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-0477-2015 | Class II | 7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two... | ZOLL Circulation, Inc. | PAV | |
| Z-1722-2014 | Class II | Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT... | Philips North America LLC | JAK | |
| Z-1610-2014 | Class II | PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee... | Ortho Development Corp. | JWH | |
| Z-1645-2014 | Class II | 550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1652-2014 | Class II | Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1454-2014 | Class I | Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for... | Medtronic, Inc. | DQY | |
| Z-1453-2014 | Class I | Pipeline Embolization Device (PED). Used endovascular treatment of adults with... | Medtronic, Inc. | DQY | |
| Z-1496-2014 | Class II | TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm... | Zimmer GmbH | LPH | |
| Z-1747-2014 | Class II | Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using... | Neo Metrics, Inc. | OCY | |
| Z-2672-2014 | Class II | EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455 | Teleflex Medical | FMI | |
| Z-1462-2014 | Class II | The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is... | GE Healthcare | OWB | |
| Z-1439-2014 | Class II | Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external... | Philips North America LLC | MKJ | |
| Z-1996-2014 | Class II | Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter... | RGI Medical Manufacturing, Inc. | FPA | |
| Z-1697-2014 | Class II | Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S)... | Integra LifeSciences Corporation | HWC | |
| Z-1465-2014 | Class II | Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog... | Terumo Cardiovascular Systems Corporation | OEZ | |
| Z-1437-2014 | Class II | GLOBAL Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019... | Depuy Orthopaedics Inc. | HWT | |
| Z-0020-2015 | Class II | Proteus 235 Proton Therapy System for cancer treatment. | Ion Beam Applications S.A. | IYE | |
| Z-1528-2014 | Class II | INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The... | Mallinckrodt Manufacturing LLC | MRN | |
| Z-1488-2014 | Class II | GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use... | GE Healthcare | IYN | |
| Z-1451-2014 | Class II | Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with... | Central Purchasing LLC dba Harbor Freight Tools | ITJ | |
| Z-1461-2014 | Class II | Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big... | Philips North America LLC | JAK | |
| Z-1516-2014 | Class II | The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is... | Acumed LLC | HRS | |
| Z-1515-2014 | Class II | The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates... | Acumed LLC | HTY | |
| Z-1520-2014 | Class II | VITROS Chemistry Products FS Diluent Pack 3, REF 680 1754, 3 x 45 mL, (D1)/15 mL (D2)... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1519-2014 | Class II | VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1508-2014 | Class II | ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a... | Branan Medical Corp. | DIO | |
| Z-1493-2014 | Class II | Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical... | Stryker Corp. | FYD | |
| Z-2112-2014 | Class I | IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound... | Wellspring Pharmaceutical Corporation | FRO | |
| Z-1627-2014 | Class II | LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection... | Abbott Medical | GBX | |
| Z-1626-2014 | Class II | LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible... | Abbott Medical | GBX | |
| Z-1625-2014 | Class II | LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or... | Abbott Medical | LJH | |
| Z-1624-2014 | Class II | LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch... | Abbott Medical | GBX | |
| Z-1623-2014 | Class II | LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with... | Abbott Medical | LJH | |
| Z-1562-2014 | Class II | AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic... | Allosource | MQV | |
| Z-1321-2014 | Class II | Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot... | Ormco/Sybronendo | EJF | |
| Z-1330-2014 | Class II | Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number... | Ormco/Sybronendo | DYW | |
| Z-1564-2014 | Class II | Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974... | Siemens Healthcare Diagnostics Inc. | CGN | |
| Z-1452-2014 | Class II | Reusable latex breathing bags with multiple part numbers and sold as part of test lung... | Draeger, Inc. | BZO | |
| Z-0215-2015 | Class II | AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case... | Innovatus Imaging Corporation | IYO | |
| Z-1494-2014 | Class II | Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1993-2014 | Class II | Amerigel Wound Dressing 55 gallons/drum | Kova Laboratories, Inc. | MGQ | |
| Z-1992-2014 | Class II | Amerigel Wound Dressing 1 oz. tube | Kova Laboratories, Inc. | MGQ | |
| Z-1866-2014 | Class II | LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses... | LAP of America Laser Applications, LLC. | N/A | |
| Z-1721-2014 | Class II | Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1523-2014 | Class I | Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The... | Datascope Corp. | DSP | |
| Z-1940-2014 | Class II | Stirling Ultracold Portable Shuttle, ULT-25. Storage for cold-chain management... | Global Cooling Inc | JRM | |
| Z-1677-2014 | Class II | enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1540-2014 | Class II | Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model... | Alere San Diego, Inc. | NBC | |
| Z-1502-2014 | Class II | On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow... | Varian Medical Systems, Inc. | IYE | |
| Z-1649-2014 | Class II | Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20... | MEDLINE INDUSTRIES, LP - Northfield | FQM |