Medical DeviceOct 5, 2016
Zyno Medical Administration Set, Sterile recall — FDA Z-2893-2016
Administration Set potential filter leaking
Class IIFDA: TerminatedZyno Medical LLC
28,535medical device recall records
2,363FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1034
28,535 detailed records are currently available in this category.
Medical DeviceOct 5, 2016
Zyno Medical Administration Set Sterile recall — FDA Z-2896-2016
Administration Set potential filter leaking
Class IIFDA: TerminatedZyno Medical LLC
Medical DeviceOct 5, 2016
Zyno Medical Administration Set, Sterile recall — FDA Z-2895-2016
Administration Set potential filter leaking
Class IIFDA: TerminatedZyno Medical LLC
Medical DeviceOct 5, 2016
EKOS The EKOS cart has the catalog number 700-60101 recall — FDA Z-2890-2016
Casters on the EKOS carts may be missing washers which can cause premature wear and dislodgement of the casters/wheels leading to failure.
Class IIFDA: TerminatedEKOS Corporation
Medical DeviceOct 5, 2016
ETHICON MERSILENE" Tape recall — FDA Z-2889-2016
ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature) products are being recalled since a group of MERSILENE" Tape product codes are…
Class IIFDA: TerminatedEthicon, Inc.
Medical DeviceOct 5, 2016
The Anspach Effort Light Adaptor for Small Battery Drive and Small Battery Drive II recall — FDA Z-2783-2016
There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst.
Class IFDA: TerminatedThe Anspach Effort, Inc.
Medical DeviceOct 5, 2016
The Anspach Effort Adaptor for Small Battery Drive and Small Battery Drive II recall — FDA Z-2784-2016
There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst.
Class IFDA: TerminatedThe Anspach Effort, Inc.
Medical DeviceOct 5, 2016
Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2 recall — FDA Z-2885-2016
The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported…
Class IIFDA: TerminatedSpacelabs Healthcare Inc.
Medical DeviceOct 5, 2016
CareFusion 303 Alaris Syringe Module Model 8110 with software version 9.15 The Alaris recall — FDA Z-2879-2016
A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate to another.
Class IIFDA: TerminatedCareFusion 303, Inc.
Medical DeviceOct 5, 2016
Trividia Health TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with recall — FDA Z-2880-2016
Product gives incorrect low blood glucose levels.
Class IIFDA: OngoingTrividia Health
Medical DeviceOct 5, 2016
Microgenics DRI Salicylate Serum Tox Assay, Catalog number 0977 recall — FDA Z-2884-2016
Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL.
Class IIFDA: TerminatedMicrogenics Corporation
Medical DeviceOct 5, 2016
Zyno Medical Administration Set, Sterile recall — FDA Z-2894-2016
Administration Set potential filter leaking
Class IIFDA: TerminatedZyno Medical LLC
Medical DeviceSep 28, 2016
Integra LifeSciences Corp. d.b.a. Integra Pain PHS Spinal Tray 24G Gertie Marx, Catalogue recall — FDA Z-2868-2016
Integra LifeSciences has recently identified that one lot of Spinal Tray 24 G Gertie Marx Catalogue # 899379 was shipped containing the 24 G Gertie Marx needle without an introducer.
Class IIFDA: TerminatedIntegra LifeSciences Corp. d.b.a. Integra Pain…
Medical DeviceSep 28, 2016
AMO TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No recall — FDA Z-2859-2016
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Class IIFDA: TerminatedAbbott Medical Optics Inc. (AMO)
Medical DeviceSep 28, 2016
Invivo Philips Expression Information Portal (IP5) Model 865471 recall — FDA Z-2867-2016
Frozen Display Numerics and Disabled Menu Keys after extended run time. This customer notification was sent August 22, 2014.
Class IIFDA: TerminatedInvivo Corporation
Medical DeviceSep 28, 2016
The Anspach Effort G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M recall — FDA Z-2838-2016
The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503.
Class IIFDA: TerminatedThe Anspach Effort, Inc.
Medical DeviceSep 28, 2016
Smith & Nephew RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that recall — FDA Z-2848-2016
Sterility seal integrity failures on the Renasys Sterile Transparent Film
Class IIFDA: OngoingSmith & Nephew, Inc.
Medical DeviceSep 28, 2016
Hospira LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number recall — FDA Z-2873-2016
Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this…
Class IIFDA: TerminatedHospira Inc.
Medical DeviceSep 28, 2016
AMO TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No recall — FDA Z-2861-2016
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Class IIFDA: TerminatedAbbott Medical Optics Inc. (AMO)
Medical DeviceSep 28, 2016
Hospira LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or recall — FDA Z-2874-2016
Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this…
Class IIFDA: TerminatedHospira Inc.
Medical DeviceSep 28, 2016
AMO TECNIS Symfony Extended Range of Vision IOL, Model No recall — FDA Z-2857-2016
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Class IIFDA: TerminatedAbbott Medical Optics Inc. (AMO)
Medical DeviceSep 28, 2016
AMO SENSAR Foldable IOL with OptiEdge Design, Model No recall — FDA Z-2855-2016
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Class IIFDA: TerminatedAbbott Medical Optics Inc. (AMO)
Medical DeviceSep 28, 2016
The Anspach Effort G1 Dissection Tool - 3mm FLUTED BALL recall — FDA Z-2839-2016
The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503.
Class IIFDA: TerminatedThe Anspach Effort, Inc.
Medical DeviceSep 28, 2016
Ormco/Sybronendo Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex recall — FDA Z-2836-2016
SybronEndo is recalling the Sealapex Xpress because it was labeled with an incorrect expiration date of 2017-11 while the syringe was labeled with the correct expiration date of 2016-11.
Class IIFDA: TerminatedOrmco/Sybronendo
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.