Medical DeviceAug 26, 2015
Teleflex Bronchial One Lumen Tube - Left recall — FDA Z-2409-2015
Customer complaints reporting that the cobb connector detached from the main connector prior to use.
Class IIFDA: TerminatedTeleflex, Inc.
29,963medical device recall records
2,598FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1161
29,963 detailed records are currently available in this category.
Medical DeviceAug 26, 2015
Winco Care Cliner Standart - Steel Casters Oncology, Dialysis, Hospital Recovery, Home recall — FDA Z-2392-2015
Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Class IIFDA: TerminatedWinco Mfg., LLC
Medical DeviceAug 26, 2015
Stryker Howmedica Osteonics rHead Lateral Stem, Size 1, Do Not Reuse, Sterile recall — FDA Z-2426-2015
Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by…
Class IIFDA: TerminatedStryker Howmedica Osteonics Corp.
Medical DeviceAug 26, 2015
Winco Drop Arm Care Cliner Standard - with Nylon Casters Oncology, Dialysis, Hospital recall — FDA Z-2395-2015
Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Class IIFDA: TerminatedWinco Mfg., LLC
Medical DeviceAug 26, 2015
C.R. Bard Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the recall — FDA Z-2388-2015
Potential breach of the sterile barrier packaging.
Class IIFDA: TerminatedC.R. Bard, Inc.
Medical DeviceAug 26, 2015
Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis, Hospital recall — FDA Z-2396-2015
Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Class IIFDA: TerminatedWinco Mfg., LLC
Medical DeviceAug 26, 2015
CareFusion 303 Alaris Syringe Pump, Model No. 8110 recall — FDA Z-2362-2015
Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syringe module. After the error is cleared on the PCU, the syringe pump is unresponsive to key…
Class IFDA: TerminatedCareFusion 303, Inc.
Medical DeviceAug 26, 2015
Stryker Howmedica Osteonics uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only recall — FDA Z-2427-2015
Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by…
Class IIFDA: TerminatedStryker Howmedica Osteonics Corp.
Medical DeviceAug 26, 2015
Siemens Medical Solutions USA Artis zee/ zeego systems recall — FDA Z-2404-2015
in case a system error occurs and the system enters the "Bypass Fluoro" mode while the X-ray locking function is active, the only way to exit the X-ray locking function, would be to either…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceAug 26, 2015
Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner recall — FDA Z-2391-2015
Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Class IIFDA: TerminatedWinco Mfg., LLC
Medical DeviceAug 26, 2015
Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncology, Dialysis recall — FDA Z-2400-2015
Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Class IIFDA: TerminatedWinco Mfg., LLC
Medical DeviceAug 26, 2015
Winco Care Cliner X-Large - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home recall — FDA Z-2394-2015
Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Class IIFDA: TerminatedWinco Mfg., LLC
Medical DeviceAug 26, 2015
Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873 recall — FDA Z-2417-2015
When the fixation ring is taken off the paper liner there is a potential for fractions of the paper liner's surface coating to stick to the surface of the ring.
Class IIFDA: TerminatedRadiometer America Inc.
Medical DeviceAug 26, 2015
Sedecal S.A RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray recall — FDA Z-2390-2015
Electrostatic energy may be stored in Systems that can cause a short-cicuit which, in turn, can generate an Electomagnetic Pulse which might disturb the electronics of the Digital Motion…
Class IIFDA: TerminatedSedecal S.A.
Medical DeviceAug 26, 2015
Elite Biomedical Solutions Alaris Medley LVP Frame Membrane recall — FDA Z-2371-2015
Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.
Class IFDA: TerminatedElite Biomedical Solutions LLC
Medical DeviceAug 26, 2015
Winco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology, Dialysis, Hospital recall — FDA Z-2399-2015
Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Class IIFDA: TerminatedWinco Mfg., LLC
Medical DeviceAug 26, 2015
Cordis RenLane Renal Denervation Catheter recall — FDA Z-2405-2015
Potential Damage may occur to the helical tip of the RENLANE Renal Denervation Catheter, if the hemostasis valve of the arterial access device is not fully open before insertion or…
Class IIFDA: TerminatedCordis Corporation
Medical DeviceAug 26, 2015
Teleflex Bronchial Double Lumen Tube Set (Left), Sterile recall — FDA Z-2407-2015
Customer complaints reporting that the cobb connector detached from the main connector prior to use.
Class IIFDA: TerminatedTeleflex, Inc.
Medical DeviceAug 26, 2015
Stryker Howmedica Osteonics Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx recall — FDA Z-2430-2015
Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by…
Class IIFDA: TerminatedStryker Howmedica Osteonics Corp.
Medical DeviceAug 26, 2015
Siemens Symbia S Series system, a diagnostic analog or digital detector based planar recall — FDA Z-2435-2015
Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceAug 26, 2015
Winco Nocturnal Elite Care Cliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ recall — FDA Z-2403-2015
Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Class IIFDA: TerminatedWinco Mfg., LLC
Medical DeviceAug 26, 2015
Winco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home recall — FDA Z-2393-2015
Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Class IIFDA: TerminatedWinco Mfg., LLC
Medical DeviceAug 26, 2015
Teleflex Bronchial One Lumen Tube - Right recall — FDA Z-2410-2015
Customer complaints reporting that the cobb connector detached from the main connector prior to use.
Class IIFDA: TerminatedTeleflex, Inc.
Medical DeviceAug 26, 2015
Stryker Howmedica Osteonics Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not recall — FDA Z-2429-2015
Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by…
Class IIFDA: TerminatedStryker Howmedica Osteonics Corp.
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.