Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2020-08-12FDA-DeviceCareFusion 303, Inc.Class IAlaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.
- 2020-08-12FDA-DeviceCareFusion 303, Inc.Class IAlaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.
- 2020-08-12FDA-DeviceCareFusion 303, Inc.Class IAlaris PCA Module Model 8120, a modular infusion pump and monitoring system
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.
- 2020-08-12FDA-DeviceCareFusion 303, Inc.Class IAlaris Syringe Module Model 8110, a modular infusion pump and monitoring system
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.
- 2020-08-12FDA-DeviceCareFusion 303, Inc.Class IAlaris Pump Module Model 8100, a modular infusion pump and monitoring system
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.
- 2020-08-12FDA-DeviceCareFusion 303, Inc.Class IAlaris System PC Unit Model 8015, a modular infusion pump and monitoring system
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.
- 2020-08-12FDA-DeviceCareFusion 303, Inc.Class IAlaris System PC Unit Model 8000, a modular infusion pump and monitoring system
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.
- 2020-08-05FDA-DeviceOrthoPediatrics CorpClass IIOrthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease Model Number: 00-1300-6053
Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device
- 2020-08-05FDA-DeviceSynthes Produktions GmbHClass IIMatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin.
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 etched with a 12 (representing 12mm).
- 2020-08-05FDA-DeviceHill-Rom, Inc.Class IICentrella Smart+ Bed, Catalog No. P7900 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy.
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.
- 2020-08-05FDA-DeviceHill-Rom, Inc.Class IIProgressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy.
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.
- 2020-08-05FDA-DeviceArthrex, Inc.Class IISterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.
Screws provided in packaging are 5mm shorter than intended
- 2020-08-05FDA-DeviceTELEFLEX MEDICAL INCClass IIRusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Breaking at the point of a welded joint
- 2020-08-05FDA-DeviceTELEFLEX MEDICAL INCClass IIRusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Breaking at the point of a welded joint
- 2020-08-05FDA-DeviceTELEFLEX MEDICAL INCClass IIRusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Breaking at the point of a welded joint
- 2020-08-05FDA-DeviceTELEFLEX MEDICAL INCClass IIRusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Breaking at the point of a welded joint
- 2020-08-05FDA-DeviceTELEFLEX MEDICAL INCClass IIRusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Breaking at the point of a welded joint
- 2020-08-05FDA-DeviceTELEFLEX MEDICAL INCClass IIRusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Breaking at the point of a welded joint
- 2020-08-05FDA-DeviceTELEFLEX MEDICAL INCClass IIRusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Breaking at the point of a welded joint
- 2020-08-05FDA-DeviceMedline Industries IncClass IIClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.
There are reports of the suction catheter coming apart from the device assembly during use.
- 2020-08-05FDA-DeviceMedline Industries IncClass IIClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.
There are reports of the suction catheter coming apart from the device assembly during use.
- 2020-08-05FDA-DeviceIon Beam Applications S.A.Class IIProteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
- 2020-08-05FDA-DeviceChengdu Ai Qin E-commerce Co., LtdClass IITTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses
Colored contact lenses were distributed without FDA clearance.
- 2020-08-05FDA-DeviceChengdu Ai Qin E-commerce Co., LtdClass IITTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lenses
Colored contact lenses were distributed without FDA clearance.
- 2020-08-05FDA-DeviceChengdu Ai Qin E-commerce Co., LtdClass IITTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses
Colored contact lenses were distributed without FDA clearance.
- 2020-08-05FDA-DeviceChengdu Ai Qin E-commerce Co., LtdClass IITTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lenses
Colored contact lenses were distributed without FDA clearance.
- 2020-08-05FDA-DeviceChengdu Ai Qin E-commerce Co., LtdClass IITTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lenses
Colored contact lenses were distributed without FDA clearance.
- 2020-08-05FDA-DeviceChengdu Ai Qin E-commerce Co., LtdClass IITTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact lenses
Colored contact lenses were distributed without FDA clearance.
- 2020-08-05FDA-DeviceChengdu Ai Qin E-commerce Co., LtdClass IITTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses
Colored contact lenses were distributed without FDA clearance.
- 2020-08-05FDA-DeviceMedtronic Navigation, Inc.Class IIStealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.
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 passive trackers simultaneously. While no injuries or illnesses have been reported, If impacted cameras were to be used with both active and passive trackers simultaneously, it would result in system navigation inaccuracy of 6mm.
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