Recalls You Should Be Aware Of—Week of September 23, 2018

We’ve compiled a list of recalls issued by the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) from this past week:

Mauna Loa Macadamia Nut Corporation Issues Recall for Products Potential Contaminated with E coli

Mauna Loa Macadamia Nut Corporation is voluntarily recalling all of its products produced at the Keaau facility between Sept. 6 - 21, 2018 due to a potential contamination of Escherichia coli (E. coli). The recall was initiated due to E.coli being detected in the well water and distribution system that supplies the firm’s operations. No illnesses related to the water have been reported to the state.

Mauna Loa is voluntarily recalling their products out of an abundance of caution under the advisement of the Hawaii State Department of Health (DOH).

For a full list of products affected by this recall, check out the recall statement.

Oscor Inc. Issues Recall for Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing (see Picture 1, No. 2 Pin Cap and Cover) may slide and potentially expose the connection wire.

In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system. The analysis of the returned devices attributed the failure to a design change of the cap housing of the pins.

In the last six years, a total of four serious injuries were reported to Oscor which were attributed to a connector cap malfunction causing the lead connector to separate during use potentially leading to an interruption of the pacing system.

No deaths were reported; however, the risk for possible injury is a concern if the connectors separate during use.

For the complete list of product model numbers affected by this recall, consult the official announcement.

Endo Pharmaceuticals Issues Recall for Two Lots of Robaxin Tablets Due to Incorrect Dosing Directions

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily.

The recall includes the following product lots:

Robaxin® 750mg, 100 Count Bottle pack, Lot 216702P1, Expiration Date: September 2020; and

Robaxin® 750mg, 100 Count Bottle pack, Lot 220409P1, Expiration Date: January 2021.

For more information on this recall, check out the recall statement.

Ventana Medical Systems REcalls Detection Kits with Dispenser Issues

Ventana Medical Systems is recalling the detection kits due to leaking and sticking of reagent dispensers which could cause a test result to indicate the absence of a biomarker when, in fact, the person does express the biomarker (false negative). A false negative may result in inappropriate treatment or delay in treatment. The use of the affected product may cause serious adverse health consequences. There are no deaths or serious health problems that have been reported.

The detection kits contain staining chemicals (reagents) used during immunohistochemistry (IHC) lab tests. The dispensers release the staining reagents that change color to indicate a disease state or health condition (biomarkers). Biomarkers are used as an aid in the diagnosis and management of patient treatment for many health conditions, including cancer. The results can also indicate whether a patient is likely to benefit from certain drugs.

To read more about this class I recall, check out the press release.

Pro-Med Instruments Issues Recall for DORO LUCENT Headrest Due to Possible Malfunction

Pro-Med Instruments is recalling the DORO® LUCENT Base Unit, Locking Transitional Member, and Transitional Member because recent design revisions can prevent the headrest from fitting together properly if parts from different revisions are used together. The use of this combination of different revision parts may cause serious adverse health consequences or death.

The DORO Lucent Headrest System is used to support the head and neck during brain and spine surgeries when immobilization is required. The headrest system has several parts including the base unit, the locking transitional member, and transitional member.​​​​​​​

For more information on this medical device recall, read the official statement.