Medical DeviceJun 1, 2016
American Surgical Uniqcot 1/2" x 3" Ref Number: 67-09 Product Usage: Neurosurgical and recall — FDA Z-1797-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
28,992medical device recall records
2,381FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1077
28,992 detailed records are currently available in this category.
Medical DeviceJun 1, 2016
Biomet Various trauma and sports medicine instruments and implants. guide, surgical recall — FDA Z-1815-2016
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product…
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceJun 1, 2016
American Surgical Tonsil Sponges 1" Large Ref Number: 50-01 Product Usage: Neurosurgical and recall — FDA Z-1763-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
GE Medical Systems GE Healthcare, Discovery IGS 730 recall — FDA Z-1706-2016
Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional…
Class IIFDA: TerminatedGE Medical Systems, LLC
Medical DeviceJun 1, 2016
American Surgical Company Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product recall — FDA Z-1811-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceMay 25, 2016
Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended recall — FDA Z-1686-2016
A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
Class IIFDA: TerminatedDiamedix Corporation
Medical DeviceMay 25, 2016
Zimmer Manufacturing B.V VersaFx Femoral Fixation System Hex head compression screw 4.7 mm recall — FDA Z-1682-2016
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Class IIFDA: TerminatedZimmer Manufacturing B.V.
Medical DeviceMay 25, 2016
The Anspach Effort ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM recall — FDA Z-1668-2016
Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size.
Class IIFDA: TerminatedThe Anspach Effort, Inc.
Medical DeviceMay 25, 2016
Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure recall — FDA Z-1687-2016
A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
Class IIFDA: TerminatedDiamedix Corporation
Medical DeviceMay 25, 2016
Zimmer Manufacturing B.V ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter recall — FDA Z-1681-2016
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Class IIFDA: TerminatedZimmer Manufacturing B.V.
Medical DeviceMay 25, 2016
Monteris Medical NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile recall — FDA Z-1614-2016
Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT procedure, with resulting introduction of C02 into the patient's brain.
Class IFDA: TerminatedMonteris Medical Corp
Medical DeviceMay 25, 2016
Alcon Research 23G and 25G Constellation Totalplus Paks provides access into the posterior recall — FDA Z-1693-2016
The product has potential to leak beyond their design specification.
Class IIFDA: TerminatedAlcon Research, Ltd.
Medical DeviceMay 25, 2016
Alcon Research Custom Paks containing 23G and 25G valved trocar cannula provide access into recall — FDA Z-1694-2016
The product has potential to leak beyond their design specification.
Class IIFDA: TerminatedAlcon Research, Ltd.
Medical DeviceMay 25, 2016
Zimmer Manufacturing B.V Trilogy self-tapping bone screw Bone screw 4.5x25 selftap recall — FDA Z-1684-2016
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Class IIFDA: TerminatedZimmer Manufacturing B.V.
Medical DeviceMay 25, 2016
Siemens Healthcare Diagnostics ADVIA Chemistry Triglyceride_2, concentrated recall — FDA Z-1670-2016
Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c) does not meet Instructions For Use (IFU) linearity claims at the upper limit of…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 25, 2016
Medtronic Navigation Visualase Cooled Laser Applicator System (VCLAS) recall — FDA Z-1672-2016
Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.
Class IIFDA: TerminatedMedtronic Navigation, Inc.
Medical DeviceMay 25, 2016
Valeant Pharmacueticals International Orapharma (Onpharma) Onset Mixing Pen Rx only recall — FDA Z-1699-2016
It has been determined that the Onset Mixing Pen has an optimal use period of 18 months from start of use. However, the current labeling and IFU does not stipulate this time period.
Class IIFDA: TerminatedValeant Pharmacueticals International
Medical DeviceMay 25, 2016
Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the eye recall — FDA Z-1692-2016
The product has potential to leak beyond their design specification.
Class IIFDA: TerminatedAlcon Research, Ltd.
Medical DeviceMay 25, 2016
Zimmer Manufacturing B.V M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm recall — FDA Z-1678-2016
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Class IIFDA: TerminatedZimmer Manufacturing B.V.
Medical DeviceMay 25, 2016
AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257 recall — FDA Z-1671-2016
Under certain conditions, mass spectrometers may report incorrect quantitative results.
Class IIFDA: TerminatedAb Sciex
Medical DeviceMay 25, 2016
The Anspach Effort ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM recall — FDA Z-1667-2016
Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size.
Class IIFDA: TerminatedThe Anspach Effort, Inc.
Medical DeviceMay 25, 2016
Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length recall — FDA Z-1677-2016
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Class IIFDA: TerminatedZimmer Manufacturing B.V.
Medical DeviceMay 25, 2016
Alcon Research LenSx Laser System recall — FDA Z-1688-2016
Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation, which manifests as an…
Class IIFDA: TerminatedAlcon Research, Ltd.
Medical DeviceMay 25, 2016
Lumenis M22 System recall — FDA Z-1669-2016
Lumenis Ltd Announces a Field Action of the M22 IPL Acne Filters for the Lumenis M22 IPL Hand Piece due to the Risk of Superficial Burns When Using the Device.
Class IIFDA: TerminatedLumenis Ltd
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.