Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-10-24FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks¿ and Ancillary Packs when more than one (1) lot of specific Reagent kits are loaded on the analyzer at the same time. 2. Sample barcodes may be incorrectly read 3. The Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer may not run CEA dilutions at 50x and 100x. The Analyzer may post a Sample Integrity Error when 50x or 100x dilutions are ordered for Carcinoembryonic Antigen (CEA). Dilution factors lower than 50x and neat samples are not affected by this behavior. 4. The Atellica CH 930 Analyzer may continue to display the default reporting units after the reporting units have been changed. 5. The Atellica CH 930 Analyzer may not display results for sample if certain assays are configured to auto-dilute results above or below the assay measuring interval.
- 2018-10-24FDA-DeviceOriGen Biomedical, Inc.Class IIReinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
- 2018-10-24FDA-DeviceOriGen Biomedical, Inc.Class IIECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
- 2018-10-24FDA-DeviceOriGen Biomedical, Inc.Class IIReinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
- 2018-10-24FDA-DeviceOriGen Biomedical, Inc.Class IIReinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
- 2018-10-24FDA-DeviceOriGen Biomedical, Inc.Class IIReinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
- 2018-10-24FDA-DeviceOriGen Biomedical, Inc.Class IIReinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
- 2018-10-24FDA-DeviceSiemens Medical Solutions USA, Inc.Class IIBiograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material Number 10507786 c) Flow 20-4R, Material Number 10528958 d) m Flow 64-4R, Material Number 10529161 e) mCT S(40)-4R, Material Number 10248671 f) mCT S(64)-4R, Material Number 0248672 g) mCT S(20)-3R, Material Number 10534159 h) mCT Flow Edge-4R, Material Number 10528955 i) mCT Flow 40-3R, Material Number 10529158 j) mCT Flow 64-3R, Material Number 10529160 k) mCT X-4R, Material Number 10248670 l) mCT
The terminals on the plug may become loose and overheat.
- 2018-10-24FDA-DeviceSiemens Medical Solutions USA, Inc.Class IIBiograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon and Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
The terminals on the plug may become loose and overheat.
- 2018-10-24FDA-DeviceTerumo Cardiovascular Systems CorporationClass IITerumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
The service manual was not updated at the time of the release of software version 1.30.
- 2018-10-24FDA-DevicePhilips Electronics North America Corp.Class IIPhilips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable pads applied to potential victims of SCA with the following symptoms: 1) Unresponsiveness 2) Absence of normal breathing The HeartStart FR3 is intended for adults and children over 55 pounds (25kg) o
Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur.
- 2018-10-24FDA-DeviceLife Technologies, Corp.Class IIGibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
- 2018-10-24FDA-DeviceLife Technologies, Corp.Class IIGibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
- 2018-10-24FDA-DeviceLife Technologies, Corp.Class IIGibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use SKU 14040141
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
- 2018-10-24FDA-DeviceLife Technologies, Corp.Class IIGibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
- 2018-10-24FDA-DeviceMindray DS USA, Inc. dba Mindray North AmericaClass IIMindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmitters have been connected to a central station. The anomaly causes some ECG waveforms to appear as a flat line at the centralized viewing station and will manifest if more than 64 TD60 transmitters have been connected to a given central station server. Each central station supports only 32 transmitters at a time. For the issue to manifest, the BeneVision DMS needs to be configured to use flexible device assignment, have more than 64 TD60 transmitters, and the workflow must allow 64 TD60s to move around between multiple central stations in the same care area.
- 2018-10-24FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail 125 9 mm x 165 mm, Item Number 816709165 Product Usage: Intended for the fixation of fractures
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
- 2018-10-24FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number 814615360 Product Usage: Intended for the fixation of fractures
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
- 2018-10-24FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail Left 130 11 mm x 400 mm, Item Number 814611400 Product Usage: Intended for the fixation of fractures
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
- 2018-10-24FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail Left 130 11 mm x 380 mm, Item Number 814611380 Product Usage: Intended for the fixation of fractures
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
- 2018-10-24FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 Product Usage: Intended for the fixation of fractures
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
- 2018-10-24FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number 814609360 Product Usage: Intended for the fixation of fractures
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
- 2018-10-24FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail Right 130 13 mm x 360 mm, Item Number 814513360 Product Usage: Intended for the fixation of fractures
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
- 2018-10-24FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 Product Usage: Intended for the fixation of fractures
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
- 2018-10-24FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number 814511360 Product Usage: Intended for the fixation of fractures
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
- 2018-10-24FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number 814511340 Product Usage: Intended for the fixation of fractures
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
- 2018-10-24FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail Right 130 11 mm x 320 mm, Item Number 814511320 Product Usage: Intended for the fixation of fractures
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
- 2018-10-24FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number 814511180 Product Usage: Intended for the fixation of fractures
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
- 2018-10-24FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number 814509320 Product Usage: Intended for the fixation of fractures
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
- 2018-10-24FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 Product Usage: Intended for the fixation of fractures
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
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