All Recalls

Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the potential for bleeding, unintended tissue injury or loss, and delay in treatment while an alternate device is obtained.

Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in Feet First Supine (FFS).

A potential chemical degradation of Sevoflurane by Lewis acids (metal oxides and metal halides) has been discovered that may result in inhalation and/or skin exposure of hydrogen fluoride.

Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters.

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

Undeclared Fish and Soy

Undeclared milk

Presence of visible mold detected.

Product labeled to be Diet and Zero Sugar in the ingredient statement may contain sugar due to an production error.

Undeclared Egg Allergen

Soycutash Edamame may be contaminated with Listeria monocytogenes.

Products contain undeclared sulfites.