Medical DeviceDec 23, 2015
Insulet OmniPod, Insulin Management System (US) recall — FDA Z-0393-2016
Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
Class IFDA: TerminatedInsulet Corporation
29,496medical device recall records
2,407FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1129
29,496 detailed records are currently available in this category.
Medical DeviceDec 23, 2015
Teleflex Medical Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson recall — FDA Z-0419-2016
Product is being recalled due to complaints that the inspiratory and expiratory tubes are transposed.
Class IIFDA: TerminatedTeleflex Medical
Medical DeviceDec 23, 2015
Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system recall — FDA Z-0407-2016
During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan.
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceDec 23, 2015
Philips Healthcare Ingenuity CT Computed Tomography X-ray system recall — FDA Z-0408-2016
During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan.
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceDec 23, 2015
Edwards Lifesciences Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22 recall — FDA Z-0446-2016
Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (clearance) of the devices.
Class IIFDA: TerminatedEdwards Lifesciences, LLC
Medical DeviceDec 23, 2015
Philips Healthcare Brilliance 64 Computed Tomography X-ray system recall — FDA Z-0405-2016
During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan.
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceDec 23, 2015
Draeger Medical Perseus A500 Anesthesia Workstation, MK06000 recall — FDA Z-0360-2016
There is a potential problem with the device main power switch of the Perseus A500 Anesthesia Workstation. The device power switch may spontaneously fail during use, causing one of the…
Class IFDA: TerminatedDraeger Medical, Inc.
Medical DeviceDec 23, 2015
MOOG Medical Devices Group Catalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery recall — FDA Z-0415-2016
Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector.
Class IIFDA: TerminatedMOOG Medical Devices Group
Medical DeviceDec 23, 2015
Verathon GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007 recall — FDA Z-0420-2016
Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due to inadequate bonding of the silicone adhesive affixing the halves of the blade. The…
Class IIFDA: TerminatedVerathon, Inc.
Medical DeviceDec 23, 2015
bioMerieux MYLA MASTER DVD V4.1 CLI Product Usage: MYLA is a computer application recall — FDA Z-0429-2016
MYLA software connected to a Laboratory Information System (LIS) and a VITEK 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.
Class IIFDA: TerminatedbioMerieux, Inc.
Medical DeviceDec 23, 2015
bioMerieux MYLA MASTER DVD V4.0 CLI Product Usage: MYLA is a computer application recall — FDA Z-0428-2016
MYLA software connected to a Laboratory Information System (LIS) and a VITEK 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.
Class IIFDA: TerminatedbioMerieux, Inc.
Medical DeviceDec 23, 2015
Beckman Coulter UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0 recall — FDA Z-0432-2016
Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH systems allows the creation of…
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceDec 23, 2015
GE Medical Systems GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems recall — FDA Z-0413-2016
GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320…
Class IIFDA: TerminatedGE Medical Systems, LLC
Medical DeviceDec 16, 2015
Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM recall — FDA Z-0373-2016
The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left…
Class IIFDA: TerminatedSmith & Nephew, Inc.
Medical DeviceDec 16, 2015
Implant Direct Sybron Manufacturing DGDE, DirectGuide Drill Extender recall — FDA Z-0396-2016
Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill.
Class IIFDA: TerminatedImplant Direct Sybron Manufacturing, LLC
Medical DeviceDec 16, 2015
Edwards Lifesciences Thin-Flex Venous Cannula recall — FDA Z-0398-2016
Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8…
Class IIFDA: TerminatedEdwards Lifesciences, LLC
Medical DeviceDec 16, 2015
Powers Medical Devices The "Pacifier Activated Lullaby" (PAL) System composed of three major recall — FDA Z-0395-2016
PAL unit has undergone significant technological changes since the previous 510(k) and labeling is not consistent with the cleared indications of the 510(k).
Class IIFDA: OngoingPowers Medical Devices, LLC
Medical DeviceDec 16, 2015
LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64 recall — FDA Z-0384-2016
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Class IIFDA: TerminatedLeMaitre Vascular, Inc.
Medical DeviceDec 16, 2015
Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM recall — FDA Z-0372-2016
The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left…
Class IIFDA: TerminatedSmith & Nephew, Inc.
Medical DeviceDec 16, 2015
STERILMED Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed recall — FDA Z-0404-2016
Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed cannot assure the sterility of all units in the recalled lots. The introduction of non-sterile…
Class IIFDA: TerminatedSTERILMED, Inc.
Medical DeviceDec 16, 2015
Philips Medical Systems (Cleveland) Brilliance 64 Computed Tomography X-Ray System, Model recall — FDA Z-0409-2016
Multiple software defects which could impact the performance or reliability of the system. These impacts include, but are not limited to: error messages which prevent operation, incorrect…
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceDec 16, 2015
LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38 recall — FDA Z-0379-2016
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Class IIFDA: TerminatedLeMaitre Vascular, Inc.
Medical DeviceDec 16, 2015
Olympus ENDOEYE HD II Video Telescopes recall — FDA Z-0403-2016
A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heating of the ENDOEYE distal end could result in patient or user injury.
Class IIFDA: TerminatedOlympus Corporation of the Americas
Medical DeviceDec 16, 2015
Zimmer Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona recall — FDA Z-0411-2016
Complaints that the ratchet teeth of the tube are not latching onto the rod.
Class IIFDA: TerminatedZimmer, Inc.
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.