All Recalls

95,094 total recalls in our database

The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.

Jun 22, 2016 Diagnostic Equipment View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.

Jun 23, 2016 Other Medical Devices Nationwide View Details β†’

US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

Jun 22, 2016 Infusion Pumps Nationwide View Details β†’

A defective rotor yoke on Allegra X-5 allows improper rotor seating on the hub resulting in possible rotor failure if the buckets are loaded in an imbalanced configuration.

Feb 5, 2016 Diagnostic Equipment Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.

Jun 23, 2016 Other Medical Devices Nationwide View Details β†’

Endotine Transbleph 3.5 (CFD-080-0167)

MicroAire Surgical Instruments

πŸ₯ Medical Devices Class I - Dangerous

MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to minor mislabeling ( the front label is correct, but the side label lists an incorrect part number, i.e. CFD-080-0177).

May 6, 2016 Other Medical Devices View Details β†’

US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

Jun 22, 2016 Infusion Pumps Nationwide View Details β†’

A software defect was discovered that causes images to be out of context with clinical information.

Feb 18, 2013 Diagnostic Equipment Nationwide View Details β†’

Product mix-up. The Avenir MΒΏller Stem 6 lateral uncemented might be placed in the packaging of the Avenir MΒΏller Stem 4 standard uncemented and vice versa. Potential for delay in surgery, and/or potential for use of incorrect implant which may in turn lead dismetry in patient and possibly the need for revision.

Jun 30, 2016 Implants & Prosthetics Nationwide View Details β†’

Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

Apr 6, 2016 Implants & Prosthetics Nationwide View Details β†’

Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be generated when using VITROS Ca Slides, GEN29, and the VITROS 250/350/950/5,1 FS, 4600 Chemistry System or the VITROS 5600 Integrated System. An increase in negatively biased calcium results complaints prompted the investigation that identified this product issue.

May 18, 2016 Diagnostic Equipment Nationwide View Details β†’

Fire alarm pull stations

Unknown Manufacturer

🏠 Consumer Products Class I - Dangerous

The pull handle on the fire alarm pull station can break when manually pulled and fail to activate the alarm system.

Aug 3, 2016 Other Consumer Products Nationwide View Details β†’

Stainless Steel Straws

Unknown Manufacturer

🏠 Consumer Products Class II - Moderate

The stainless steel straws are rigid and can poke children in the mouth, posing a risk of injury.

Aug 2, 2016 Clothing & Accessories Nationwide View Details β†’

Utility vehicles

Deere & Company, of Moline, Ill.

🏠 Consumer Products Class I - Dangerous

The fuel hose could leak or separate when the fuel system is pressurized, posing a fire hazard.

Jul 28, 2016 Other Consumer Products Nationwide View Details β†’

Ice axes

STUBAI ZMV GmbH, of Austria

🏠 Consumer Products Class III - Low Risk

The knife in the axe handle can detach, posing a laceration or impact hazard to the user or bystanders.

Jul 28, 2016 Clothing & Accessories Nationwide View Details β†’