Medical DeviceAug 5, 2020
TELEFLEX MEDICAL Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) recall — FDA Z-2728-2020
Breaking at the point of a welded joint
Class IIFDA: TerminatedTELEFLEX MEDICAL Inc.
Latest records
Latest recalls — page 989
The newest recall records with useful source details are listed here.
Medical DeviceAug 5, 2020
TELEFLEX MEDICAL Rusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (each) recall — FDA Z-2729-2020
Breaking at the point of a welded joint
Class IIFDA: TerminatedTELEFLEX MEDICAL Inc.
Medical DeviceAug 5, 2020
Shanghai United Imaging Healthcare Co Computed Tomography X-ray System recall — FDA Z-2705-2020
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
Class IIFDA: OngoingShanghai United Imaging Healthcare Co., Ltd.
Medical DeviceAug 5, 2020
Medline Industries ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN recall — FDA Z-2724-2020
There are reports of the suction catheter coming apart from the device assembly during use.
Class IIFDA: OngoingMedline Industries Inc.
Medical DeviceAug 5, 2020
Hill-Rom Centrella Smart+ Bed, Catalog No recall — FDA Z-2738-2020
Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user injury.
Class IIFDA: TerminatedHill-Rom, Inc.
Medical DeviceAug 5, 2020
TELEFLEX MEDICAL Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) recall — FDA Z-2730-2020
Breaking at the point of a welded joint
Class IIFDA: TerminatedTELEFLEX MEDICAL Inc.
Medical DeviceAug 5, 2020
Abbott Gmbh & Co. KG Alinity ci series System Control Module (SCM) recall — FDA Z-2701-2020
Quality Control results were not properly evaluated for QC failures.
Class IIFDA: TerminatedAbbott Gmbh & Co. KG
Medical DeviceAug 5, 2020
Synthes MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation recall — FDA Z-2698-2020
One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop…
Class IIFDA: TerminatedSynthes, Inc.
Medical DeviceAug 5, 2020
TELEFLEX MEDICAL Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product recall — FDA Z-2732-2020
Breaking at the point of a welded joint
Class IIFDA: TerminatedTELEFLEX MEDICAL Inc.
Medical DeviceAug 5, 2020
Shanghai United Imaging Healthcare Co Computed Tomography X-ray System recall — FDA Z-2703-2020
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
Class IIFDA: OngoingShanghai United Imaging Healthcare Co., Ltd.
Medical DeviceAug 5, 2020
Arthrex Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product recall — FDA Z-2733-2020
Screws provided in packaging are 5mm shorter than intended
Class IIFDA: TerminatedArthrex, Inc.
Medical DeviceAug 5, 2020
Resource Optimization & Innovation regard Migrating Indicator, STEAM Migrating Indicator recall — FDA Z-2699-2020
The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go into the "accept" window at the time of use.
Class IIFDA: TerminatedResource Optimization & Innovation LLC
Medical DeviceAug 5, 2020
Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for recall — FDA Z-2702-2020
The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve
Class IIFDA: OngoingSmith & Nephew, Inc.
Medical DeviceAug 5, 2020
Richard Wolf GmbH Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) recall — FDA Z-2706-2020
Tube material of a smaller diameter was used.
Class IIFDA: TerminatedRichard Wolf GmbH
Medical DeviceAug 5, 2020
Medline Industries ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr recall — FDA Z-2725-2020
There are reports of the suction catheter coming apart from the device assembly during use.
Class IIFDA: OngoingMedline Industries Inc.
Medical DeviceAug 5, 2020
TELEFLEX MEDICAL Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) recall — FDA Z-2727-2020
Breaking at the point of a welded joint
Class IIFDA: TerminatedTELEFLEX MEDICAL Inc.
Medical DeviceAug 5, 2020
Shanghai United Imaging Healthcare Co Computed Tomography X-ray System recall — FDA Z-2704-2020
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
Class IIFDA: OngoingShanghai United Imaging Healthcare Co., Ltd.
Medical DeviceAug 5, 2020
Synthes Produktions GmbH MatrixMIDFACE Screws - Product Usage: The intended use for this recall — FDA Z-2739-2020
One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a body clip etched with a 3 (representing 3mm) when it should have been packaged with body clip…
Class IIFDA: TerminatedSynthes Produktions GmbH
Medical DeviceAug 5, 2020
Hill-Rom Progressa Bed, Catalog No recall — FDA Z-2737-2020
Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user injury.
Class IIFDA: TerminatedHill-Rom, Inc.
Medical DeviceAug 5, 2020
TELEFLEX MEDICAL Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) recall — FDA Z-2731-2020
Breaking at the point of a welded joint
Class IIFDA: TerminatedTELEFLEX MEDICAL Inc.
Medical DeviceAug 5, 2020
Medtronic Navigation StealthStation" S7 System with Polaris Spectra Camera part number PSU recall — FDA Z-2707-2020
There is a potential for specific camera units to be affected by a characterization issue during manufacturing that results in inaccurate navigation while utilizing both the active and…
Class IIFDA: TerminatedMedtronic Navigation, Inc.
Medical DeviceAug 5, 2020
OrthoPediatrics Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 recall — FDA Z-2742-2020
Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device
Class IIFDA: OngoingOrthoPediatrics Corp
Medical DeviceAug 5, 2020
Ion Beam Applications S.A Proteus 235 The Proton Therapy System - Proteus 235 recall — FDA Z-2715-2020
IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
Class IIFDA: TerminatedIon Beam Applications S.A.
Medical DeviceAug 5, 2020
TELEFLEX MEDICAL Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) recall — FDA Z-2726-2020
Breaking at the point of a welded joint
Class IIFDA: TerminatedTELEFLEX MEDICAL Inc.
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