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-1483-2017 | Class II | .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6... | Acumed LLC | LXH | |
| Z-1858-2017 | Class II | various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing... | Zimmer GmbH | JDS | |
| Z-1826-2017 | Class II | Cordis S.M.A.R.T. Flex Vascular Stent System | Cordis US Corp. | MAF | |
| Z-1487-2017 | Class II | MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx... | Crossroads Extremity Systems LLC | JDR | |
| Z-1497-2017 | Class I | 7F Prelude Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170... | Merit Medical Systems, Inc. | DYB | |
| Z-1769-2017 | Class II | Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number... | Datascope Corp. | DWE | |
| Z-1615-2018 | Class II | Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope... | IntroMedic Co., Ltd. | NEZ | |
| Z-1686-2017 | Class II | Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and... | DiaSorin Molecular LLC | LHL | |
| Z-1685-2017 | Class II | Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human... | DiaSorin Molecular LLC | LHL | |
| Z-2782-2017 | Class II | Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and... | Greatbatch Medical | DYB | |
| Z-1280-2018 | Class II | Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate... | Baxter Healthcare Corporation | KDI | |
| Z-0306-2018 | Class II | Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear... | Svar Life Science AB | LKJ | |
| Z-1491-2017 | Class II | ONCOR" Expression ONCOR" Impression ONCOR" Impression plus | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1490-2017 | Class II | ONCOR" Avant-garde | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1489-2017 | Class II | Mevatron M2/Primus Mid-Energy PRIMUS HI | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1488-2017 | Class II | ARTISTE" MV System | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1495-2017 | Class II | Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For... | Zimmer GmbH | LLZ | |
| Z-2604-2018 | Class II | Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07 | New Era Orthopaedics, LLC | MNI | |
| Z-1704-2017 | Class II | Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-1438-2017 | Class II | CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a... | Abbott Medical | GKZ | |
| Z-1692-2017 | Class II | UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical... | United Orthopedic Corp. | LXH | |
| Z-1929-2017 | Class II | Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg... | OLYMPUS Corporation of the Americas | HET | |
| Z-1202-2017 | Class II | StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is... | Abbott Vascular | MGB | |
| Z-2592-2017 | Class II | Proteus 235 | Ion Beam Applications S.A. | LHN | |
| Z-1877-2017 | Class II | ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number... | Cardiovascular Systems Incorporated | MCW | |
| Z-1694-2017 | Class II | SynchroMed II implantable drug infusion pump, Model 8637-40, | Medtronic Neuromodulation | LKK | |
| Z-1413-2017 | Class II | RSP Impaction Fixture | Encore Medical, LP | HWA | |
| Z-1412-2017 | Class II | Turon Impaction Fixture | Encore Medical, LP | HWA | |
| Z-1400-2017 | Class II | Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF... | Remel Inc | LKA | |
| Z-1465-2017 | Class II | Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No... | Abbott Medical | JOH | |
| Z-2169-2017 | Class III | AIA-PACK TgAb CONTROL SET | Tosoh Bioscience Inc | JZO | |
| Z-2168-2017 | Class III | AIA-PACK TPOAb CONTROL SET | Tosoh Bioscience Inc | JZO | |
| Z-1476-2017 | Class II | BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01 | Medtronic, Inc. | FCG | |
| Z-1475-2017 | Class II | SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01 | Medtronic, Inc. | FCG | |
| Z-1474-2017 | Class II | SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01 | Medtronic, Inc. | FCG | |
| Z-1473-2017 | Class II | SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01 | Medtronic, Inc. | FCG | |
| Z-1472-2017 | Class II | BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01 | Medtronic, Inc. | FCG | |
| Z-1460-2017 | Class II | Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ventilator The... | GE Healthcare | CBK | |
| Z-1453-2017 | Class II | LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer... | LeMaitre Vascular Inc. | DQO | |
| Z-1452-2017 | Class II | LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53 | LeMaitre Vascular Inc. | DQO | |
| Z-1451-2017 | Class II | LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU) REF#... | LeMaitre Vascular Inc. | DQO | |
| Z-1450-2017 | Class II | LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52 | LeMaitre Vascular Inc. | DQO | |
| Z-1449-2017 | Class II | LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU) REF#... | LeMaitre Vascular Inc. | DQO | |
| Z-1448-2017 | Class II | LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF#... | LeMaitre Vascular Inc. | DQO | |
| Z-1447-2017 | Class II | LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF#... | LeMaitre Vascular Inc. | DQO | |
| Z-1446-2017 | Class II | LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50 | LeMaitre Vascular Inc. | DQO | |
| Z-1445-2017 | Class II | LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF #... | LeMaitre Vascular Inc. | DQO | |
| Z-1444-2017 | Class II | LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52 | LeMaitre Vascular Inc. | DQO | |
| Z-1443-2017 | Class II | LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51 | LeMaitre Vascular Inc. | DQO | |
| Z-1442-2017 | Class II | LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50 | LeMaitre Vascular Inc. | DQO |