Medical DeviceJun 8, 2016
Covidien Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" recall — FDA Z-1849-2016
Compromised sterility due to breach of barrier
Class IIFDA: TerminatedCovidien LLC
28,992medical device recall records
2,381FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1070
28,992 detailed records are currently available in this category.
Medical DeviceJun 8, 2016
Skytron, Div. The KMW Group EZ Slide Battery/line powered hydraulic table with removable leg recall — FDA Z-1844-2016
The potential exists within the identified tables that incorrectly manufactured parts have been used in assembly. If a table is found to have these incorrectly manufactured parts, it is…
Class IIFDA: TerminatedSkytron, Div. The KMW Group, Inc.
Medical DeviceJun 8, 2016
Windstone Medical Packaging Laparotomy Pack Latex Free, part number 007725-7 recall — FDA Z-1869-2016
These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.
Class IIFDA: TerminatedWindstone Medical Packaging, Inc.
Medical DeviceJun 8, 2016
Affymetrix CytoScan Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash recall — FDA Z-1909-2016
During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment.
Class IIIFDA: TerminatedAffymetrix Inc.
Medical DeviceJun 8, 2016
Exactech Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem recall — FDA Z-1903-2016
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceJun 8, 2016
Exactech Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. recall — FDA Z-1901-2016
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceJun 8, 2016
Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments recall — FDA Z-1867-2016
Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.
Class IIFDA: TerminatedIntegra LifeSciences Corp.
Medical DeviceJun 8, 2016
Siemens Healthcare Diagnostics Dimension Vista 500 Intelligent Lab System running on recall — FDA Z-1885-2016
Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics Inc.
Medical DeviceJun 8, 2016
Covidien Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" recall — FDA Z-1853-2016
Compromised sterility due to breach of barrier
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJun 8, 2016
Covidien Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number recall — FDA Z-1859-2016
Compromised sterility due to breach of barrier
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJun 8, 2016
Greatbatch Medical Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver recall — FDA Z-1883-2016
Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of…
Class IIFDA: TerminatedGreatbatch Medical
Medical DeviceJun 8, 2016
Ventlab STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide recall — FDA Z-1880-2016
Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should be purple when not in use. The yellow indicates a 5% CO2 level, cardiac massage and…
Class IIFDA: TerminatedVentlab LLC
Medical DeviceJun 8, 2016
Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments recall — FDA Z-1866-2016
Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.
Class IIFDA: TerminatedIntegra LifeSciences Corp.
Medical DeviceJun 8, 2016
Siemens Healthcare Diagnostics Dimension Vista 1500 Intelligent Lab System running on recall — FDA Z-1886-2016
Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics Inc.
Medical DeviceJun 8, 2016
Philips Medical Systems (Cleveland) Ingenuity Core 128 Computed Tomography X-ray Systems recall — FDA Z-1874-2016
The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceJun 8, 2016
Integra York PA Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405 recall — FDA Z-1841-2016
One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle.
Class IIFDA: TerminatedIntegra York PA, Inc.
Medical DeviceJun 8, 2016
Intuitive Surgical SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10 recall — FDA Z-1837-2016
Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is…
Class IIFDA: TerminatedIntuitive Surgical, Inc.
Medical DeviceJun 8, 2016
Windstone Medical Packaging General Surgery Pack, part number 006880-3 recall — FDA Z-1870-2016
These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.
Class IIFDA: TerminatedWindstone Medical Packaging, Inc.
Medical DeviceJun 8, 2016
Olympus Corporation of the Americas EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF recall — FDA Z-1845-2016
New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised manual cleaning and high level disinfection procedures they plan to implement as well as a new…
Class IIFDA: TerminatedOlympus Corporation of the Americas
Medical DeviceJun 8, 2016
Medscience AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 recall — FDA Z-1843-2016
During an FDA inspection it was found that the products are marketed without a cleared 510k.
Class IIFDA: TerminatedMedscience Inc.
Medical DeviceJun 8, 2016
Covidien Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" recall — FDA Z-1852-2016
Compromised sterility due to breach of barrier
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJun 8, 2016
Exactech Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem recall — FDA Z-1904-2016
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceJun 8, 2016
Intuitive Surgical SEAL,IS4000 PORTS,5MM-8MM,BOX of 10 recall — FDA Z-1836-2016
Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is…
Class IIFDA: TerminatedIntuitive Surgical, Inc.
Medical DeviceJun 8, 2016
Covidien Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" recall — FDA Z-1851-2016
Compromised sterility due to breach of barrier
Class IIFDA: TerminatedCovidien 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.