Medical DeviceJun 3, 2020
Sonendo GENTLEWAVE REF: FG-002-0001 recall — FDA Z-2162-2020
The console would continue to run for extended period when the foot pedal was released.
Class IIFDA: TerminatedSonendo Inc.
25,676medical device recall records
2,265FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.759 records
Database records
Records — page 606
25,676 detailed records are currently available in this category.
Medical DeviceJun 3, 2020
Boston Scientific Neuromodulation The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number recall — FDA Z-2122-2020
The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed…
Class IIFDA: TerminatedBoston Scientific Neuromodulation Corporation
Medical DeviceJun 3, 2020
Siemens Medical Solutions USA Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model recall — FDA Z-2127-2020
The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceJun 3, 2020
Inpeco S.A FlexLab Automation System used with the following Modules: High Volume recall — FDA Z-2114-2020
The sensors which activate the safety switches may be affected by delayed activation. In 1% of the cases, the response delay can be up to a maximum delay of 2 seconds, instead of 40ms…
Class IIFDA: TerminatedInpeco S.A.
Medical DeviceJun 3, 2020
Biomet Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM recall — FDA Z-2153-2020
Potential presence of elevated endotoxin levels that exceed the specification limit
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceJun 3, 2020
Medtronic Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on recall — FDA Z-2106-2020
Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad or iPod Touch with ios software version 12, 12.1, or 12,2 are likely to experience a shortened…
Class IIFDA: OngoingMedtronic Inc.
Medical DeviceJun 3, 2020
TELEFLEX MEDICAL Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex recall — FDA Z-2129-2020
Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified…
Class IIFDA: OngoingTELEFLEX MEDICAL Inc.
Medical DeviceJun 3, 2020
The Binding Site Group Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx recall — FDA Z-2110-2020
Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid arthritis over recovers by 7% in comparison to the…
Class IIFDA: TerminatedThe Binding Site Group, Ltd.
Medical DeviceJun 3, 2020
Inpeco S.A Accelerator a3600 Automation System used with the following Modules: High Volume recall — FDA Z-2115-2020
The sensors which activate the safety switches may be affected by delayed activation. In 1% of the cases, the response delay can be up to a maximum delay of 2 seconds, instead of 40ms…
Class IIFDA: TerminatedInpeco S.A.
Medical DeviceJun 3, 2020
Inpeco S.A Aptio Automation System with Advia2120LAS Interface Module recall — FDA Z-2142-2020
The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation…
Class IIFDA: TerminatedInpeco S.A.
Medical DeviceJun 3, 2020
Boston Scientific Neuromodulation ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number recall — FDA Z-2119-2020
The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed…
Class IIFDA: TerminatedBoston Scientific Neuromodulation Corporation
Medical DeviceJun 3, 2020
TELEFLEX MEDICAL Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex recall — FDA Z-2130-2020
Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified…
Class IIFDA: OngoingTELEFLEX MEDICAL Inc.
Medical DeviceJun 3, 2020
Siemens Medical Solutions USA ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model recall — FDA Z-2108-2020
If the C-arm leaves its intended travel path due to a fault within the drivetrain, movements may be impacted or impossible and the area of interest cannot be reached. In the event the…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceJun 3, 2020
Abbott Gmbh & Co. KG ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements recall — FDA Z-2117-2020
Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High Sensitivity Troponin I assays (LN 3P25 and LN 2R98) may show interaction when processed…
Class IIFDA: OngoingAbbott Gmbh & Co. KG
Medical DeviceMay 27, 2020
Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for recall — FDA Z-2053-2020
The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not perform the selected function;3) The…
Class IIFDA: TerminatedPhilips North America, LLC
Medical DeviceMay 27, 2020
Baylis Medical Company TorFlex Transseptal Guiding Sheath recall — FDA Z-2069-2020
There is a remote potential for the sterile packaging of lots of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not…
Class IIFDA: TerminatedBaylis Medical Company Inc.
Medical DeviceMay 27, 2020
K2M recall — FDA Z-2009-2020
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Class IIFDA: TerminatedK2M, Inc.
Medical DeviceMay 27, 2020
Cardinal Health Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere recall — FDA Z-2050-2020
Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis…
Class IIFDA: TerminatedCardinal Health Inc.
Medical DeviceMay 27, 2020
Howmedica Osteonics Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 recall — FDA Z-2085-2020
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
Class IIFDA: TerminatedHowmedica Osteonics Corp.
Medical DeviceMay 27, 2020
Applied Medical Resources STEALTH SPRING CLIP 6mm latis (3/4 Force) recall — FDA Z-2036-2020
Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
Class IIFDA: TerminatedApplied Medical Resources Corp
Medical DeviceMay 27, 2020
Skeletal Kinetics Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product recall — FDA Z-2054-2020
Potential product mix-up. The recalling firm has determined that one unit of OsteoVation EX, 3cc that may not have been sterilized was inadvertently packaged as CranioSculpt C, 10cc.
Class IIFDA: TerminatedSkeletal Kinetics, LLC
Medical DeviceMay 27, 2020
Pega Medical Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary recall — FDA Z-2038-2020
The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
Class IIIFDA: TerminatedPega Medical Inc.
Medical DeviceMay 27, 2020
K2M recall — FDA Z-2014-2020
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Class IIFDA: TerminatedK2M, Inc.
Medical DeviceMay 27, 2020
Medline Industries SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product recall — FDA Z-2043-2020
Loose silicone particulate was found to be present on the shaft of the silicone catheters.
Class IIFDA: TerminatedMedline Industries 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.