All Recalls

95,038 total recalls in our database

V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

Vital Scientific N.V.

🏥 Medical Devices Class I - Dangerous

Instrument stopped working due to a software lockup, and no patient results are produced.

Jan 18, 2016 Diagnostic Equipment View Details →

MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800 Product Usage: Medline Surgical Clipper is intended for the removal of body hair from the patient as required prior to surgery or other minor procedures.

Medline Industries

🏥 Medical Devices Class I - Dangerous

The recall is being conducted due to a potential defective component on the circuit board causing the charger base to overheat which could result in a charger base malfunction.

Sep 6, 2019 Surgical Instruments Nationwide View Details →

Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review

Elekta

🏥 Medical Devices Class I - Dangerous

It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.

Sep 4, 2019 Infusion Pumps Nationwide View Details →

APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,

Abbott Laboratories

🏥 Medical Devices Class I - Dangerous

The firm identified customer sites where modules which the safety pacemaker label is missing. Information regarding the label included in the Operations Manual has been updated to specify: 1) the risk of malfunction applies to anyone with a pacemaker who may work on these modules; 2) the minimum safety distance has increased to 200 mm (7.87") from transport mechanisms. Any person with a pacemaker must not get closer than this distance from modules axes.

Sep 7, 2018 Infusion Pumps Nationwide View Details →

B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032

B. Braun Medical

🏥 Medical Devices Class I - Dangerous

Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).

May 1, 2019 Infusion Pumps View Details →

Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Code:AK-42854-P1A - Product Usage: The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.

Arrow International

🏥 Medical Devices Class I - Dangerous

Products may contain the incorrect banner card within the kit

Aug 6, 2019 Surgical Instruments Nationwide View Details →

DigitalDiagnost C50, Stationary X-ray System

Philips Healthcare

🏥 Medical Devices Class I - Dangerous

During recent evaluations of the Philips DigitalDiagnost C50 system, Philips identified a missing label. This notification is intended to provide you with information regarding what the issue is, and relevant affected product, the actions you are required to take and the actions planned by Philips to correct the issue. If you need any or further information or support concerning this issue, please contact your local Philips representative or Philips Customer Service: 1-800-722-9377.

Dec 21, 2018 Other Medical Devices View Details →

Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758

Philips North America

🏥 Medical Devices Class I - Dangerous

The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging for infant/child pad cartridges. The infant/child pad cartridge is designed for use with the defibrillator An Infant/Child pad cartridge should not be used on an adult because it delivers lower energy (50 J vs 150 J) than the Adult pads cartridge and may therefore not be effective on an adult.

Aug 8, 2018 Other Medical Devices Nationwide View Details →

Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320

Sentinel CH SpA

🏥 Medical Devices Class I - Dangerous

Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient results

Jun 28, 2019 Infusion Pumps Nationwide View Details →

Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2. 40" Snap Leadwire, Blue; 3. 24" Snap Leadwire, Red; 4. 40" Snap Leadwire, Red; 5. 24" Snap Leadwire, Green; 6. 40" Snap Leadwire, Green; 7. 24" Snap Leadwire, Brown; 8. 40" Snap Leadwire, Brown; 9. 24" Snap Leadwire, Orange; 10. 40" Snap Leadwire, Orange; 11. 24" Snap Leadwire, White; 12. 40" Snap Leadwire, White; 13. 24" Snap Leadwire, Black; 14. 40" Snap Leadwire, Black; 15. 24" Snap Leadwire, Yellow; 16. 40" Snap Leadwire, Yellow; 17. 24" Snap Leadwire, Set of 5; 18. 24" Snap Leadwire, Set of 7; 19. 40" Snap Leadwire, Set of 5; 20. 40" Snap Leadwire, Set of 7; 21. 24" Snap Leadwire, Set of 5; 22. 40" Snap Leadwire, Set of 5; 23. 48" Gold Cup Leadwires, Blue; 24. 48" Gold Cup Leadwires, Red; 25. 48" Gold Cup Leadwires, Green; 26. 48" Gold Cup Leadwires, Brown; 27. 48" Gold Cup Leadwires, Orange; 28. 48" Gold Cup Leadwires, White; 29. 48" Gold Cup Leadwires, Black; 30. 48" Gold Cup Leadwires, Yellow; 31. 48" Gold Cup Leadwires, Set of 5; 32. 48" Gold Cup Leadwires, Set of 8; Product Usage: The snap electrode leads are used in conjunction with disposable electrodes and the Gold Cup electrodes are reusable electrodes and leads. Both types of electrodes and leads are used for evoked potential testing for audiological, neurological and/or vestibular testing. The electrode leads are connected to the main device by the electrode lead connector and the electrode is attached to the patient contact end of electrode lead.

GN Otometrics

🏥 Medical Devices Class I - Dangerous

The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.

Aug 1, 2019 Diagnostic Equipment Nationwide View Details →

The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is designed to reduce bleeding at implant and thereby eliminates the operative preclotting step, including cumbersome autoclave techniques. The collagen is designed to be gradually resorbed by the patient. The CONCENTRICRIMP pleat and GUIDELINE stripe are also featured. In addition to collagen, the graft also contains glycerol as a softening agent.

GETINGE US SALES

🏥 Medical Devices Class I - Dangerous

Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Bifurcated Graft product with the diameter size of 16 x 9 mm is likely incorrectly packed inside of the carton which was labeled to contain a HEMASHIELD PLATINUM Woven Double Velour Vascular Graft product with the diameter size of 16 x 8 mm ((REF: M00202166168P0, Lot: 18K31, SN: 1190443415, size 16 x 8 mm).

Aug 22, 2019 Implants & Prosthetics View Details →