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.
- 2018-06-06FDA-DeviceArrow International IncClass IIRadial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
Product sterility may be compromised due to unsealed packaging.
- 2018-06-06FDA-DeviceArrow International IncClass IIArterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
Product sterility may be compromised due to unsealed packaging.
- 2018-06-06FDA-DeviceArrow International IncClass IIRadial Arterial Access Kit; Product Code: ASK-04001-BID2
Product sterility may be compromised due to unsealed packaging.
- 2018-06-06FDA-DeviceArrow International IncClass IIMaximal Barrier Drape; Product Code: ASK-04000-HMC
Product sterility may be compromised due to unsealed packaging.
- 2018-06-06FDA-DeviceArrow International IncClass IIMaximal Barrier Drape; Product Code: ASK-01000-UPMS
Product sterility may be compromised due to unsealed packaging.
- 2018-06-06FDA-DeviceArrow International IncClass IIMaximal Barrier Drape; Product Codes: ASK-00376-SU
Product sterility may be compromised due to unsealed packaging.
- 2018-06-06FDA-DeviceArrow International IncClass IIMaximal Barrier Drape; Product Codes: ASK-00002-1A
Product sterility may be compromised due to unsealed packaging.
- 2018-06-06FDA-DeviceArrow International IncClass IIMaximal Barrier Drape; Product Codes: ASK-00001-1A
Product sterility may be compromised due to unsealed packaging.
- 2018-06-06FDA-DeviceArrow International IncClass IISnapLock" Catheter/Syringe Adapter; Product Code: AS-05500
Product sterility may be compromised due to unsealed packaging.
- 2018-06-06FDA-DeviceArrow International IncClass IIEpidural Needle; Product Codes: AN-05501 and AN-05505
Product sterility may be compromised due to unsealed packaging.
- 2018-06-06FDA-DeviceArrow International IncClass IISpring Wire Guide Introducer Needle; Product Codes: AN-04320 and AN-04418
Product sterility may be compromised due to unsealed packaging.
- 2018-06-06FDA-DeviceArrow International IncClass IIEchogenic Introducer Needle; Product Code: AN-04318
Product sterility may be compromised due to unsealed packaging.
- 2018-06-06FDA-DeviceArrow International IncClass IIContinuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18080-N, AB-18110-N
Product sterility may be compromised due to unsealed packaging.
- 2018-06-06FDA-DeviceArrow International IncClass IICatheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires; Product Code: AI-07000
Product sterility may be compromised due to unsealed packaging.
- 2018-06-06FDA-DeviceRoche Molecular Systems, Inc.Class IIMagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications. The main features of the system are : Scalable purification of 1 to 24 samples Primary/secondary tube handling Inventory and sample management via barcodes Efficient order management via host The MagNA Pure 24 System offers 4 run types:
Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.
- 2018-06-06FDA-DeviceDynarex CorporationClass IIDynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715, Model Number 5227 A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.
The device is equipped with a dial that has an inaccurate flow rate indicator.
- 2018-06-06FDA-DeviceDraeger Medical, Inc.Class IICarina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.
The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming contaminated in the affected devices.
- 2018-06-06FDA-DeviceGenesee BioMedical, Inc.Class IISternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
Failure in a retractor blade due to corrosion. In the area of the blade where the bearing/button meets the blade body, corrosion can form, weakening the welded joint and may cause the bearing/button to break.
- 2018-06-06FDA-DeviceGyrus Acmi, IncorporatedClass IIGyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs that connect to a generator on one end and a plug that connects to a Gyrus ACMI working element on the other end. They are provided non-sterile and are reusable. The cord is designed to be used with Gyrus ACMI GOCUS 640, Bovie, and other general purpose monopolar electrosurgical generators and appropriate electrodes a
There is a potential for the cord to spark and cause a fire.
- 2018-06-06FDA-DeviceRespire MedicalClass IIRespire Pink H/S Oral Sleep Apnea Device
Potential for device breakage during use
- 2018-06-06FDA-DeviceRespire MedicalClass IIRespire Pink H/S Oral Sleep Apnea Device
Potential for device breakage during use
- 2018-06-06FDA-DeviceRespire MedicalClass IIRespire Pink+ Hard Oral Sleep Apnea Device
Potential for device breakage during use
- 2018-06-06FDA-DeviceRespire MedicalClass IIRespire Pink+ Hard/Soft Oral Sleep Apnea Device
Potential for device breakage during use
- 2018-06-06FDA-DeviceRespire MedicalClass IIRespire Pink Series EF+ Oral Sleep Apnea Device.
Potential for device breakage during use
- 2018-06-06FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IISyva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
Lot J1 of the Syva¿ EMIT¿ 2000 Theophylline Assay, when run on a Beckman AU Clinical Chemistry System, may exhibit increased imprecision for commercially available controls and for patient samples.
- 2018-06-06FDA-DeviceOlsen MedicalClass IISymmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8" (20.3cm) Serrated Tips, REF 20-2650K, QTY 10 (b) Insulated Bayonet Forceps 8.25" (21.0cm) Serrated 1.5mm Tips, REF 20-2920HK, QTY 10 (c) Insulated Bayonet Forceps 8.5" (21.6cm) Serrated 1.5mm Tips, REF 20-2920K, QTY 10 (d) Insulated Bayonet Forceps 7.5" (19.1cm) 1.5mm Cathedral Tips, REF 20-2960HK, QTY 10
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
- 2018-06-06FDA-DeviceOlsen MedicalClass IISymmetry Olsen bipolar forceps: (a1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311, QTY 5 (b1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311R, QTY 5 (c1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 1.0mm Tips, REF 20-0321, QTY 5 (d1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 1.5mm Tips, REF 20-0331, QTY 5 (e1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth, 1.5mm Tips, REF
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
- 2018-06-06FDA-DeviceOlsen MedicalClass IISymmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8" Diameter Pin, TUR Connector, 10' (3.0m), REF 92002, QTY 50 (b) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2106, QTY 10 (c) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2110, QTY 10 Designed to bring high frequency electrical power from the electrosurgical generator to the active.
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
- 2018-06-06FDA-DeviceOlsen MedicalClass IISymmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument Connector, 12' (3.6m), REF 87500, QTY 50 (b) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102, QTY 10 (c) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102SPC, QTY 10 (d) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1103, QTY 50 (e) Bipolar Cord, Twin Pin Connector, Angled 45o, 12' (3.6m), REF 40-1104, QTY 10 (f) Bipolar Cord, 28 mm Fixed Pin Connector, REF 40-1105-28, QTY 10
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
- 2018-06-06FDA-DeviceOlsen MedicalClass IISymmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50 (b) Button Switchpen, w/ Standard Blade Electrode, REF 75530, QTY 50 (c) Rocker Switchpen, w/ Standard Blade Electrode, REF 75610, QTY 50 (d) Button Switchpen, w/ Extendable Blade Electrode, 10 mm Exposure, REF 75800, QTY 25 (e) Button Switchpen, w/ Extendable Blade Electrode, 2 mm Exposure, REF 75810, QTY 25 (f) Button Switchpen, w/ Extendable Needle Electrode, 2 mm Exposure, REF 75820, Q
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
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