Medical DeviceAug 22, 2018
Mako Surgical Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS recall — FDA Z-2794-2018
Out of tolerance.
Class IIFDA: TerminatedMako Surgical Corporation
Latest records
Latest recalls — page 1375
The newest recall records with useful source details are listed here.
Medical DeviceAug 22, 2018
ICU Medical de Mexico, S.A. de C.V 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave recall — FDA Z-2804-2018
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for…
Class IIFDA: TerminatedICU Medical de Mexico, S.A. de C.V.
Medical DeviceAug 22, 2018
NxStage Express Fluid Warmer recall — FDA Z-2793-2018
There is a potential risk of electrical fire when fluid leaks into the power receptacle on the back of the warmer. The risk exists any time the warmer is plugged in. The firm has received 7…
Class IIFDA: TerminatedNxStage Medical, Inc.
Medical DeviceAug 22, 2018
Cook VentriClear Ventricular Drainage Catheter Set, Cat recall — FDA Z-2791-2018
This lot of VentriClear failed endotoxin testing. Potential adverse events include immune responses ranging from non-specific febrile reaction to life-threatening systemic inflammatory…
Class IIFDA: TerminatedCook Inc.
Medical DeviceAug 22, 2018
ICU Medical de Mexico, S.A. de C.V 11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave recall — FDA Z-2814-2018
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for…
Class IIFDA: TerminatedICU Medical de Mexico, S.A. de C.V.
Medical DeviceAug 22, 2018
DRG Instruments GmbH Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative recall — FDA Z-2836-2018
Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1.
Class IIFDA: TerminatedDRG Instruments GmbH
Medical DeviceAug 22, 2018
Beekley O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography recall — FDA Z-2830-2018
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
Class IIFDA: TerminatedBeekley Corporation
Medical DeviceAug 22, 2018
Tosoh Bioscience G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560 recall — FDA Z-2745-2018
HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Customers should exercise caution when reviewing chromatograms and ensure that Flag 43 is…
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceAug 22, 2018
Guangzhou Improve Medical Instruments Co Improve Blood Collection Sets with Multiple Sample recall — FDA Z-2790-2018
Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip.
Class IIFDA: OngoingGuangzhou Improve Medical Instruments Co., Ltd.
Medical DeviceAug 22, 2018
Siemens Medical Solutions USA Artis Q. angiography system recall — FDA Z-2747-2018
Potential hardware issue which may cause thermal effects and possible damage to system parts.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceAug 22, 2018
Cypress Medical Products Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118 Product recall — FDA Z-2828-2018
The firm is recalling one lot of McKesson Powder Free Vinyl Exam Gloves because a sample of product from that lot did not meet certain release specifications. It is possible that certain…
Class IIFDA: TerminatedCypress Medical Products LLC
Medical DeviceAug 22, 2018
ICU Medical de Mexico, S.A. de C.V PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port recall — FDA Z-2805-2018
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for…
Class IIFDA: TerminatedICU Medical de Mexico, S.A. de C.V.
Medical DeviceAug 22, 2018
Guangzhou Wondfo Biotech Co TCube One Step Multi-Drug Oral Fluid Test Cube recall — FDA Z-2787-2018
GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use of the saliva collection device…
Class IIFDA: OngoingGuangzhou Wondfo Biotech Co., Ltd.
Medical DeviceAug 22, 2018
Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system recall — FDA Z-2743-2018
Component of the Lap-Band system was missing from the package
Class IIFDA: TerminatedApollo Endosurgery Inc.
Medical DeviceAug 22, 2018
Guangzhou Wondfo Biotech Co TCube One Step Multi-Drug Oral Fluid Test Cube recall — FDA Z-2789-2018
GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use of the saliva collection device…
Class IIFDA: OngoingGuangzhou Wondfo Biotech Co., Ltd.
Medical DeviceAug 22, 2018
ICU Medical de Mexico, S.A. de C.V 30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave recall — FDA Z-2799-2018
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for…
Class IIFDA: TerminatedICU Medical de Mexico, S.A. de C.V.
Medical DeviceAug 22, 2018
Sorin Platinium CRT-D 1741 DF-4, Sterile EO recall — FDA Z-2825-2018
Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrillation…
Class IIFDA: TerminatedSorin CRM SAS
Medical DeviceAug 22, 2018
Siemens Medical Solutions USA ARTIS Pheno Model 10849000 recall — FDA Z-2748-2018
Potential hardware issue which may cause thermal effects and possible damage to system parts.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceAug 22, 2018
Hamilton Medical AG Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is recall — FDA Z-2795-2018
An out of specification component on the control board may cause the ventilator to open the inspiratory channel and the expiratory valve. The ventilator will shut down and an emergency…
Class IIFDA: TerminatedHamilton Medical AG
Medical DeviceAug 22, 2018
ICU Medical de Mexico, S.A. de C.V 10" Smallbore Ext Set w/6-Port NanoClave Manifold recall — FDA Z-2815-2018
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for…
Class IIFDA: TerminatedICU Medical de Mexico, S.A. de C.V.
Medical DeviceAug 22, 2018
ICU Medical de Mexico, S.A. de C.V 43 cm (17") Smallbore Ext Set w/3-Port NanoClave recall — FDA Z-2802-2018
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for…
Class IIFDA: TerminatedICU Medical de Mexico, S.A. de C.V.
Medical DeviceAug 22, 2018
Intuitive Surgical The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope recall — FDA Z-2835-2018
An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have…
Class IIFDA: OngoingIntuitive Surgical, Inc.
Medical DeviceAug 22, 2018
Terumo Cardiovascular Systems Monitor with one Blood Parameter Module and one HSat Probe recall — FDA Z-2751-2018
H/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat population, which has resulted in an increase of Hybrids failing the H/Sat Color Chip Test which is an automated…
Class IIFDA: TerminatedTerumo Cardiovascular Systems Corporation
Medical DeviceAug 22, 2018
Zimmer Biomet ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item recall — FDA Z-2821-2018
Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement…
Class IIFDA: TerminatedZimmer Biomet, Inc.
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