson Infusion Therapy... | Becton Dickinson Infusion Therapy Systems Inc. | FPA | ||
| Z-0752-2010 | BD Q-Syte Extension Set, 15 cm, P.V. 0.21 ml, REF 385102, Becton Dickinson Infusion... | Becton Dickinson Infusion Therapy Systems Inc. | FPA | ||
| Z-0751-2010 | BD Q-Syte Extension Set, 15cm Std Bore, P.V. 1.14 ml Luer-Lok, REF 385101, Becton... | Becton Dickinson Infusion Therapy Systems Inc. | FPA | ||
| Z-0750-2010 | BD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100, Becton Dickinson Infusion... | Becton Dickinson Infusion Therapy Systems Inc. | FPA | ||
| Z-0104-2010 | Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI... | Horiba Instruments Incorporated | CFR | ||
| Z-1399-2010 | Quick Connect Adapter Model #CSS-QA-Adapter MaxTorque(R) Maxtorque Quick Connect Lot... | TORNIER Inc. | LXH | ||
| Z-0891-2011 | 4D Integrated Treatment Console, versions: 8.0.12, 8.0.23 SP2, 8.1 SP2, 8.1.1.3, 8.1.1.4... | Varian Medical Systems, Inc. | IYE | ||
| Z-0272-2010 | Richard Wolf Hulka Clip; for single patient use only; a sterile tubal occluding device... | Richard Wolf Medical Instruments Corp. | HGB | ||
| Z-1683-2010 | Responder 2000 Defibrillator/Monitor Models: 2025653, 2026109, and 2026114. Intended... | ZOLL Medical Corporation | MKJ | ||
| Z-0087-2010 | Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. Thomas Medical Products, Inc. 65... | Cordis US Corp. | DYB | ||
| Z-0540-2010 | GE Healthcare, Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging Systems... | GE Healthcare | MQB | ||
| Z-0422-2010 | HeartMate 12 volt sealed lead acid Battery Clips that are components of the HeartMate II... | Abbott Medical | DSQ | ||
| Z-0486-2010 | E-Z CLEAN Non Stick Cautery Tip. Label reads in part: "MEGADYNE 11506 SOUTH STATE STREET... | Megadyne Medical Products, Inc | GEI | ||
| Z-0763-2010 | Stryker Reflex Hybrid Screw Extractor Inner Shaft; Not Sterile; Manufactured by: Stryker... | Howmedica Osteonics Corp | KWQ | ||
| Z-0762-2010 | Stryker Reflex Hybrid Screw Extractor; Not Sterile: Manufactured by: Stryker Spine... | Howmedica Osteonics Corp | KWQ | ||
| Z-1914-2010 | GammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100 test kit ), CA-1553 (... | Diasorin Inc. | CIB | ||
| Z-1026-2010 | BD Vacutainer Urine Complete Kit with UA tube and C&C Preservative Tube for Midstream... | Becton Dickinson & Co | JTW | ||
| Z-1025-2010 | BD Vacutainer Urine Complete Kit with UA Preservative Tube and C&S Preservative Tube for... | Becton Dickinson & Co | JSM | ||
| Z-1024-2010 | BD Vacutainer Urine Complete Kit with UA Tube and S&C Preservative Tube for Midstream... | Becton Dickinson & Co | JSM | ||
| Z-1023-2010 | BD Vacutainer Urine Cup Kit with C&S Preservative Tube for Midstream specimens; 50... | Becton Dickinson & Co | JSM | ||
| Z-0867-2010 | Variant II Turbo Hemoglobin A1c Program, model number 270 2417, manufactured by Bio-Rad... | Bio-Rad Laboratories Inc. | LCP | ||
| Z-1424-2010 | Cardiac Science, Automated External Defibrillator (AED) under the following brand names... | ZOLL Medical Corporation | MKJ | ||
| Z-0262-2010 | Intramedullary Skeletal Kinetic Distractor (ISKD) is an internal limb lengthening device... | Orthofix SRL | HSB | ||
| Z-0910-2011 | C-Series Clinac, Trilogy and Novalis Tx used for SRS treatments, Model Numbers H14, H18... | Varian Medical Systems, Inc. | IYE | ||
| Z-0276-2010 | Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1620. Bard... | Bard Peripheral Vascular Inc | FCG | ||
| Z-0275-2010 | Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1616. Bard... | Bard Peripheral Vascular Inc | FCG | ||
| Z-0274-2010 | Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1613. Bard... | Bard Peripheral Vascular Inc | FCG | ||
| Z-0273-2010 | Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1610. Bard... | Bard Peripheral Vascular Inc | FCG | ||
| Z-0258-2010 | Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface... | Zimmer GmbH | JWH | ||
| Z-0257-2010 | Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface... | Zimmer GmbH | JWH | ||
| Z-0256-2010 | Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface... | Zimmer GmbH | JWH | ||
| Z-0255-2010 | Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface... | Zimmer GmbH | JWH | ||
| Z-0254-2010 | Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface... | Zimmer GmbH | JWH | ||
| Z-0253-2010 | Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface... | Zimmer GmbH | JWH |