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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Healon V, Part No. 10290045

Abbott Medical Optics Inc. (AMO)

Class I - Dangerous

Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.

Apr 1, 2017 Other Medical Devices View Details →

Bone Dowell Harvest Tubes

Zimmer Biomet

Class I - Dangerous

mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously substituted and etched as 8mm for the actual 8mm subcomponent part.

Apr 12, 2017 Other Medical Devices View Details →

CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rectocele associated with procidentia or prolapse. The inflatoball Pessary contains one (1) Pessary in a double-pocketed sealed clear plastic pouch, one pocket containing the Pessary and one pocket containing the Instructions for Use (IFU).

CooperSurgical

Class I - Dangerous

The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains the product and the Instructions for Use (IFU) correctly states that the pessary is manufactured from latex rubber.

Apr 10, 2017 Surgical Instruments Nationwide View Details →

Savaria SL-1000 Stairlift

Savaria Concord Lifts

Class I - Dangerous

The electrical controller, combined with motor, causes feedback, damaging a component on the control board, starting a fire.

Apr 12, 2017 Other Medical Devices View Details →

ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology.

Roho

Class I - Dangerous

When the Smart Check tool is used to perform a Smart Setup with one of the affected cushions, it may adversely affect the setup process resulting in an improper cushion setup. Sitting on an over inflated or under inflated Sensor Ready Cushion may reduce or eliminate the benefits provided by the cushion, increasing the risk to skin or to other soft tissue.

Mar 20, 2017 Other Medical Devices Nationwide View Details →

Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan

Sysmex America

Class I - Dangerous

Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an internal protective sheet that shields electronic components from salty reagents. Build-up of salt deposits on unprotected electronic components may combust due to heat generated by electronics when instrument cycles. Completed CAPA identified the root cause as supplier providing defective component (sensor ready valve) and the misalignment of the electronic protective shield during manufacturing of the device.

Mar 23, 2017 Other Medical Devices Nationwide View Details →