Medical DeviceDec 26, 2018
Konica Minolta Healthcare, Americas Bucky Stand SU-4000 Input 2017.11.17 recall — FDA Z-0659-2019
Unintentional U-Arm movement
Class IIFDA: TerminatedKonica Minolta Healthcare, Americas, Inc.
26,628medical device recall records
2,311FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.778 records
Database records
Records — page 759
26,628 detailed records are currently available in this category.
Medical DeviceDec 26, 2018
Ortho-Clinical Diagnostics VITROS 5600 Integrated System, Version 3.3.1 & below For use in recall — FDA Z-0650-2019
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Class IIFDA: TerminatedOrtho-Clinical Diagnostics
Medical DeviceDec 26, 2018
Deerfield Imaging IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) recall — FDA Z-0647-2019
Table may drift in the roll position while in use
Class IIFDA: TerminatedDeerfield Imaging, Inc.
Medical DeviceDec 26, 2018
Cardinal Health 200 Protexis Neoprene Surgical Glove, Size 6.0 This powder-free sterile recall — FDA Z-0632-2019
Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene…
Class IIFDA: TerminatedCardinal Health 200, LLC
Medical DeviceDec 26, 2018
Cardinal Health 200 Protexis Neoprene Surgical Glove, Size 8.0 This powder-free sterile recall — FDA Z-0636-2019
Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene…
Class IIFDA: TerminatedCardinal Health 200, LLC
Medical DeviceDec 19, 2018
Leoni Fiber Optics GmbH Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve recall — FDA Z-0581-2019
A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised…
Class IIFDA: TerminatedLeoni Fiber Optics GmbH
Medical DeviceDec 19, 2018
Tosoh Bioscience Hemoglobin A1c Control, Part no. 220232 for use as quality control material recall — FDA Z-0601-2019
Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days product stability claim. If degradation of these controls occurs, P00 peaks may be…
Class IIIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceDec 19, 2018
CIVCO Medical Instruments Co SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08 recall — FDA Z-0567-2019
SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSite L25 series transducers. Mfg for:
Class IIFDA: TerminatedCIVCO Medical Instruments Co., Inc.
Medical DeviceDec 19, 2018
GE Healthcare PROCARE B20 Patient Monitor, V1 recall — FDA Z-0583-2019
Patient monitors may restart due to network overload caused by network configuration.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceDec 19, 2018
The Binding Site Group Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device recall — FDA Z-0604-2019
Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified…
Class IIFDA: TerminatedThe Binding Site Group, Ltd.
Medical DeviceDec 19, 2018
Zimmer Biomet Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394 recall — FDA Z-0590-2019
Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceDec 19, 2018
Leoni Fiber Optics GmbH Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension recall — FDA Z-0577-2019
A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised…
Class IIFDA: TerminatedLeoni Fiber Optics GmbH
Medical DeviceDec 19, 2018
Leoni Fiber Optics GmbH Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension recall — FDA Z-0578-2019
A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised…
Class IIFDA: TerminatedLeoni Fiber Optics GmbH
Medical DeviceDec 19, 2018
GE Healthcare Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting recall — FDA Z-0606-2019
When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could…
Class IIFDA: CompletedGE Healthcare, LLC
Medical DeviceDec 19, 2018
Leoni Fiber Optics GmbH Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension recall — FDA Z-0580-2019
A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised…
Class IIFDA: TerminatedLeoni Fiber Optics GmbH
Medical DeviceDec 19, 2018
CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives recall — FDA Z-0576-2019
CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives.
Class IIFDA: TerminatedCIVCO Medical Instruments Co., Inc.
Medical DeviceDec 19, 2018
Howmedica Osteonics Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant recall — FDA Z-0605-2019
The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively.
Class IIFDA: TerminatedHowmedica Osteonics Corp.
Medical DeviceDec 19, 2018
CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with recall — FDA Z-0565-2019
CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers.
Class IIFDA: TerminatedCIVCO Medical Instruments Co., Inc.
Medical DeviceDec 19, 2018
Heartware Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US recall — FDA Z-0582-2019
HVAD Battery Charger units manufactured with wrong inductors.
Class IIFDA: TerminatedHeartware, Inc.
Medical DeviceDec 19, 2018
CIVCO Medical Instruments Co SonoSite Needle Guide Bracket, REF numbers P06013-06 and recall — FDA Z-0566-2019
SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transducers.
Class IIFDA: TerminatedCIVCO Medical Instruments Co., Inc.
Medical DeviceDec 19, 2018
Neotract UroLift System REF recall — FDA Z-0598-2019
Upon implant deployment, the Capsular Tab may not be delivered as the needle is retracted. In this failure mode, the needle is deployed into the prostate and retracted, leaving no implant…
Class IIFDA: TerminatedNeotract Inc.
Medical DeviceDec 19, 2018
ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip recall — FDA Z-0589-2019
Inspection process at the manufacturer found nonwoven material was used in specific lots of product that may break wile in use during the patient/resident transfer. Patient/resident might…
Class IIFDA: TerminatedARJOHUNTLEIGH POLSKA Sp. z.o.o.
Medical DeviceDec 19, 2018
St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE recall — FDA Z-0593-2019
The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed with MP35N instead of the required 90/10 platinum-iridium.
Class IIFDA: TerminatedSt. Jude Medical, Inc.
Medical DeviceDec 19, 2018
GE Healthcare B20i Patient Monitor and B20i V2 Patient Monitor recall — FDA Z-0585-2019
Patient monitors may restart due to network overload caused by network configuration.
Class IIFDA: OngoingGE Healthcare, LLC
How to use this medical device recall index
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.